CRITERIA FOR ACCEPTABILITY OF RADIOLOGICAL, NUCLEAR MEDICINE ...

RADIATION CRITERIA FOR

ACCEPTABILITY OF MEDICAL RADIOLOGICAL

EQUIPMENT USED IN DIAGNOSTIC RADIOLOGY, NUCLEAR MEDICINE AND

RADIOTHERAPY

FINAL DRAFT AMENDED-V1.4-091001

E U R O P E A N C O M M I S S I O N

C O N T R A C T N O . T R E N / 0 7 / N U C L / S 0 7 . 7 0 4 6 4

Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment

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CONTENTS

CONTENTS _________________________________________________________________ 3

1. INTRODUCTION _________________________________________________________ 5 1.1. Purpose and Background____________________________________________________ 5 1.2. Basis for Criteria of Acceptability in European Directives __________________________ 7

1.2.1. Requirements of the Medical Exposure Directive_____________________________________7 1.2.2. Wider context, the MDD Directive and Equipment Standards ___________________________9

1.3. To whom this document is addressed ________________________________________ 11 1.4. Criteria of Acceptability ____________________________________________________ 12

1.4.1. Approaches to Criteria_________________________________________________________12 1.4.2. Suspension Levels ____________________________________________________________13 1.4.3. Identifying and Selecting Criteria ________________________________________________15

1.5. Special Considerations, Exceptions and Exclusions ______________________________ 17 1.5.1. Special Considerations_________________________________________________________17 1.5.2. Exceptions __________________________________________________________________18 1.5.3. rapidly evolving technologies ___________________________________________________18 1.5.4. Exclusions___________________________________________________________________19

1.6. Establishing criteria of acceptability have been met _____________________________ 19

2. DIAGNOSTIC RADIOLOGY ________________________________________________ 22 2.1. Introduction _____________________________________________________________ 22 2.2. X-Ray Generators and equipment for General Radiography_______________________ 23

2.2.1. Introduction _________________________________________________________________23 2.2.2. Criteria for X-Ray Generators, and General Radiography ______________________________26

2.3. Radiographic Image Receptors and Viewing Facilities____________________________ 29 2.3.1. Introduction _________________________________________________________________29 2.3.2. Criteria for Image Receptors and Viewing Facilities __________________________________31

2.4. Mammography___________________________________________________________ 37 2.4.1. Introduction _________________________________________________________________37 2.4.2. Measurements_______________________________________________________________38

2.5. Dental Radiography _______________________________________________________ 41 2.5.1. Introduction _________________________________________________________________41 2.5.2. Intra-Oral Systems ____________________________________________________________41 2.5.3. Criteria for Dental Radiography__________________________________________________42 2.5.4. Panoramic radiography ________________________________________________________43 2.5.5. Cephalometry _______________________________________________________________43

2.6. Fluoroscopic Systems______________________________________________________ 44 2.6.1. Introduction _________________________________________________________________44 2.6.2. Criteria for Acceptability of Fluoroscopy Equipment _________________________________45

2.7. Computed Tomography____________________________________________________ 46 2.7.1. Introduction _________________________________________________________________46 2.7.2. Criteria for Acceptability of CT Systems ___________________________________________48

2.8. Dual Energy X-ray Absorptiometry ___________________________________________ 49 2.8.1. Introduction _________________________________________________________________49 2.8.2. Acceptability Criteria for DXA Systems ____________________________________________49


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3. NUCLEAR MEDICINE EQUIPMENT__________________________________________ 50 3.1. Introduction _____________________________________________________________ 50 3.2. Nuclear Medicine Therapeutic Procedures ____________________________________ 52

3.2.1. Introduction _________________________________________________________________52 3.2.2. Activity Measurement Instruments_______________________________________________53 3.2.3. Contamination Monitors _______________________________________________________53 3.2.4. Patient Dose Rate Measuring Instruments _________________________________________54 3.2.5. Radiopharmacy Quality Assurance Programme _____________________________________55

3.3. Radiopharmacy for Gamma Camera based Diagnostic Procedures _________________ 56 3.3.1. Introduction _________________________________________________________________56 3.3.2. Activity Measurement Instruments_______________________________________________57 3.3.3. Gamma Counters _____________________________________________________________57 3.3.4. Thin Layer Chromatography Scanners_____________________________________________58 3.3.5. Contamination monitors _______________________________________________________58

3.4. Radiopharmacy for Positron Emission Based Diagnostic Procedures________________ 59 3.3 Gamma Camera based Diagnostic Procedures__________________________________ 59

3.3.1 Introduction ___________________________________________________________________59 3.4.1. Planar Gamma Camera ________________________________________________________60 3.4.2. Whole Body IMAGING System___________________________________________________61 3.4.3. SPECT System________________________________________________________________62 3.4.4. Gamma Cameras used for Coincidence Imaging_____________________________________63

3.5. Positron Emission Diagnostic Procedures______________________________________ 64 3.5.1. Introduction _________________________________________________________________64 3.5.2. Positron Emission Tomography System ___________________________________________65 3.5.3. Hybrid Diagnostic Systems______________________________________________________66

3.4 Intra-Operative Probes ____________________________________________________ 67

4 RADIOTHERAPY ________________________________________________________ 69

3.6. Introduction _____________________________________________________________ 69 3.3 Linear accelerators________________________________________________________ 70 3.7. Simulators_______________________________________________________________ 73 3.8. CT Simulators ____________________________________________________________ 76 3.9. Cobalt-60 units ___________________________________________________________ 79 3.10. Kilovoltage Units _______________________________________________________ 81 3.11. Brachytherapy _________________________________________________________ 82 3.12. Treatment Planning Systems______________________________________________ 83 3.13. Dosimetry Equipment ___________________________________________________ 84 3.14. Radiotherapy Networks__________________________________________________ 85

APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE_____________________ 88

APPENDIX 2 AUTOMATIC EXPOSURE CONTROL __________________________________ 89

APPENDIX 3 EQUIPMENT ____________________________________________________ 90

REFERENCES & SELECTED BIBLIOGRAPHY _______________________________________ 92

ACKNOWLEDGEMENTS_____________________________________________________ 103


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1. INTRODUCTION 1

1.1. PURPOSE AND BACKGROUND 2

The purpose of this publication is to specify minimum performance standards for 3

radiological, nuclear medicine and radiotherapy equipment. The criteria of 4

acceptability presented here are based on levels of performance that prompt 5

intervention and will result in the use of the equipment being curtailed or terminated, 6

if not corrected. The criteria are produced in response to Directive 97/43/Euratom, 7

which requires that medical exposures be justified and carried out in an optimized 8

fashion. To give effect to this Directive, Article 8.3 stipulates that Member States 9

shall adopt criteria of acceptability for radiological equipment in order to indicate 10

when action is necessary, including, if appropriate, taking the equipment out of 11

service. In 1997, the Commission published Radiation Protection 91: Criteria for 12

acceptability of radiological (including radiotherapy) and nuclear medicine 13

installations (EC, 1997), in pursuit of this objective. This specified minimum criteria 14

for acceptability and has been used to this effect in legislation, codes of practice and 15

by individual professionals throughout the member states and elsewhere in the world. 16

RP 91 considered diagnostic radiological installations including conventional and 17

computed tomography, dental radiography, and mammography, radiotherapy 18

installations and nuclear medicine installations. However, development of new 19

radiological systems and technologies, improvements in traditional technologies and 20

changing clinical/social needs have created circumstances where the criteria of 21

acceptability need to be reviewed to ensure the principles of justification and 22

optimization are upheld. To give effect to this, the Commission, on the advice of the 23

Article 31 Group of Experts, initiated a study aimed at reviewing and updating RP 91 24

(EC, 1997), which in due course has led to this publication. 25

This revised publication is, among other features, intended to: 26

1. Update existing acceptability criteria. 27

2. Update and extend acceptability criteria to new types of installations. In diagnostic 28

radiology, the range and scope of the systems available has been greatly 29


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extended (e.g. computed radiography, digital radiography, digital fluoroscopy, 1

multislice computed tomography (CT) and dual energy x-ray absorptiometry 2

(DXA)). In nuclear medicine, there are Positron Emission Tomography (PET) 3

systems and hybrid scanners. In radiotherapy, there are linear accelerators with 4

multileaf collimators capable of intensity modulated radiotherapy (IMRT). 5

3. Identify an updated and more explicit range of techniques employed to assess 6

criteria of acceptability, 7

4. Provide criteria that have a reasonable opportunity of being accepted, and that 8

are achievable throughout the member states. 9

5. Deal, where practical, with the implications for screening techniques, paediatrics, 10

high dose techniques and other special issues noted in the 1997 Directive. 11

6. Promote approaches based on an understanding of and that attempt to achieve 12

consistency with those employed by the Medical Devices Directive (MDD) 13

(Council Directive 93/42/EEC), industry, standards organizations and professional 14

bodies. 15

7. Make practical suggestions on implementation and verification. 16

To achieve this, the development and review process has involved a wide range of 17

individuals and organizations, including experts from relevant professions, 18

professional bodies, industry, standards organizations and relevant international 19

organizations. It was easier to achieve the last objective with radiotherapy than with 20

diagnostic radiology. This is because of a long tradition of close working relationships 21

between the medical physics and international standards communities, which has 22

facilitated the development and adoption of common standards in radiotherapy. An 23

attempt has been made, with the cooperation of the International Electrotechnical 24

Commission (IEC), to import this approach to the deliberations on diagnostic 25

radiology and to extend it, where it already exists, in nuclear medicine. 26

The intent has been to define parameters essential to the assessment of the 27

performance of radiological medical installations and set up tolerances within which 28

the technical quality and equipment safety standards for medical procedures are 29


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ensured. The methods for performance assessment recommended generally rely on 1

non-invasive measurements open to the end user. This publication will benefit the 2

holder of radiological installations, bodies responsible for technical surveillance and 3

authorities charged with verifying compliance of installations with regulations on 4

grounds of technical safety. However, it is important to bear in mind that the present 5

publication follows the precedent established in RP 91, is limited to the equipment 6

and does not address wider issues such as those associated with, for example, the 7

requirements for buildings and installations, information technology (IT) systems such 8

as picture archiving and communication systems (PACS) and/or radiological 9

information systems (RIS). 10

1.2. BASIS FOR CRITERIA OF ACCEPTABILITY IN EUROPEAN DIRECTIVES 11

1.2.1. REQUIREMENTS OF THE MEDICAL EXPOSURE DIRECTIVE 12

The work of the European Commission in the field of radiation protection is governed 13

by the Euratom Treaty and the Council Directives made under it. The most 14

prominent is the Basic Safety Standards Directive (BSS) on the protection of 15

exposed workers and the public (Council Directive 80/836/Euratom), revised in 1996 16

(Council Directive 96/29/Euratom). Radiation protection of persons undergoing 17

medical examination was first addressed in Council Directive 84/466/Euratom. This 18

was replaced in 1997 by Council Directive 97/43/EURATOM (MED) on health 19

protection of patients against the dangers of ionizing radiation in relation to medical 20

exposure. This prescribes a number of measures to ensure medical exposures are 21

delivered under appropriate conditions. It makes necessary the establishment of 22

quality assurance programmes and criteria of acceptability for equipment and 23

installations. These criteria apply to all installed radiological equipment used with 24

patients. 25

The directive also deals with the monitoring, evaluation and maintenance of the 26

required characteristics of performance of equipment that can be defined, measured 27

and controlled. In particular, it requires that all doses arising from medical exposure 28

of patients for medical diagnosis or health screening programmes shall be kept as 29

low as reasonably achievable consistent with obtaining the required diagnostic 30


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information, taking into account economic and social factors (ALARA). Specifically, 1

the requirements in respect of criteria of acceptability are stated as follows: 2

“Competent authorities shall take steps to ensure that necessary measures are taken 3

by the holder of the radiological installation to improve inadequate or defective 4

features of the equipment. They shall also adopt specific criteria of acceptability for 5

equipment in order to indicate when appropriate remedial action is necessary, 6

including, if appropriate, taking the equipment out of service.” 7

Additional requirements in respect of image intensification and dose monitoring 8

systems are explicitly specified. These extend to all new equipment which: 9

“shall have, where practicable, a device informing the practitioner of the quantity of 10

radiation produced by the equipment during the radiological procedure.” 11

Finally Article 9 requires that: 12

“Appropriate radiological equipment ----- and ancillary equipment are used for the 13

medical exposure 14

• of children, 15

• as part of a health screening programme, 16

• involving high doses to the patient, such as interventional radiology, computed 17

tomography or radiotherapy.” 18

And that: 19

“Special attention shall be given to the quality assurance programmes, including 20

quality control measures and patient dose or administered activity assessment, as 21

mentioned in Article 8, for these practices.” 22

Practical consequences of these requirements are that: 23


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1. Acceptance testing must be carried out before the first use of the equipment 1

for clinical purposes to ensure it complies with its performance specification 2

and to provide reference values for future performance testing. 3

2. Further performance testing must be undertaken on a regular basis, and after 4

any major maintenance procedure. 5

3. Necessary measures must be taken by the holder of the radiological 6

installation to improve inadequate or defective features of the equipment. 7

4. Competent authorities must adopt specific criteria of acceptability for 8

equipment in order to indicate when appropriate action is necessary, including 9

taking the equipment out of service. 10

5. Appropriate quality assurance programmes including quality control measures 11

must be implemented by the holder of the radiological installation. 12

This publication deals with the first four points and will be germane to some aspects 13

of the fifth. It updates and extends the advice provided in 1997 in RP 91 (EC, 1997). 14

However, this document is not intended to act as a guide to quality assurance or 15

quality control programmes, which are comprehensively dealt with elsewhere (CEC 16

2006; APPM 2006a, b; IPEM 2005a, b; AAPM 2002; BIR 2001; Seibert 1999; IPEM, 17

1997a, b, c). 18

1.2.2. WIDER CONTEXT, THE MDD DIRECTIVE AND EQUIPMENT STANDARDS 19

Since 1993, safety aspects of design, manufacturing and placing on the market of 20

medical devices are dealt with by MDD. It is managed by the European Directorate 21

General Enterprise; its main goal is to define and list the Essential Requirements, 22

which must be fulfilled by Medical Devices. When such a device is in compliance 23

with the Essential Requirements of the MDD, it can be “CE marked”, which opens the 24

full European market to the product. 25

There are a number of ways with which manufacturers can demonstrate that their 26

products meet the Essential Requirements of the MDD; the one of most interest here 27

involves international standards. Further, demonstration of conformity with the 28


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essential requirements must include a clinical evaluation. Any undesirable side-1

effects must constitute an acceptable risk when weighted against the performance 2

intended. For the types of system that are the subject of this publication, 3

demonstration of the essential requirements can be achieved by the procedures 4

described in the directive annexes. Conformity of all or part of these requirements 5

can be demonstrated or verified through compliance with harmonised international 6

standards. These are standards that specify essential requirements for the basic 7

safety and essential performance of the device, such as those issued by the IEC or 8

Comité Européen de Normalisation Electrotechnique (CENELEC). 9

Although the MDD includes requirements for devices emitting ionising radiation, this 10

does not affect the authorisations required by the directives adopted under the 11

Euratom treaty when the device is brought into use. In this regard, the Euratom 12

Treaty directives have precedence over the MDD. Conformity with an IEC or 13

CENELEC standard will frequently be included as part of the suppliers’ specification 14

and will be confirmed during contractual acceptance (acceptance testing) of the 15

equipment by the purchaser. On the other hand the acceptability criteria in this 16

publication must be met during the useful life of the equipment and its compliance 17

with them will generally be regularly assessed. 18

The MDD was substantially amended by Directive 2007/47/EC. The amendments 19

include an undertaking by the manufacturer to institute and keep up to date a 20

systematic procedure to review experience gained from devices in the post-21

production phase and to implement appropriate means to apply any necessary 22

corrective action. Furthermore, the clinical evaluation and its documentation must 23

be actively updated with data obtained from the post-market surveillance. Where 24

post-market clinical follow-up as part of the post-market surveillance plan for the 25

device is not deemed necessary, this must be duly justified and documented. 26

In transposing these European directives into national law, the acceptability criteria 27

required by the MED may be transposed into national law using country specific 28

criteria and approaches. It is clear that this may undermine the applicability essential 29

performance standards as required by the MDD or through compliance with the 30

international standardisation system. Such an approach conflicts with the concept of 31

free circulation and suppression of barriers to trade, which is one of the goals of the 32


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EU in general and the MDD in particular. To avoid these difficulties there is an 1

urgent and clear need for harmonisation between the requirements of the two 2

directives (MDD and MED). Thus it is desirable that all EU countries both transpose 3

the MED requirement for criteria of acceptability in a consistent fashion that will not 4

harm the efforts under the MDD, the standards and CE marking systems, to ensure 5

free circulation of goods and suppress trade barriers. The approach advocated in 6

this publication is consistent with this objective. 7

Thus, care must be exercised transposing the requirements of the MED based on 8

either partial or inappropriate adoption of this publication as national legislation. 9

Where this is envisaged, some caution is necessary and due discretion must be 10

allowed in respect of the clinical situations envisaged in this introduction and the 11

associated technology specific sections. Furthermore, adopting a regulation based 12

solely on national radiation protection considerations without due regard for the 13

issues arising from the MDD is likely to prove counterproductive for both suppliers 14

and end users. At a national level, the solution adopted should ensure patient safety 15

while fostering a cooperative framework between industry, standards, end users and 16

regulators. Internationally, there is a clear need for harmonization and a level of 17

uniformity between countries in recognition of the global nature of the equipment 18

supply industry. It is further necessary that there be harmonization between industry 19

and users, at least in terms of the methodologies employed. 20

1.3. TO WHOM THIS DOCUMENT IS ADDRESSED 21

Regulatory documents and standards, with respect to equipment performance, can 22

be addressed to or focused primarily on the needs or obligations of a particular 23

group. For example, the standards produced by IEC and CENELEC are primarily 24

aimed at manufacturers and suppliers. Many of the tests they specify are type tests 25

that could not be done in the field. 26

However, the possible audiences for this publication include holders, end users, 27

regulators, industry and standards organizations. It is recognized that each of these 28

has a necessary interest in this publication and its application. It was recognized that 29

the primary audience for the publication is the holders and end-users of the 30

equipment (specifically, the health agencies, hospitals, other institutions, 31


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practitioners, medical physicists and other staff and agents, who deploy the 1

equipment for use with patients). In addition, it was recognized that it must reflect the 2

requirements of regulators when they are acting in the medical area in the interests 3

of end users and/or patients. This is in keeping with the precedent implicitly 4

established through the scope and format adopted for RP 91. This publication 5

addresses the needs of these groups while taking due account of the reality of 6

globalization of the industry, standards and the harmonization objectives viz a viz the 7

MDD noted elsewhere. The technical parts of Sections 2, 3, and 4 assume those 8

reading and using them are familiar with this introduction and have a good working 9

knowledge of the relevant types of equipment and appropriate testing regimes. 10

1.4. CRITERIA OF ACCEPTABILITY 11

1.4.1. APPROACHES TO CRITERIA 12

Approaches to describing the acceptability and performance of equipment have 13

varied. They inevitably include requirements specifically prescribed in the directive, 14

such as: 15

“In the case of fluoroscopy, examinations without an image intensification or 16

equivalent techniques are not justified and shall therefore be prohibited”, 17

or, 18

“Fluoroscopic examinations without devices to control the dose rate shall be limited 19

to justified circumstances.” 20

With respect to other areas, they range from provision of hard numerical values for 21

performance indices to detailed specification of measurement methodologies without 22

indicating the performance level to be accepted. The latter approach has come to be 23

favoured in many of the standards issued by bodies like IEC or CENELEC and by 24

some professional bodies.1 While this approach has the advantage that it is 25

1 The IEC is the world's leading organization that prepares and publishes International Standards for all electrical, electronic and related technologies. IEC standards cover a vast range of technologies, including power generation, transmission and distribution to home appliances and office equipment, semiconductors, fibre optics, batteries, and medical devices to mention just a few. Many, if not all, of the markets involved are global. Within the EU CENELEC is the parallel standards organization and in practice adopts many IEC standards as its own aligning them within the European context.


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easier/possible to get consensus on it among the manufacturers, professions and 1

other interests involved, it also has some disadvantages. These include an evident 2

lack of transparency, associated limitations on accountability and risks of 3

misapplication in the hands of inexperienced users. 4

A comprehensive, consistent suite of approaches to performance and safety 5

assessment of radiological equipment has been proposed by the UK Institute of 6

Physics and Engineering in Medicine (IPEM, 2005a, b; IPEM, 1997a, b, c]. The 7

American Association of Physics in Medicine (AAPM,, 2006a, b, 2005, 2002) and 8

British Institute of Radiology (BIR, 2001) have also, among other professional 9

organizations, published much useful material. The IPEM system is based on the 10

assumption that deviations from the baseline performance of equipment on 11

installation will provide an adequate means of detecting unsafe or inadequately 12

performing equipment. This approach is questionable within the meaning of criteria 13

of acceptability in the MED; if the baseline is, for one reason or another, 14

unsatisfactory, there are no criteria on which it can be rejected. In light of this issue, 15

the approach more recently favoured by IPEM and many standards organizations 16

has not been adopted in most instances. Where possible, the emphasis has been to 17

propose firm suspension levels. This is consistent with the approach adopted in 18

many countries, including, for example, France, Germany, Belgium, Spain, Italy, 19

Luxembourg and others which have adopted hard limits for performance values 20

based on RP 91 or other sources. 21

1.4.2. SUSPENSION LEVELS 22

A critical reading of the directive, RP 91 and the professional literature reveals some 23

shift or “creep” in the meaning of the terms remedial and suspension level since they 24

came into widespread use in the mid 1990s. In the interest of clarity, we have 25

redefined them in a way that is consistent with both their usage in the Directive and 26

their current usage, as follows: 27

Definition of Suspension Levels: 28

A level of performance that requires the immediate removal of the equipment 29

from use. 30


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Following a documented risk assessment involving the Medical Physics Expert 1

(MPE) and the practitioner, the suspended equipment may be considered for use in 2

limited circumstances. The holder and the operators must be advised in writing of the 3

suspension and/or the related limitation(s) in use. 2 4

A suspension level not being met requires that the equipment is taken out of service 5

immediately. Not meeting the level makes the equipment unsafe, or performance so 6

poor, that it would be unacceptable to society. The level is based on minimum 7

standards of safety and performance that would be acceptable in the EU and 8

represent the expert judgement of the working group and reviewers based on their 9

knowledge of what is acceptable among their peers and informed by the social, legal 10

and political circumstances that prevail in the EU. When suspension levels are 11

reached the equipment must be removed from use (or restricted in use) with patients, 12

either indefinitely or until it is repaired and again satisfies the criteria. 13

It is also possible that the equipment will pass an evaluation based on suspension 14

levels but be unsatisfactory in some other way. This may be because we have 15

mainly considered suspension levels as performance tolerances (particularly in 16

radiotherapy) whereas equipment may very well fail on safety issues which are 17

covered by the IEC general standards 60601-1 (IEC, 2003b) and associated 18

collateral and particular standards. Many quality assurance manuals refer to the 19

levels triggering such actions as remedial levels. In line with the precedent 20

established in RP 91 (EC, 1997), the main thrust of this publication is concerned with 21

suspension levels. Remedial levels are, on the other hand, well described in 22

numerous quality assurance publications detailing them (AAPM, 2005; IPEM, 2005a, 23

b; AAPM, 2002; EC, 1997, IPEM, 1997a, b, c; et al). 24

Suspension levels are taken as the criteria of acceptability. They must be clearly 25

distinguished from the levels set for acceptance tests. The latter are used to 26

establish that the equipment meets the supplier’s specification or to verify some other 27

contractual issue; they may be quite different from the criteria of acceptability 28

2 Examples of how this might arise include the following: 1.In radiotherapy, a megavoltage unit with poor isocentric accuracy could be restricted to palliative treatment until the unit could be replaced. 2. In nuclear medicine, a rotational gamma camera with inferior isocentric accuracy could be restricted to static examinations. 3. In diagnostic radiology, an x-ray set with the beam limiting device locked in the maximum field of view position might be used to expose films requiring that format in specific circumstances.


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envisaged in the directive. However, it is entirely possible that equipment meeting 1

the requirements of the acceptance test will automatically pass the criteria of 2

acceptability. This is because the acceptance test for modern equipment will often 3

be more demanding than the criterion of acceptability. Tests based on the criteria of 4

acceptability should be performed on installation and thereafter regularly or after 5

major maintenance. 6

In practice, acceptability testing should assure the equipment tested is serviceable 7

and provides acceptable clinical image quality using acceptable patient radiation 8

doses. QA testing may involve additional elements beyond the acceptability and will 9

inevitably involve reporting many remedial levels. It is presumed that by the time 10

acceptability is considered, acceptance tests, compliance with manufacturer’s 11

specifications and commissioning tests have been successfully performed. 12

Equipment may be significantly reconfigured during its useful life arising from 13

updating, major maintenance or changes in its intended use. If this is done, 14

appropriate new acceptability tests will be required. 15

1.4.3. IDENTIFYING AND SELECTING CRITERIA 16

It was not possible to devise a single acceptable approach to proposing values or 17

levels for the criteria selected. Instead a number of approaches, with varying 18

degrees of authority and consensus attaching to them, have been adopted and 19

grouped under headings A to D as follows: 20

Type A Criterion 21

This type of criterion is based on a formal national/international regulation or an 22

international standard. 23

A reasonable case can sometimes be made for using a manufacturer’s specification 24

as a criterion of acceptability. For example, all CE marked equipment, which meets 25

specification, will either meet or exceed the essential safety standards with which the 26

equipment complies. Thus, testing to the manufacturer’s specification could be taken 27

as a means of ensuring the criteria of acceptability are met or exceeded in the area 28

they address. 29


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A case can also be made that compliance with the relevant IEC, CENELEC or 1

national standards might be taken as compliance with criteria that the industry has 2

deemed to be essential for safety. In practice, this approach may be limited in value 3

as the tests required may not be within the competence of end users or service 4

engineers in the field. Thus different agreed approaches to verification will be 5

required. Development in this area is essential to the harmonization referred to 6

above. In particular, agreed methodology is essential in any system of equipment 7

testing. Standards organizations provide a useful role model in this regard, which 8

this publication has tried to emulate.3 9

Type B Criterion 10

This type of criterion is based on formal recommendations of scientific, medical or 11

professional bodies. 12

Where industrial standards are not available or are out of date, advice is often 13

available from professional bodies, notably IPEM, AAPM, NEMA, BIR, ENMS, ACR 14

et al. More detailed advice on testing individual systems is available from the AAPM, 15

earlier IPEM publications and a wide range of material published by many 16

professional bodies and public service organizations. Much of the material is peer 17

reviewed and has been a valuable source where suitable standards are not available. 18

Type C Criterion 19

This type of criterion is based on material published in well established scientific, 20

medical or professional journals. 21

Where neither standards nor material issued by professional bodies are available, 22

the published scientific literature has been consulted and a recommendation from the 23

drafting group has been proposed and submitted to expert review by referees. 24

Where this process led to a consensus, the value has been adopted and is 25

recommended below. 26

3 When equipment standards are developed so that their recommendations can be addressed to and accepted by both “manufacturers and users”, the question of establishing criteria of acceptability becomes much simplified. Highly developed initiatives in this regard have been undertaken in radiotherapy (see IEC 60976 and IEC 60977). These “provide guidance to manufacturers on the needs of radiotherapists in respect of the performance of MEDICAL ELECTRON ACCELERATORS and they provide guidance to USERS wishing to check the manufacturer’s declared performance characteristics, to carry out (footnote continued)


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Type D Criterion 1

The Type D situation arises where it has not been possible to make a 2

recommendation. In a small residue of areas it has not been possible to make 3

recommendations for a variety of reasons. For example, where the technology 4

involved is evolving rapidly, listing a value could be counterproductive. It could 5

become out of date very rapidly or it could act as an inhibitor of development. In 6

such situations we feel the criterion of acceptability should be determined by the 7

institution holding the equipment based on the advice of the MPE or Radiation 8

Protection Adviser (RPA) as appropriate. 9

The criteria of acceptability proposed are identified as belonging to one or another of 10

these categories. In addition, at least one reference to the primary source for the 11

value and the method recommended is provided. Some expansion on the approach 12

and the rationale for the choice is provided, where deemed necessary in an 13

Appendix. Test methods are only fully described if they cannot be referred to in a 14

high quality accessible reference. 15

16

1.5. SPECIAL CONSIDERATIONS, EXCEPTIONS AND EXCLUSIONS 17

1.5.1. SPECIAL CONSIDERATIONS 18

The directive requires that special consideration be given to equipment in the 19

following categories: 20

• Equipment for screening, 21

• Equipment for paediatrics and 22

• High dose equipment, such as that used for CT, interventional radiology, or 23

radiotherapy. 24

acceptance tests and to check periodically the performance throughout the life of the equipment”. This approach has much to offer other areas.


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The chapters and sections in the attached volumes dealing with the high dose group 1

(CT, interventional radiology or radiotherapy), deal comprehensively with this 2

requirement. 3

Equipment used for paediatrics and in screening programmes is often similar or 4

possibly identical to general purpose equipment. Where this is the case, additional 5

guidance for the special problems of paediatrics, such as the requirement for a 6

removable grid in general radiology or fluoroscopy and the special needs with regard 7

to CT exposure programmes are noted in the technology specific sections. The 8

special requirements for mammography are based on those appropriate to screening 9

programmes. 10

1.5.2. EXCEPTIONS 11

Exceptions to the recommended criteria may arise in various circumstances. These 12

include the cases cited in Section 1.2 above, where equipment compliant with safety 13

and performance standards that predate the criteria for acceptability has to be 14

assessed. In such cases, the MPE should make a recommendation to the end user 15

or holder, on whether or not this level of compliance is sufficient to meet the 16

intentions of the directive. These recommendations must take a balanced view of the 17

overall situation, including the economic/social circumstances, older technology etc.; 18

they may be nuanced in that the RPA/MPE may recommend that the equipment be 19

accepted subject to restrictions on its use. Likewise it is always well to remember 20

that acceptability criteria, as already outlined, may depend on the use(s) for which 21

equipment is deployed. 22

1.5.3. RAPIDLY EVOLVING TECHNOLOGIES 23

Medical imaging is an area in which many new developments are occurring. 24

Encouragement of development in such an environment is not well served by the 25

imposition of rigid criteria of acceptability. Such criteria, when rigorously enforced, 26

could become obstacles to development and thereby undermine the functionality and 27

safety they were designed to protect. In such circumstances, the MPE should 28

recommend to the end-user a set of criteria that are framed to be effective with the 29

new technology and that takes account of related longer established technologies, 30


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any IEC/CEN/CENELEC standards available, the manufacturer’s recommendations, 1

the related scientific and professional opinion/published literature and the maxim that 2

the new technology should aspire to be at least as safe as existing technology it is 3

replacing. 4

1.5.4. EXCLUSIONS 5

Within this publication, the term “equipment” has been interpreted to mean the main 6

types of equipment used in diagnostic radiology, nuclear medicine and radiotherapy. 7

This follows the precedent established in RP 91 (EC, 1997). It is important to be 8

aware that the full installation is not treated. Thus, the requirements for an 9

acceptable physical building and shielding that will adequately protect staff, the public 10

and, on occasions, patients; power supplies and ventilation have not been 11

addressed. However, this is an area of growing concern and one in which the 12

requirements have changed considerably as both equipment and legislation have 13

changed. In addition the acceptable solutions to the new problems, arising from both 14

equipment development and legislation, in different parts of the world, are different. 15

Consequently, this area is now in need of focused attention in its own right. 16

Likewise, the contribution of IT networks to improving or compromising equipment 17

functionality can bear on both justification and optimization. This can apply to either 18

PACS or RIS networks in diagnostic radiology and imaging, planning and treatment 19

networks in radiotherapy centres. The requirements for acceptability of such 20

networks are generally beyond the scope of this publication, although they have been 21

included occasionally, for example in radiotherapy, where they are integral to the 22

treatment. 23

As already mentioned elsewhere, the publication focuses on criteria of acceptability 24

and it does not offer advice intended for use in routine Quality Assurance 25

programmes. 26

27

1.6. ESTABLISHING CRITERIA OF ACCEPTABILITY HAVE BEEN MET 28

The criteria of acceptability will be applied by the competent authorities in each 29

member state. The authorities for the MED are generally not the same as those for 30


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the MDD. In addition the criteria will be introduced and applied in the context of the 1

unfolding requirements for clinical audit in healthcare in general and in the 2

radiological world in particular. This is accompanied by a general increase in the 3

requirements for individual and institutional accreditation. Thus the holder of 4

radiological equipment should appoint a competent person to establish that the 5

criteria of acceptability have been met. The person appointed should be an MPE or 6

a person of similar standing. Who performs the tests to verify compliance is a matter 7

for local arrangements. Thus the MPE may choose to perform the tests themselves, 8

write them up, report on them and sign them off. Alternatively, he/she may accept 9

results provided by the manufacturer’s team. These may have been acquired, for 10

example, during acceptance testing or commissioning. Results for tests performed to 11

agreed methodology will be satisfactory in many cases. They provide the information 12

on which the MPE can make a judgement on whether or not the equipment meets 13

the criteria. These two approaches represent the extremes. Most institutions will 14

establish a local practice somewhere between that allows the criteria to be verified 15

with confidence by a suitably qualified agent acting on behalf of the end user. In 16

radiotherapy, joint acceptance testing by the manufacturer’s team and the holder’s 17

MPE is commonplace. Whichever approach is taken, where a suspension level is 18

not met, the outcome and any associated recommendations from the MPE and/or the 19

practitioner must be communicated promptly, in writing, to both the holder and the 20

operators/users of the equipment. 21

In situations where the formally recommended criteria of acceptability are incomplete, 22

lack precision, or where the equipment is very old, subject to exception, special 23

arrangements or exemptions, the judgement and advice of the MPE becomes even 24

more important. Additional, more complete, measurements may be needed to 25

determine the cause of the change in performance. When equipment fails to meet 26

the criteria, agreement must be established on how it will be withdrawn from use with 27

patients. This must be done in association with the MPE whose advice must be 28

obtained. The options, in practice, include those mentioned above and include the 29

possibility of immediate withdrawal, where the failure of compliance is serious 30

enough to warrant it. Alternatively a phased withdrawal or limitations on the range of 31

use of the equipment may be considered. In the latter case, the specific 32

circumstances under which the equipment may continue to be used must be carefully 33


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defined and documented. In addition, the advice of the MPE to the practitioner and/or 1

the holder or the holder’s representative must be made available in a prompt and 2

timely way, consistent with the recommendations for action. 3


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2. DIAGNOSTIC RADIOLOGY 1

The technical parts of Sections 2, 3, and 4 assume those reading and using them are 2

familiar with the introduction and have a good working knowledge of the relevant types of 3

equipment and appropriate testing regimes. 4

2.1. INTRODUCTION 5

Since RP 91 (EC, 1997), there have been a number of major developments in diagnostic 6

radiology. Perhaps the key new developments are the introduction of direct digital detectors 7

(e.g. large area flat panel detectors) for use in radiology and fluoroscopy, as well as multiple 8

slice computed tomography scanners. Both these new developments have implications for 9

acceptability criteria, but suspension levels in these areas are less mature. 10

Manufacturers have also incorporated information technology and other developments into 11

medical imaging systems which have resulted in radiological imaging equipment being 12

more stable. For instance, the stability of the applied tube potential produced by high 13

frequency generators has been much improved when compared with previous x-ray 14

generator designs (e.g. single phase). As equipment performance evolves, so do 15

acceptability criteria. 16

With the implementation of the quality culture within radiology departments and the 17

evolution of quality assurance programmes, criteria have also changed. In part the 18

availability of instrumentation for determination of radiation exposure in radiology linked to 19

computers has also impacted on measurement approaches and quality assurance. 20

However, in rapidly evolving areas of radiology, such as CT scanning, acceptability criteria 21

have not kept pace with technological developments. There is a deficit in consensus based 22

acceptability criteria for these areas of practice which will need to be addressed in the 23

future. Acceptability criteria for all types of diagnostic radiology equipment are summarised 24

in the following sections. 25


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2.2. X-RAY GENERATORS AND EQUIPMENT FOR GENERAL RADIOGRAPHY 1

2.2.1. INTRODUCTION 2

General radiographic systems still provide the great majority of X-Ray examinations. They 3

may be subdivided in practice into a number of subsidiary specialist types of system. This 4

section deals with the Suspension Levels applicable to X-Ray generators, and general 5

radiographic equipment. It also includes or is applicable to mobile systems, traditional 6

conventional tomography and tomosynthesis systems, system subcomponents/devices 7

such as automatic exposure control (AEC), and grids. Much of what is presented here is 8

also applicable to generators for fluoroscopic equipment. However, the criteria have not 9

been developed with specialized X-ray equipment in mind: dental, mammographic, CT and 10

DXA units are mentioned in sections 2.4, 2.5, 2.7, and 2.8. 11

The criteria here refer to X-ray tube and generator, output, filtration and half value layer 12

(HVL), beam alignment, collimation, the grid, AEC, leakage radiation and dosimetry. 13

Suspension/tolerance levels are specified in the Tables below. Before presenting them a 14

few aspects of half value layer and filtration, image quality, paediatric concerns, AEC, 15

mobile devices, and spatial resolution must be mentioned to ensure that the approach and 16

the Tables are interpreted correctly. 17

18 HVL/filtration 19

Total filtration in general radiography should not normally be less than 2.5 mm Al. The half 20

value layer (HVL) is an important metric used as a surrogate measurement for filtration. It 21

shall not be less than the values given in Table 2.1. 22


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Table 2.1 Minimum half-value layer (HVL) requirements 1

Application Values of x-ray tube voltage. (kV)

Minimum permissible (HVL) in mm Al (IEC 60601-1-3 (IEC, 2008a) and see Notes 1 and 2)

General

radiography x-

ray equipment

<50

50

60

70

80

90

100

110

120

>120

See note 3

1.8

2.2

2.5

2.9

3.2

3.6

3.9

4.3

see note 3

Note 1: These HVLs correspond to a total filtration of 2.5 mm Al for equipment operating at constant potential 2 in tungsten anode. 3 Note 2: Linear extrapolation to be used here. 4 Note 3: Test methods differ for different modalities. 5

6

Paediatric Issues 7

Requirements for radiography of paediatric patients differ from those of adults, partly related 8

to differences in size and immobilization during examination (see notes in Tables 9

throughout Section 2). Beam alignment and collimation are particularly important in 10

paediatric radiology, where the whole body, individual organs and their separation distance 11

are smaller. The x-ray generator and tube must have sufficient power to make short 12

exposure times possible. In addition the option to remove the grid from a radiography 13

table/image receptor is essential in a system for paediatric use, as is the capacity to disable 14

the AEC and use manual factors. Systems used with manual exposures (like dedicated 15

mobile units for bedside examinations) should have exposure charts for paediatric patients. 16

17 Image Quality and Spatial Resolution 18

There are unresolved difficulties in determining objective measures of image quality that are 19

both reproducible and reflect clinical performance. Measurements here are limited to high 20


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contrast bar patterns, and may be augmented by subjective or semi subjective 1

assessments at the discretion of the MPE and the Practitioner. (Appendix 1) 2

3

Automatic exposure control for any radiographic detector 4

The AEC should provide limitation of under- and overexposure of the receptor and 5

exposure time. Digital generators also require that pre-programmed exposure systems be 6

assessed to ensure acceptability based on the suppliers’ specification and the MPE’s 7

evaluation. It may also, at the discretion of the MPE, and subject to its being an agreed part 8

of the equipment specification with the supplier, include assessment of Ka,e for a specific 9

type of examination (see Table 2.2 below for radiographic detectors (method in Appendix 10

2). This should be such that the Ka,e for the patient phantom is below an agreed diagnostic 11

reference level (DRL). In addition, the optical density of the film should be between 1.0 and 12

1.5 OD (SBHP-BVZF, 2008). 13

Table 2.2 Examples of image receptor Ka,e for various examinations for some specific 14

conditions see note 1 15

Examination Image receptor entrance air kerma (incl. back scatter) Ka,e (µGy)

PMMA thickness (cm)

Tube voltage (kVp)

Abdomen radiograph adult) 5 20 80 Chest radiograph (adult) 5 11 120 Chest radiograph (child) 5 8 80

16

Note 1: For method see Appendix 2; this also includes some information on CR and DDR. 17

18 19 Mobile devices 20

For mobile devices the criteria for equipment for general radiography are applicable except 21

the requirements for alignment, which cannot be met in practice. 22

23 Conventional tomography 24

The parameters for conventional tomography equipment include cut height level, cut plane 25

incrementation, exposure angle, cut height uniformity and spatial resolution. 26


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2.2.2. CRITERIA FOR X-RAY GENERATORS, AND GENERAL RADIOGRAPHY 1

Table 2.3: Criteria for Acceptability of General Radiography Systems 2

Physical Parameter Suspension Level Reference Type Notes (Paediatrics) Mechanical and electrical safety

If defects pose an immediate mechanical or obvious electrical hazard to patients or staff

IEC 60601 Series

A Mechanical and electrical safety failures can be the source of accidents

X-RAY SYSTEM x-ray tube and generator

tube voltage accuracy A Lower kVp often used in paediatrics (EC, 1996c)

Dial calibration Maximum deviation: > ± 10% or ± 10 kV

EC (1997) IPEM (2005a)

A B

Variation with tube current

Maximum variation: > ± 10%

EC (1997) B

Precision of tube voltage

Deviation > ± 5% from mean

EC (1997) A

x-ray tube output Magnitude of output Y(1m) > 25 µGy/mAs at

80 kV and 2.5 mm Al EC (1997) A

Consistency of output Y within ± 20% of mean EC (1997 ) IPEM (2005a)

B

Consistency of output for range of qualities

Y within ± 20% of mean IPEM (2005a)

B

Half-value layer (HVL ) /total filtration

HVL or sufficient total filtration

HVL in excess for values in Table 8.1

IEC (2008) A Additional Cu filtration 0.1 or 0.2 mm (EC, 1996c) (A)

Exposure time Consistency of exposure time

Actual exposure time > ± 20% of indicated value for values > 100ms

EC (1997) IPEM (2005a)

A B

Consistency and absolute values required for shorter exposures, particularly in paediatrics (EC, 1996c)

Alignment x-ray/light beam alignment

Sum of misalignment in principle directions > 3% of dFID

IPEM (2005a)

B


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Orthogonality of x-ray beam and image receptor (IR)

The angle between central beam axis and IR ≤ 1.5º from 90º

EC (1997) A

Collimation Collimation of x-ray beam

x-ray beam within borders of image receptor

EC (1997) A

Automatic collimation X-ray beam shall not differ by more than 2% of dFID at any side of image receptor Borders within IR

EC (1997) A

Grid A Grids preferably not to be used with children (EC, 1996c)

Grid artefacts No artefacts should be visible

EC (1997) A

Moving grid Lamellae should not be visible on image

EC (1997) A

AEC verification See also Appendix 2 Focal spot (FS) size through assessment of spatial resolution

A Smaller sizes may be required for various applications including paediatrics (EC, 1996c)

Spatial resolution (limited by FS size and detector characteristics)

Spatial resolution ≥ 1.6 lp/mm

JORF (2007a)

B DIN standard

Limitation of overexposure

Maximal focal spot charge < 600 mAs

EC (1997) A Much equipment is non compliant in practice.Should this be modified.

Limitation of exposure time

Maximum exposure time: 6s

EC (1997) A

Consistency of AEC unit

Ka may not differ by more than 10% from mean value

SBPH-BVZ (2008)

B See also Appendix 2

Verification of Ka,e at image receptor for reference examination

See table 2.2. 1.0 < OD >1.5

SBPH-BVZ (2008)


Verification of sensors of AEC

Film density for each sensor may not differ by more than 0.2 OD from mean value

SBPH-BVZ (2008)

B For chest examinations sensors are different on purpose. See also Appendix 2

Verification of AEC at Film density for a SBPH-BVZ B See also Appendix 2


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various phantom thicknesses

phantom thickness differs by more than 0.3 OD from mean value for all thicknesses

(2008)

Verification of AEC at various tube voltages

Film density at a tube voltage may not differ by more than 0.2 OD from mean value for all tube voltages

SBPH-BVZ (2008)


Dose to plate in CR and DDR Systems under AEC

≥ 10 µGy/plate Walsh et al (2008.)

C NOTE: This is double the max normally encountered (3-5 uGy/plate). Grid in position for this measurement.

AEC performance in CR and DDR Systems:

> 50%*

Walsh et al (2008)

C * >50% variation allowed for 5 cm PMMA.

Leakage radiation Leakage radiation Ka(1m) < 1mGy in one

hour at maximum rating EC (1997) A

Dosimetry For KAP meters see 2.6

Image quality Spatial better than 2.8 lp/mm for dose < 10 µGy. And better than 2.4 lp/mm for dose < 5 µGy.

DIN 6868-58 (2001)

B Use phantom described in the standard

Contrast All seven steps are not visible

DIN 6868-58 (2001)

B Use phantom described in the standard

1

2


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Table 2.4: Criteria for Acceptability of Conventional Tomography Systems 1

Physical Parameter Suspension Level Reference Type

Cut height level Difference between indicated and measured

value < 5 mm EC (1997) A

Cut plane incrementation Reproducibility cut height < 2 mm EC (1997) A

Exposure angle Indicated and measured angle should agree

within 5° for angles more than 30°.

Agreement better for smaller angles

EC (1997) A

Cut height uniformity Image should reveal no overlaps,

inconsistencies of exposures, or

asymmetries in motion

EC (1997) A

Spatial resolution Resolution < 1.6 lp/mm EC (1997) A

2

2.3. RADIOGRAPHIC IMAGE RECEPTORS AND VIEWING FACILITIES 3


The Criteria of Acceptability and the related suspension/tolerance levels for X-Ray Films, 5

Screens, Cassettes, CR, DR, Automatic Film Processors, the Dark Room, Light Boxes and 6

the Environment for general radiography are presented in Tables 2.5 to 2.12 below. They 7

do not deal with the requirements for mammography or dental radiography. 8

A wider approach to Quality Assurance of film, film processing and image receptors of all 9

types is a critical part of an overall day to day quality system (IPEM, 2005a; BIR, 2001, 10

IPEM, 1997a; Papp, 1998). Such a system includes commissioning. Detailed 11

commissioning tests are covered in other publications (IPEM, 1997a). 12

There are some fundamental differences between CR and film/screen systems. Proper 13

installation and calibration of a CR system in a radiology department is extremely important. 14

It is also important to note that the x-ray system needs to be properly set up so that it may 15


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be used with CR plates. In particular, the AEC needs to be appropriately set up (Section 1

2.2). 2

Details on desirable specifications and features of CR systems as well as their proper 3

installation can be found in AAPM Report No 93 (2006a). These guidelines should be 4

followed prior to the acceptability testing of CR systems. To date, unlike film systems, there 5

is little guidance on the performance of CR systems, and the suspension/tolerance levels 6

identified will almost inevitably need adjustment in line with future evidence and guidance 7

(Section 1.4). 8

Likewise, with DDR systems, the tube and generator, workstation and /or laser printer must 9

be known to be working properly. When undertaking the QA of the tube and generator, it is 10

advisable to keep the detector out of the beam or protected by lead. As with CR little 11

guidance is available on Suspension/Tolerance levels and the advice given above for CR 12

prevails. Suspension/ tolerance levels suitable for application at the present time are 13

provided in Table 2.7. 14

Display monitors and hardcopy images have a crucial role in the diagnostic process. IPEM 15

notes that inadequacies in the imaging viewing area may serve to negate the benefits of 16

other efforts made to maintain quality and consistency. Modern radiology departments 17

require digital images from many modalities and from PACS systems to be viewed in many 18

locations. Two classes of display are used: diagnostic (systems used for the interpretation 19

of medical images) and review (viewing medical images for purposes other than for 20

providing a medical interpretation). The requirements for each are different. 21


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2.3.2. CRITERIA FOR IMAGE RECEPTORS AND VIEWING FACILITIES 1

Table 2.5 Criteria of Acceptability for Automatic Film Processors, Films, Screens, Darkrooms 2

and Illuminators (mammography excluded) 3

Physical Parameter Suspension Level

Reference Type Notes

Automatic Film Processor:

Base plus Fog OD > 0.3 IPEM (2005a) IPEM (1997a)

B See also IEC 61223-2-1 (1993c), Papp (1988) and EC (1997)

Speed Index 1.2 ± 0.3 IPEM (2005a) BIR (2001) IPEM (1997a)

B See also IEC 61223-2-1 (1993c) and Papp (1988).

Contrast Index 1.0 ± 0.3 IPEM (2005a) BIR (2001) IPEM (1997a)

B See also IEC 61223-2-1 (1993c) and Papp (1988).

Films, Screens, Darkroom and Illuminators:

Screens and Cassettes

Visible artefacts. IPEM (2005a) BIR (2001) IPEM (1997a)

B See also IEC 61223-2-2 (1993d) and EC (1997).

Relative Speed of Intensifying Screens

> 10% or > 0.3 OD across film.

IPEM (2005a) IPEM (1997a)

B See also EC (1997).

Film Screen Contact Non-uniform density or loss of sharpness.

IPEM (1997a) B See also IEC 61223-2-2 (1993d) and EC (1997).

Dark Room Safe Lights and Film fogging

Evidence of film fogging after twice the normal Film Handling Time.

IPEM (2005a) BIR (2001) AAPM (2002)

B See also IEC 61223-2-3 (1993e).

Ambient Lighting > 100 Lux. IPEM (1997a) B See also Papp (1988), EC (1997).

4

5

6

7

8


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Table 2.6 Criteria for Acceptability of Cassettes and Image Plates: 1

Physical Parameter Suspension Level Reference Type Notes Condition of cassettes and image plates

Damage to plate IPEM (2005a) B Suppliers’ recommendations for method

Uniformity Gross non-uniformity Mean ± 20%

IPEM (2005a) B 70kV, 1.0 mm copper at tube head, an exposure for 10µGy, read plate under linear algorithm.

Table 2.7 Criteria for Acceptability of CR readers see notes 1 and 2 2

Physical Parameter Suspension Level Reference Type Notes Dark Noise

Agfa SAL>130 Fuji pixel value > 280 Kodak EIGP > 80 Kodak EIHR > 380 Konica pixel value < 3975

AAPM (2006a)

B Erase plates, leave plates 5 minutes, read under standard conditions. Repeat for all plate sizes.

Linearity and system transfer properties

Manufacturer’s specification

KCARE (2005a) B KCARE CR QA. Establish system transfer properties equation (STP) Dose=f(pixel value)

Erasure cycle efficiency

Blocker visible in second image

IPEM (2005a) B High attenuation material

Exposure index consistency

Indicated exposure does not agree with measured exposure within 20%

KCARE (2005a) B Record detector dose indicator and calculate indicated exposure using the STP equation for all plates

Detector dose indicator consistency

The variation in the calculated indicated exposures differs by greater than 20% between plates for a same exposure

KCARE (2005a) B

Scaling errors > 2% IPEM (2005a) B Blurring Blurring present KCARE (2005a) B Use contact mesh Image quality High Contrast Resolution (Limiting Spatial Resolution)

Spatial resolution better than 2.8 lp/mm for dose < 10 µGy. ≥ 2.4 lp/mm for dose < 5 µGy.

DIN 6868-58 (2001)

A,C Use phantom described in the standard. Also note AAPM, 2006a & Walsh et al. 2008

Contrast All seven steps visible DIN 6868-58 (2001)

A,C Use phantom described in the standard


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Low-Contrast Resolution

Manufacturers specifications

AAPM (2006a)

B Low contrast resolution test object

Laser beam function Edge not continuous the full length of the image

AAPM (2006a)

B Steel ruler

Moiré Patterns Moiré Patterns visible KCARE (2005a) B 70kV, 1.0mm of copper at tube head, grid in place, plate in the bucky at 150cm from the focus

1 2

1. The suspension values quoted for Dark Noise were valid at the time of Publication of this document. 3 However as CR is an evolving technology they are subject to change. 4

2. This is a test that has to be done during the acceptance testing of the CR Reader in order to establish 5 the relationship between receptor dose and pixel value. It tests whether the X-ray generator and the 6 CR reader have been properly set up in order to work together correctly. 7

8


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Table 2.8 Criteria of Acceptability for DDR systems see notes 1, 2 1

Physical Parameter

Suspension Level Reference Type Notes

Dark Noise

Excessive noise in the system

IPEM (2005a ) B Image without exposure or very low exposure

Linearity Manufacturers recommendation

KCARE (2005b) C Establish system transfer properties equation (STP) Dose=f(pixel value)

Image retention Ghosting present KCARE (2005b) C Low exposure with closed collimators and detector covered with lead apron.

Exposure Index Indicated sensitivity indices differ by greater than 20% of equivalent exposure sets.

KCARE (2005b) C 70kV, 1.0 mm copper at tube head, at least three times for 10 µGy. Repeat for 1 µGy and 12 µGy

Uniformity

Mean ± 5% IPEM (2005a) B 70kV, 1.0 mm copper at tube head, 10 µGy.

Scaling errors >2% IPEM (2005a) B Grid, attenuating object of known dimensions or lead ruler

Uniformity of resolution

Blurring present IPEM (2005a) B Use fine wire mesh

Image quality High Contrast Resolution (Limiting Spatial Resolution)

Spatial resolution better than 2.8 lp/mm for dose < 10 µGy. ≥ 2.4 lp/mm for dose < 5 µGy.

DIN 6868-58 (2001)

A,C Use phantom described in the standard. Also note AAPM (2006a) & Walsh et al. (2008)

Contrast All seven steps are visible

DIN 6868-58 (2001)

A,C Use phantom described in the standard

2

1. This test should be done at the acceptance testing of the DDR system in order to establish the 3 relationship between receptor dose and pixel value. This is the relationship between the generator 4 and the detector. 5

2. It should be noted that a number of manufacturers have installed on their DDR equipment automatic 6 QA software in order to carry out a number of QA tests. 7

8

9


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Table 2.9 Criteria of Acceptability for Diagnostic Monitors 1

Physical Parameter Suspension Level Reference Type luminance ratio <200 IPEM (2005a)

AAPM (2006a) B

luminance ratio Black baseline ±35% White baseline ±30%

IPEM (2005a) AAPM (2006a)

B

Distance and angle calibration – distortion (for CRT)

10% IPEM (2005a) RCR (2002) SEFM-SEPR (2002)

B

Resolution Visual inspection low and high contrast resolution different from baseline

IPEM (2005a) AAPM (2006a)

B

DICOM greyscale (GSDF= DICOM Grayscale Standard Display Function)

GSDF ±15% IPEM (2005a) AAPM (2006a)

B

Uniformity >40% IPEM (2005a) AAPM (2006a)

B

Variation between adjacent monitors

>40% IPEM (2005a) AAPM (2006a) RCR (2002)

B

Room illumination >25 lux IPEM (2005a) AAPM (2006a)

B


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Table 2.10 Criteria of Acceptability for Printers 1

Physical Parameter Suspension Level Reference Type Notes Optical density consistency

Baseline ±0.30 IPEM (2005a) BIR (2001) IEC (1994a)

B Note also AAPM (2006a)

Image uniformity >10% IPEM (2005a)

B Note also AAPM (2006a)

2

3

Table 2.11 Criteria of Acceptability for Film Scanners 4

Physical Parameter Suspension Level Reference Type Grayscale >10% Halpern (1995)

Lim (1996) Meeder et al (1995) Seibert (1999) Trueblood (1993) SEFM-SEPR (2002)

C

Image uniformity >10% Halpern (1995) Lim (1996) Meeder et al (1995) Seibert (1999) Trueblood (1993) SEFM-SEPR (2002)

C

Distortion >10% Halpern (1995) Lim (1996) Meeder et al (1995) Seibert (1999) Trueblood (1993) SEFM-SEPR (2002)

C

Spatial resolution Visual inspection low and high contrast spatial resolution different from baseline

Halpern (1995) Lim (1996) Meeder et al (1995) Seibert (1999) SEFM-SEPR (2002)

C

5

6

7

8

9


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Table 2.12 Criteria of Acceptability for Viewing Boxes 1

Physical Parameter Suspension Level Reference Type Notes Luminance < 1000 cd/m2

Mammography < 3,000 cd/m2

> 6,000 cd/m2

IPEM (2005a) B IEC (1993f)

Uniformity >30% Mammography < 30%

IPEM (2005a) B IEC (1993f)

Variation between adjacent viewing boxes

>30% Mammography < 15%

IPEM (2005a) B IEC (1993f)

Room illumination (general radiography)

>150 lux IPEM (2005a) B IEC (1993f)

Room illumination (mammography)

>50 lux CEC (2006) A IEC (1993f)

2

2.4. MAMMOGRAPHY 3


Mammography involves the radiological examination of the breast using x-rays. Mammography is 5

primarily used for the detection of breast cancer at an early stage and is widely used in screening 6

programmes involving healthy populations. It is also used with symptomatic patients. Early 7

detection of breast cancer in a healthy population places particular demands on the radiological 8

equipment as high quality images are required at a low dose. Perhaps because of the exacting 9

demands of mammography, acceptability criteria are particularly well developed (IPEM, 2005b; 10

CEC, 2006). 11

Mammography should be performed on equipment designed and dedicated specifically for imaging 12

breast tissue. Either film/screen or digital detectors may be used. The minimum features of a 13

mammography unit are described in table 2.13. Table 2.14 summarises the acceptability criteria for 14

conventional mammography equipment and 2.15 those for digital units. 15

16

17

18

19


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Table 2.13 Minimum Specification of an X-ray Unit Designed for mammography 1

Aspect Specification

X-ray Tube Nominal Focal Spot Broad focus 0.3 (IEC, 2003a)

Small focus 0.15

AEC (Analogue Equipment) Adjustable or automatically adjusted position

Fine control of optical density

Compression Motorized

Readout of compression thickness

Grid Moving (dedicated mammography)

Focus Film Distance ≥ 60cm

2

2.4.2. MEASUREMENTS 3

Measurements to assess the performance of mammography units should be performed using a 4

series of test equipment, some of which are specifically designed for the purpose. 5

Specific Tests are outlined in the tables below. The purpose of the test and a recommended 6

protocol are cited, together with alternative acceptable protocols. These should form part of a 7

quality system (BSI, 1994). 8

9


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Table 2.14 Film Screen Mammography 1

Physical Parameter Suspension Level Reference Type Notes

Target Film Density OD<1.3 or >2.1 IPEM (2005a) B Not correctable by AEC fine control

AEC Consistency mAs > ±5% Variation in mAs < CEC (2006) A

AEC Thickness Compensation

Maximum deviation in OD ≥ 0.15 from value at 4cm of PMMA or range of ODs > 0.35

CEC (2006) AFFSAPS (2007)

A B

Film/Screen Contact >1 cm² poor contact CEC (2006) A

High Contrast Resolution < 12lp/mm CEC (2006) A

Threshold Contrast > 1.5% 5-6mm CEC (2006) A

X-ray/Film Alignment > 5mm CEC (2006) A

Compression

Maximum Force > 300N 200N not achievable by adjustment of manual control.

CEC (2006)

A

Tube Potential > 2kV difference from set value. IPEM (2005a) B

HVL See Table 2.16 CEC (2006) A

Compression Force Consistency > 20N CEC (2006) A In 30S

2

3

4

5

6

7


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Table 2.15 Digital Mammography Systems 1


AEC Consistency mAs>±5% baseline CEC (2006) A

AEC Thickness Compensation

CNR/PMMA Thickness, with the value at 5cm being used as reference, values at other thicknesses are 2.0cm >115% 4.5cm >103% 3.0cm >110% 5.0cm > 100% 4.0cm >105% 6.0cm > 95% 7.0cm > 90%

CEC (2006) A

Threshold Contrast > 0.85% 5-6mm > 2.35% 0.5mm > 5.45% 0.25mm

CEC (2006) A

X-ray/Film Alignment

>5mm CEC (2006) A

Compression Maximum Force > 300N and 200N not reachable.

IPEM (2005a) CEC (2006)

B A

Tube Potential Accuracy > 2kV difference from set value. IPEM (2005a) B

HVL See Table 2.16 CEC (2006) B

Compression Force Consistency > 20N CEC (2006) A In 30S

2

3

Table 2.16 Typical HVL measurements for different tube voltage and target filter 4

combinations. (Data includes the effect on measured HVL of attenuation by a PMMA 5

compression plate*) (CEC, 2006) 6

HVL (MM Al) for target filter combination

kV Mo +30 µm Mo Mo +25 µm RH RH +25 µm RH W +50 µm RH W +0.45 µm Al

25 0.33 ± 0.2 0.40 ± .02 0.38 ± .02 0.52 ± .03 0.31 ±.03

28 0.36 ± .02 0.42 ± .02 0.43 ± .02 0.54 ± .03 0.37 ±.03

31 0.39 ± .02 0.44 ± .02 0.48 ± .02 0.56 ± .03 0.42 ± .03

34 0.47 ± .02 0.59 ± .03 0.47 ± .03

37 0.50 ± .02 0.51 ± .03

* Some compression paddles are made of Lexan, the HVL values with this type of compression 7

plate are 0.01 mm Al lower compared with the values in the table. 8


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2.5. DENTAL RADIOGRAPHY 1


Dental radiography, though often delivering a low dose, is the most frequently conducted type of x-3

ray examination. This section is applicable to radiographic systems for intra oral radiography using 4

both film and digital detectors. 5

2.5.2. INTRA-ORAL SYSTEMS 6

The following are not acceptable for dental imaging: 7

- Nominal or actual tube voltage < 60kVp for DC and 65-70Kvp for AC equipment 8

- Mechanical timers 9

- Film class lower than E 10

- Focus skin distance for intra oral equipment < 20cm. 11

- Non-rectangular collimators 12

- Systems without audible exposure indication. 13

Material and results of testing dental equipment are available in Gallagher et al. (2008), EC (1997), 14

IEC standards, and the criteria for dental equipment adopted by EU member states (Belsuit van het 15

FANC, 2008; IPEM, 2008; Luxembourg Annexe 7, 2008; JORF, 2007; IEC, 2000a; IPEM, 2005a; 16

Directive R-08-05, 2005; SEFM-SEPR, 2002). 17

Where exposure settings or pre-programmed exposure protocols are provided with the equipment, 18

their appropriateness should be checked as part of the confirmation that the equipment is 19

acceptable. A distinction should be made between exposure settings for adults and children. 20


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2.5.3. CRITERIA FOR DENTAL RADIOGRAPHY 1

Table 2.17 Criteria of Acceptability for Intra-Oral Dental Equipment 2

Physical parameter Suspension level Reference (type) Type Notes

Film development

Developer temperature <18°C and > 40°C IPEM (2005a)

Luxembourg

Annexe 7 (2008)

B Use

Thermometer

Dark room (or desktop

day light processor)

light proof

Gross fog > 0.3 OD IPEM (2005a) B Densitometer

Reproducibility of gross

fog, speed and contrast

Gross fog > 0.3 OD;

IPEM (2005a) B Densitometer;

X-ray tube and generator

Tube voltage accuracy Maximum deviation

± 10%

JORF (2007) A kV meter,

Indication of exposure

time

Difference between

measured exposure

time and baseline >

50%

IPEM (2005a)

EC (1997)

A, B Dosimeter

Consistency of

exposure time

EC (1997) A Dosimeter???

Dosimetry

Incident air kerma for

upper molar tooth

Ka > 4mGy JORF (2007)

Luxembourg

Annexe 7 (2008)

A Measurement

of incident air

kerma at the

tip of the

collimator


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2.5.4. PANORAMIC RADIOGRAPHY 1

This section is applicable to radiographic systems for panoramic dental radiography. 2

Table 2.18 Criteria for Acceptability of OPG Systems 3


Image quality

Characteristics of the

panoramic image

Outside

manufacturer’s

specification

D Follow manufacturer’s

specifications and test

object

Dosimetry

Kerma area product of a

typical clinical exposure or

calculated kerma area

product from dose width

product or equivalent

Deviation > 35% of

indicated PKA value.

JORF

(2007)

A KAP meter or

equivalent dosimeter.

4

2.5.5. CEPHALOMETRY 5

This section is applicable to radiographic systems for cephalometry. 6

In addition, cephalometric systems should: 7

- have X-ray beams collimated to the detector and not larger than 24cmx30cm 8

- have at least a distance of 150cm between focus and skin 9

Table 2.19 Criteria for Acceptability of Cephalometry Systems 10

Physical parameter Suspension level Reference Type Notes

Dosimetry

Kerma area product of a typical

clinical exposure

PKA > 80 mGycm2 JORF (2007)

Luxembourg

Annexe 7

(2008)

A PKA meter or

equivalent

11


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2.6. FLUOROSCOPIC SYSTEMS 1


Fluoroscopic systems can be highly flexible and are open to a wide range of applications. 3

They may offer a multiplicity of modes (and sub-modes) of operation. A representative 4

subset of the most probable intended uses of the equipment should be identified for 5

acceptability testing. For example, the main “cardiac mode(s)” and associated sub-modes 6

might be tested in a unit whose intended application will be in the area of cardiac imaging. 7

If the unit is later deployed for different purposes the need for a new acceptability test will 8

have to be considered by the practitioner and the MPE. 9

In many cases fluoroscopic systems are supplied as dedicated units suitable for cardiac, 10

vascular, gastrointestinal or other specific applications. Powerful mobile units are available 11

and are generally flexible. In all cases the MPE will have to consider the intended 12

application of the unit and the environment in which it will be installed and used. With 13

respect to the X-Ray generator, many of the criteria of acceptability are similar to those 14

prevailing for general radiographic systems. 15


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2.6.2. CRITERIA FOR ACCEPTABILITY OF FLUOROSCOPY EQUIPMENT 1

Table 2.18 Criteria of Acceptability for Fluoroscopy and Fluorography Equipment 2

Physical Parameter Suspension Level Reference Type Notes Mechanical – Safety If defects pose an

immediate mechanical or obvious electrical-shock (hazard to patients or staff)

IEC (2003b) CRCPD (2002)

A 38 cm for fixed fluoro 30 cm for mobile fluoro 20 cm for special surgical fluoro

Collimation Limits Irradiated area > 1.15 × imaged area

IEC (2000b)

A Use radiography

Half-value layer Table 2.1 applies IEC (2000b) A Test methods are modality specific

Patient Air Kerma Rates, and Image receptor input Air Kerma Rates

The four rows BELOW are SENTINEL VALUES offered for consideration

IPEM (2005a, 2002) Martin et al (1998) Dowling et al (2008) O’Connor et al (2008)

C The four rows BELOW are SENTINEL VALUES offered for consideration

“Patient” Entrance Dose Rate, Fluoro Mode: (Image Intensifier and FPD Systems.)

> 50 mGy/min > 100 mGy/min

O’Connor et al (2008) Dowling et al (2008)

C Normal mode smallest field size. 20 cm water or equivalent. Normal mode, any field size. Maximum (lead)

“Patient” Entrance Dose/exposure Digital Acquisition Mode (Image Intensifier and FPD Systems.)

> 2mGy/exposure. Cardiac Systems: > 0.2mGy/exposure


C IPEM and Martin protocols. Largest field size. 20 cm water or equivalent. Normal from survey is 0.03 – 0.12 mGy/exposure)

Detector Entrance Dose Rate, Fluoro mode :(Image Intensifier and FPD Systems).

> 1 µGy/sec in continuous fluoroscopy mode. Cardiac Systems: > 1µGy/sec in continuous fluoroscopy mode.


C 2 µGy/sec quoted in IPEM but not seen in practice. IPEM protocols. Largest field size. Normal mode.

Detector Entrance Dose/exposure Digital Acquisition

> 5µGy/exposure.

O’Connor et al (2008) Dowling et al

C Normal from survey 0.06 – 0.2 µGy/exposure


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Mode :(Image Intensifier and FPD Systems.)

Cardiac Systems: >0.5µGy/exposure.

(2008) IPEM protocols. Largest field size.

Integrated “dose meter” calibration

If absolute accuracy > ±35 %

IEC (2000b)

A

High contrast resolution and focal-spot

Spatial Resolution: < 1 lp/mm. For Cardiac Systems: < 1.2 lp/mm

IPEM (2005a)

B Largest Field Size.

Low contrast detectability

Threshold Contrast: > 4%

IPEM (2005a)

B

Largest Field Size.

Systems or modes of operation controlled by manually setting X-ray factors

Radiographic generator output conditions. As above for High Contrast resolution and low-contrast detectability.

See also Section 2.2

A

Fluoroscopic Timer Acoustic alert is not functional or not continuous until reset.

See also Section 2.2

A

1

2.7. COMPUTED TOMOGRAPHY 2


CT examinations are among the highest dose procedures encountered routinely in 4

diagnostic radiology and account for up to 70 percent of diagnostic medical irradiation. 5

Thus it is important both in terms of individual examinations and population effects. The 6

design and proper functioning, and particularly the optimal use of equipment can 7

substantially influence CT dose. This can be particularly important when pregnant patients 8

or children are involved. CT scanners are under continual technical development resulting 9

in increasing clinical application (Nagel, 2002). In the last two decades the development of 10

helical and multidetector scanning modes allowed greatly enhanced technical abilities and 11

clinical application (Kalender, 2000). 12

CT scanners may be replaced for reasons that, in theory, include poor equipment 13

performance as demonstrated by failure to meet acceptability criteria. In practice it is also 14

likely that replacement may frequently be with a view to meeting increased demands on the 15

service, or to take advantage of new developments which enable improved diagnostics, 16

faster throughput or other clinical benefits. In practice there are few (if any) examples of CT 17


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scanners being removed from use on the basis of their failure to meet currently accepted 1

criteria of acceptability. This suggests that these criteria are ineffective or that 2

obsolescence due to rapid technological development can be an overwhelming 3

consideration in equipment replacement. Arising from these observations it is possible that 4

the available criteria, including those which follow, should be viewed with caution. A review 5

of the dose parameters or dose to patients for certain key procedures, and their comparison 6

to accepted diagnostic reference levels, is a more meaningful measure of the acceptability 7

of the practice using the CT scanner, but this is outside of the scope of the current 8

document. 9

CT scanners are increasingly utilised in radiotherapy in support of treatment planning 10

(Mutic, 2003; IPEM, 1999). They are also a component of PET-CT systems and CT 11

acceptability criteria can be applied to the CT component. 12


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2.7.2. CRITERIA FOR ACCEPTABILITY OF CT SYSTEMS 1

Table 2.19 Criteria of acceptability for CT Equipment see notes 1-3 2

1 Protocols either programmed in lookup table or in written form. 3 2 MPE should compare procedure dose levels with appropriate DRLs 4 3 applicable for equipment manufactured after 2001 5

6

4 Protocols are programmed in lookup table or in written form 5 MPE should compare procedure dose levels with appropriate diagnostic reference levels


CTDI, DLP /CVOL, CW, PK.L,CT

Dose ± 20% of manufacturer's specifications;

IEC (2004a) A

Accessible protocols4 should be consistent with good practice5 ESPECIALLY for paediatrics.

Accuracy of indicated dose parameters

Dose ± 20% indicated dose

A

Image noise Noise ± 25 % of baseline. IPEM (2005a) B

Uniformity ±8 HU

CEC (2006) B

Value recommended in IEC (2004a) is ±4 HU

CT number accuracy

CT number ± 20 HU (water); ± 30 HU (other material) compared to baseline values

IPEM (2005a) A

(French standards are ±4 HU nominal or baseline)

Artefact D

Any artefact likely to impact on clinical diagnosis

Image Display and Printing See section 2.3

Image slice width

+ 0.5 mm for <1 mm ; ±50% for 1 to 2 mm; ± 1mm above 2 mm.

IEC (2004a) A


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2.8. DUAL ENERGY X-RAY ABSORPTIOMETRY 1


Dual-energy X-ray Absorptiometry (DXA) is primarily used in determination of bone mineral 3

density; however its application has more recently been extended to include estimates of 4

body fat content. It is performed on equipment specifically designed for and dedicated to 5

these purposes. Similar examinations are performed on CT with much higher doses 6

(Kalender, 1995). 7

For comparison of scanner results and longitudinal studies the accuracy of calibration is 8

critical. The effect of software updates also needs to be monitored. However there are well 9

documented discrepancies between the results obtained on the scanners of major 10

manufacturers (Kelly, Slovik and Neer, 1989). Further work in this area is essential. 11

2.8.2. ACCEPTABILITY CRITERIA FOR DXA SYSTEMS 12

Table 2.20 Criteria of Acceptability for DXA Equipment 13

14

15

16

Physical Parameter Suspension Level Reference Type Notes Patient Entrance Dose

Less than 500 µGv for spine examination. Outside +/- 50% deviation from manufacturers specified nominal patient dose

Larkin et al (2008) Njeh et al (1999) Sheahan (2005)

C Normal from survey is 20 – 200 µGv) Clinical Protocol – standard. Worst case 35% from Larkin paper and 40% from Sheahan paper.

Repeatability of Exposures

See Section 2.2

BMD accuracy Outside 3% of manufacturer’s specified BMD

Larkin et al (2008) Sheahan (2005) BIR (2001) IAEA (2009) Sheahan et al (2005)

C Standard protocol with supplier’s phantom.


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3. NUCLEAR MEDICINE EQUIPMENT 1




3.1. INTRODUCTION 5

The safe, efficient and efficacious practice of nuclear medicine involves the integration of a 6

number of processes. The quality of each process will have an impact on the overall quality 7

of the clinical procedure and ultimately on the benefit to the patient. It is important, 8

therefore, that each process be conducted within the framework of a quality assurance 9

programme that, if followed, can be shown to achieve the desired objectives with the 10

desired accuracy. 11

The levels of activity in radiopharmaceuticals to be administered clinically are governed 12

primarily by the need to balance the effectiveness and the safety of the medical procedure 13

by choosing the minimum absorbed dose delivered to the patient to achieve the required 14

objective i.e. diagnostic image quality or therapeutic outcome. To realize this goal, it is 15

important to keep in mind that a nuclear medicine procedure consists of several 16

components, all of which must be controlled in order to have an optimal outcome. 17

Although the quality assurance of radiopharmaceuticals is an important process (IAEA, 18

2006), it is not an objective of this section. However, the performance testing of the 19

equipment needed to carry out the quality assurance of radiopharmaceuticals is an 20

objective, both for therapeutic and diagnostic procedures. Devices are included for the 21

determination of administered dose and radiochemical purity such as activity measurement 22

instruments (activity meter or dose calibrator), gamma counter, thin layer chromatography 23

scanner and high performance liquid chromatography radioactivity detector. 24

More specifically the objective of this section is to specify acceptable performance tolerance 25

levels (suspension levels) for the equipment used in Nuclear Medicine procedures, both for 26

gamma camera and positron emission based procedures. In-vitro Nuclear Medicine 27


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diagnostic equipment and instruments are not covered since these do not contribute to the 1

patient exposure. 2

Some Positron Emission Tomography Installations have in-house production of the 3

radiopharmaceuticals they use (e.g. FDG labelled with 18F), utilising either self-shielded 4

cyclotrons or cyclotrons placed in specially designed bunkers. This activity is regarded as a 5

radiopharmaceutical manufacturing activity and therefore is outside the scope of this report. 6

This section also covers the instruments needed for therapeutic procedures and intra-7

operative probes, since these are used directly on the patient to trace the administered 8

radioactivity. 9

When equipment no longer meets the required performance specifications (suspension 10

levels), it should be withdrawn from use, may be disposed of, and replaced (Article 8 (3) of 11

Council Directive 97/43/Euratom). Alternatively, following a documented risk assessment 12

involving the MPE and the Physician, equipment may be used for less demanding tasks for 13

which a lower specification of performance is acceptable. The operator must be advised of 14

the circumstances. 15

The suspension levels stated are intended to assist in the decision making process 16

regarding the need for recalibration, maintenance or removal from use of the equipment 17

considered. 18

This section considers equipment used for: 19

1 Nuclear medicine therapeutic procedures 20

2 Radiopharmacy quality assurance programme 21

3 Gamma camera based diagnostic procedures 22

4 Positron emission diagnostic procedures 23

5 Hybrid diagnostic systems 24

6 Intra-operative probes 25


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Each part of this section is comprised of a brief introduction and a list of relevant equipment. 1

For each piece of equipment, a brief introduction, a table with the critical performance 2

parameters and the suspension levels are given. References to recommended test 3

methods for each parameter are also given. 4

3.2. NUCLEAR MEDICINE THERAPEUTIC PROCEDURES 5


Unsealed radioactive sources are administered to patients orally, intravenously or injected 7

into various parts of the body for curative or palliation purposes. The management of the 8

patient depends on the activity and radionuclide used to give the prescribed absorbed dose. 9

It may be necessary for the patient to be confined into a specially designed room for a few 10

days before being released from the hospital to provide radiation protection to hospital staff 11

and members of the public. 12

When working with unsealed radioactive sources, contamination always presents a 13

potential hazard. Such contamination may come from persons working with the radioactive 14

sources or from patients who have been treated with these substances. Such contamination 15

presents a hazard to anybody coming into contact with it and should be avoided if at all 16

possible, monitored and controlled if it occurs. 17

The patient undergoing treatment with unsealed radioactive sources must also be checked 18

before he/she is released from hospital to determine that the dose rate from his/her body is 19

down to acceptable levels for members of the public. 20

Three types of equipment that are used in Nuclear Medicine therapeutic procedures are 21

considered in this part. These are: 22

• Activity measurement instruments 23

• Contamination monitors 24

• Patient dose rate measuring instruments 25


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3.2.2. ACTIVITY MEASUREMENT INSTRUMENTS 1

Many different radionuclides are used for Nuclear Medicine therapeutic procedures. The 2

amount of activity to be administered to the patient must be determined accurately. Activity 3

measurement instruments, commonly known as Isotope Calibrators or Dose Calibrators, 4

must be capable of measuring the activity of a particular radionuclide (gamma or beta 5

emitting) accurately over a wide range of energies for correct determination of the patient 6

dose. They must also be capable of measuring accurately over a wide range of activities. 7

The performance of activity measurement instruments must be assured through a quality 8

assurance programme conforming to international standards (IEC, 1994c; IEC, 2006). The 9

suspension levels are given in Table 3.1 for each critical parameter together with the type of 10

criterion used and a reference to a recommended test method. 11

Table 3.1 Suspension Levels for Activity Measurement Instruments 12

Physical Parameter Suspension Level Reference Type Background response > 1.5 X Usual

Background IEC (2006) (section 4.1) IEC (1994c) (section 8)

C

Constancy of instrument response

± 10% IEC (2006) (section 4.2) C

Instrument Accuracy ± 10% IEC (1994c) (section 3) C Instrument Linearity ± 10% IEC (2006) (section 4.3)

IEC (1994c) (section 4) C

System reproducibility ± 10% IEC (1994c) (section 5) C Sample volume characteristics ± 15% IEC (1994c) (section 7) C Long-term reproducibility ± 10% IEC (1994c) (section 9) C 13

The suspension levels given in the above table are for instruments used for the 14

measurement of the activity of gamma emitting sources with energies above 100keV. If 15

these instruments are calibrated to measure low gamma ray energies (below 100 keV), 16

beta or alpha emitting sources (Siegel et al, 2004) and the instrument is suspected of 17

malfunctioning then a test with a relevant source needs to be carried out to confirm the 18

suspicion using the values in the above table. 19

3.2.3. CONTAMINATION MONITORS 20

The contamination monitor (also called area survey meter) is designed for the detection and 21

measurement of radioactivity (alpha, beta and gamma) on the surface of objects, clothing, 22


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persons etc. It is used wherever contamination by radioactive substances may be 1

encountered and has to be monitored routinely. 2

The determination of a monitor’s (instrument’s) performance can be at different levels of 3

complexity (ICRU, 1992). A more detailed level is required for the evaluation or type testing 4

of a particular monitor design. Once the monitor has been type tested, less extensive 5

procedures can be used to establish either that a given monitor has maintained its 6

calibration or that it has the same characteristics as the original type tested monitor (IEMA, 7

2004; IPSM, 1994). The complexity of the procedure depends on what information is 8

required and is generally intermediate between that required by a full type test and a simple 9

reproducibility check. 10

The suspension levels are given in Table 3.2 for each critical parameter of contamination 11

monitors together with the type of criterion used and the reference to a recommended test 12

method. 13

Table 3.2 Suspension Levels for Contamination Monitors 14

Physical Parameter Suspension Level Reference Type Sensitivity > 1.2 X Usual Background IEC (2001a) (section 4.2) B Monitor Linearity ± 20% IPSM (1994) (section 3.3)

IEC (2006) (section 4.3) IEC (1994c) (section 4)

B

Statistical Fluctuation of Reading

± 20% IPSM (1994) (section 3.4) B

Monitor Response Time ± 10% IPSM (1994) (section 3.5) B Energy Dependence of Monitor

± 20% IPSM (1994) (section 3.6) B

15

There is a large variation between the different types of contamination monitors. The above 16

suspension levels are a compromise and in some cases may be considered as too 17

conservative. 18

3.2.4. PATIENT DOSE RATE MEASURING INSTRUMENTS 19

A patient who has been administered with a therapeutic amount of activity of a radionuclide 20

becomes a radioactive source and may need to be confined in a specially designed room 21

for a few days before being safe to be released from hospital. The monitoring of the patient 22


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dose rate is very important when gamma radiation is being emitted that can irradiate other 1

persons at a distance from the patient. Therefore, the gamma dose rate of the patient is 2

measured at a standard distance and should be below the acceptable level before the 3

patient is released from hospital. 4

The performance of a patient dose rate measuring instrument must be assured through a 5

continuous quality assurance programme conforming to international standards (IEMA, 6

2004) and other commonly acceptable reports (ICRU, 1992; IPSM, 1994). The suspension 7

levels are given in Table 3.3 for each critical parameter. 8

Table 3.3 Suspension Levels for Patient Dose Rate Measuring Instruments 9

Physical Parameter Suspension Level Reference Type Instrument Dose Rate Linearity

± 20% IPSM (1994) (section 3.3) IEC (2006) (section 4.3) IEC (1994c) (section 4)

C


± 20% IPSM (1994) (section 3.4) C

Instrument Dose Rate Response Time

± 10% IPSM (1994) (section 3.5) C

Energy Dependence of Instrument

± 20% IPSM (1994) (section 3.6) C

10

There is a large variation between the different types of patient dose rate measuring 11

instruments. The above suspension levels are a compromise and in some cases may be 12

considered as too conservative. 13

3.2.5. RADIOPHARMACY QUALITY ASSURANCE PROGRAMME 14

The quality of the radiopharmaceutical administered to the patient has to be such that it will 15

not cause adverse effects to the patient, expose the patient to unnecessary radiation and at 16

the same time be specific for the organ of interest. As the injected radiopharmaceutical 17

circulates in the blood system before it is absorbed and preferentially concentrated in the 18

target organ/tissue, other organs/tissues of the body absorb some of the 19

radiopharmaceutical and therefore receive an absorbed dose related to the amount of 20

radiopharmaceutical. Penetrating radiation from the target organ/tissue also irradiate other 21

organs/tissues. Therefore, the maximum amount administered should not exceed the 22


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recommended local Derived Reference Levels (DRLs). Poor radiochemical purity will also 1

result in radioactivity going to non-target organs and irradiate them unnecessarily. 2

Also different radiopharmaceuticals are used depending on the imaging modality used (PET 3

or SPECT). Furthermore, for a specific examination there may be more than one 4

radiopharmaceutical that can be used to acquire the final image. 5

Taking the above into consideration the administered activity to the patient must be 6

prepared in a specially designed room, the radiopharmacy (also called the Hot Laboratory), 7

under a strictly controlled written procedure. The performance of the instruments used in 8

the preparation must be assured under a quality control programme. 9

The type and number of instruments required in a radiopharmacy will depend on the 10

number of modalities available in a Nuclear Medicine Department and the variety of 11

radiopharmaceuticals and procedures used. For simplicity these are divided into two 12

categories: 13

1. Radiopharmacy for gamma camera based diagnostic procedures 14

2. Radiopharmacy for positron emission based diagnostic procedures 15

In cases were both gamma camera based and positron emission modalities are available, 16

the radiopharmacy will need to have instruments capable for accommodating both types of 17

radiopharmaceuticals, either in a single instrument or different instruments for each type. 18

3.3. RADIOPHARMACY FOR GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES 19


The objective of this part is to define suspension levels for the performance parameters of 21

the equipment needed to carry out the quality assurance programme for 22

radiopharmaceuticals used with gamma camera based modalities. These include devices 23

used for radiochemical purity determination such as the activity measurement instrument, 24

the gamma counter and the thin layer chromatography scanner. 25

The availability of the above equipment in a radiopharmacy depends on the level and 26

sophistication of its activities. 27


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For the protection of the personnel working in a radiopharmacy, instruments such as 1

contamination monitors are also essential. Therefore this part considers the following 2

instruments: 3

• Activity Measurement Instruments 4

• Gamma Counters 5

• Thin Layer Chromatography Scanners 6

• Contamination Monitors 7

3.3.2. ACTIVITY MEASUREMENT INSTRUMENTS 8

The activity measurement instruments that are used for gamma camera based diagnostic 9

procedures need to cover the energy range and activity range of the radiopharmaceuticals 10

that are used in the particular department. The quality assurance programme that must be 11

followed to assure their performance, as well as the suspension levels are the same as 12

those described in section 3.2.2, under “Activity measurement instruments”. 13

3.3.3. GAMMA COUNTERS 14

These are single “well type” gamma counters used in the radiopharmacy to measure the 15

activity (number of counts per second) on the paper chromatography strips used for the 16

radiochemical purity testing of radiopharmaceuticals. These are similar to gamma counters 17

for in-vitro diagnostic investigations and are used to compare the number of counts of the 18

different sections of the paper chromatography strips. 19

The performance of a gamma counter must be assured through a continuous quality 20

assurance programme conforming to international standards (IEC, 2009) and other 21

commonly accepted reports (ICRU, 1992; IPSM, 1994). The suspension levels are given in 22

Table 3.4 for each critical parameter of a well type gamma counter. 23

24

25

26

27


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Table 3.4 Suspension Levels for Well Type Gamma Counters 1

Physical Parameter Suspension Level Reference Type Sensitivity > 1.5 X Usual

Background IEC (2001a) (section 4.2) C

Instrument Dose Rate Linearity

± 20% IPSM (1994) (section 3.3) IEC (2006) (section 4.3) IEC (1994c) (section 4)

C


± 20% IPSM (1994) (section 3.4) C

Instrument Dose Rate Response Time

± 10% IPSM (1994) (section 3.5) C

Energy Dependence of Instrument

± 20% IPSM (1994) (section 3.6) C

Sample Volume Characteristics

± 15% IEC (1994c) (section 7) C

2

The above suspension levels are a compromise and in some cases may be considered as 3

too conservative. 4

Test methods that can be used to monitor a gamma counter are similar to those of patient 5

dose rate measuring instruments. The test method for sensitivity is similar to that of 6

contamination monitors. The test method for volume dependence of the well type gamma 7

counters is similar to that of the activity measurement instruments. 8

3.3.4. THIN LAYER CHROMATOGRAPHY SCANNERS 9

A thin layer chromatography scanner is a gamma counter that simultaneously measures or 10

scans the length of the paper chromatography strip and calculates automatically the count 11

ratio as a measure of radiochemical purity. 12

The suspension levels of each critical parameter of a thin layer chromatography scanner 13

are similar to those of a gamma counter (Table 3.4). 14

3.3.5. CONTAMINATION MONITORS 15

The contamination monitors usually encountered in a radiopharmacy take the form of 16

continuous room monitors for air borne contamination and for the contamination of hands 17

and clothes of the personnel working in the radiopharmacy. The quality assurance 18


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programme that must be followed to assure their performance is the same as that described 1

for contamination monitors (see section 3.2.3). 2

3.4. RADIOPHARMACY FOR POSITRON EMISSION BASED DIAGNOSTIC 3

PROCEDURES 4

The specific radioactivity of the radiopharmaceutical is an important factor to consider in 5

guaranteeing the quality of a PET study (Nakao et al, 2006). Chemical impurities in 6

radiopharmaceuticals, such as precursors and analogues contained in the preparation, may 7

interfere with the PET study (and may cause adverse reactions in the patient). Therefore it 8

is necessary to measure the specific activity and chemical impurities accurately before 9

administration. 10

Due to the very short half-lives of PET radionuclides, quality control is carried out by their 11

producer and they are delivered to the hospital ready for patient administration. 12

The instruments usually found in a hospital PET radiopharmacy are the same as those for 13

gamma camera based diagnostic procedure radiopharmacy (Section 3.3.1), calibrated for 14

the specific PET radionuclides used in a particular hospital. Additionally, in hospital 15

research departments, one may find instruments such as High Performance Liquid 16

Chromatography (HPLC), Gas Chromatography (GC) and Thin Layer Chromatography 17

(TLC) that are used to verify the specific activity, the radiochemical and chemical purity of 18

the radiopharmaceutical used (Dietzel, 2003). There are also all-in-one instrument that 19

perform these analyses at the same time. These analysers need to meet Good 20

Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulation criteria 21

(OECD, FDA) (Dietzel, 2003). 22

Currently there are no commonly acceptable suspension levels for such instruments and 23

therefore the manufacturer’s recommendations for each specific instrument should be used. 24

3.3 GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES 25

3.3.1 INTRODUCTION 26

The gamma camera is currently available in a number of configurations capable not only of 27

performing simple Planar Imaging (Section 3.4.2) but also of Whole Body Imaging (Section 28


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3.4.3) and Single Photon Emission Computed Tomography (SPECT) (Section 3.4.4). Some 1

dual headed Gamma Cameras with appropriate coincidence circuits and software are also 2

capable of performing Positron Emission Tomography (Section 3.4.5). However, the PET 3

Scanner dealt with in section 3.5 is rapidly replacing such systems. 4

The IEC (IEC, 2005c; IEC, 2004b, 1998b, c) and the National Electrical Manufacturers 5

Association (NEMA) (NEMA, 2007a, b) in the USA have published relevant standards. 6

These are almost identical with respect to many test procedures, test objects and 7

radioactive sources and have been used extensively. The IEC and NEMA standards were 8

aimed primarily at manufacturers but are now more orientated towards user application than 9

previous publications making it easier to test for compliance in the field. The NEMA 10

Standard also includes directions for the testing of Gamma Cameras with discrete Pixel 11

Detectors. In this section the suspension levels are mainly related to manufacturer’s 12

specifications, Type A Criteria. The NEMA standards require that the system “meet or 13

exceed” the manufacturer’s specification unless the specification is considered “typical 14

performance”. “Typical” specifications are used when the measurement is sufficiently time-15

consuming that measuring large numbers of units is difficult. For these tests greater 16

suspension levels have been proposed. 17

In addition to the standards, there are a number of publications on quality control that 18

provide a wealth of useful background material and detailed accounts of test methods and 19

phantoms for routine assessment which must be undertaken on a regular basis according 20

to national protocols (IPEM, 2003b; AAPM, 1995). 21

3.4.1. PLANAR GAMMA CAMERA 22

Gamma cameras are normally operated with collimators appropriate to the study being 23

performed. Tests performed with collimators in situ are termed ‘system’ tests. Tests 24

performed without collimators are ‘intrinsic’ tests. Since there is a large range of different 25

types of collimator in use and their characteristics vary from type to type and from 26

manufacturer to manufacturer, professional judgement may have to be called on with 27

respect to system tests for a particular collimator. It is important to perform system non-28

uniformity tests on all collimators in clinical use in order to detect collimator damage at the 29

earliest opportunity (IEC, 2005b) 30


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Table 3.5 Suspension Levels for Planar Gamma Systems 1

Physical Parameter Suspension Level Reference Type Intrinsic Spatial Resolution

>1.05 times the manufacturer’s specification

IEC (2005a), Section 4.5 NEMA (2007a), Sections 2.1 and 2.7

A

Intrinsic Spatial Non-Linearity


IEC (2005a), Section 4.4 NEMA (2007a) Sections 2.2 and 2.7

A

Intrinsic Non-uniformity >1.05 times the manufacturer’s specification


A

Intrinsic energy resolution


IEC (2005a), Section 4.6 NEMA (2007a), Section 2.3

A

Multiple window spatial registration



A

Intrinsic count rate performance in air

<0.9 times the manufacturer’s specification

NEMA (2007a), Section 2.6 A

System Spatial Resolution with scatter



A

System Non-uniformity >1.05 times the manufacturer’s specification

IEC (2005a), Section 4.5 A

2

3.4.2. WHOLE BODY IMAGING SYSTEM 3

The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a) 4

contain a limited number of tests for Whole Body Systems. Before performing these specific 5

tests, it is advisable that the basic tests for the Planar Gamma Camera are performed for 6

each detector head used for whole body imaging (Table 3.5). 7

8

9

10

11

12

13


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Table 3.6 Suspension Levels for Whole Body Imaging Systems 1

Physical Parameter Suspension Level Reference Type Whole body non-uniformity

>10% difference between this and planar system uniformity

IPEM (2003b) Section 4.2.1 B

Whole Body Spatial Resolution Without Scatter


IEC (1998c), Section 3.2 NEMA (2007a), Section 5.1

A

Scanning constancy Any deviation in mean count rate greater than expected from Poisson statistics

IEC (1998c), Section 3.1 A

2

3.4.3. SPECT SYSTEM 3

The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a) 4

both contain a section devoted to SPECT systems. The basic tests for Planar Gamma 5

Camera systems should be performed on each detector head used for SPECT before 6

commencing with the tests specific for SPECT. 7


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Table 3.7 Suspension Levels for SPECT Systems 1

Physical Parameter Suspension Level Reference Type Centre of Rotation (COR) and Detector Head Tilt

COR X axis offset: >1.05 times the manufacturer’s specification For Multiple head systems offsets >5% Mismatch Y axis >5% between detectors

IEC (2004d), (1998b), Sections 3.1.1 and 3.1.2 NEMA (2007a), Section 4.1 IAEA (2007c) Section 4.3.3 IPEM (2003b) Section 5.3.2

A

Collimator Hole Misalignment


IEC (2004d), (1998b), Section 3.2 IAEA (2007c), Section 3.3.6 IPEM (2003b) Section 5.3.3

A

SPECT System Spatial Resolution


IEC (2004d), (1998b), Section 3.6 NEMA (2007a), Section 4.3

A

Detector to Detector Sensitivity Variation


NEMA (2007a), Section 4.5 A

Variation of Response with Detector Rotation

≥1.5% AAPM (1995), Section III.A.1 IPEM (2003b) Section 5.3.7

A

2

3.4.4. GAMMA CAMERAS USED FOR COINCIDENCE IMAGING 3

The basic tests for Planar Gamma Camera Systems should be performed on each detector 4

(Table 3.5). However, the thicker crystals required for these cameras do not perform as well 5

with respect to intrinsic spatial resolution as the thinner crystals intended mainly for use with 6

technetium-99m based radiopharmaceuticals (Table 3.8). Tolerances for the other tests are 7

the same as those in Table 3.6. 8

9

10

11

12

13

14

15

16


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Table 3.8 Suspension Levels for Coincidence Gamma Camera Systems 1

Physical Parameter Suspension Level Reference Type Intrinsic Spatial Resolution

>1.05 times the manufacturer’s specification [A]


A

System Spatial Resolution

>1.05 times the manufacturer’s specification [A]

IEC (2005a), Section 4.3 NEMA (2007), Section 3.2

A

2

3.5. POSITRON EMISSION DIAGNOSTIC PROCEDURES 3


Positron Emission Tomography (PET) is a nuclear medicine imaging technique that utilises 5

positron-emitting radionuclides, normally produced in a cyclotron. The most frequent clinical 6

indication for a PET scan today is in the diagnosis, staging, and monitoring of malignant 7

tumours. Other indications include assessment of neurological and cardiological disorders. 8

The PET technology has evolved rapidly in the past decade. Two significant advances have 9

greatly improved the accuracy of PET imaging: 10

(i) the introduction of faster scintillation crystals and electronics which permit higher 11

data acquisition rates, and, 12

(ii) the combination, in a single unit, of PET and CT scanners (“hybrid” scanners, see 13

section 3.6). 14

It is expected that the utilisation of PET will increase dramatically in the future. In some 15

cases it may substitute for current nuclear medicine investigations but, in general, PET will 16

be complementary to the use of single photon imaging with the gamma camera. 17

The purpose of this section is to specify Suspension levels for PET scanners to be used in 18

clinical imaging. Note that these technical requirements relate to clinical facilities and are 19

not intended to apply to research installations. 20


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3.5.2. POSITRON EMISSION TOMOGRAPHY SYSTEM 1

PET is based on the coincidence detection of two oppositely directed 511 keV photons 2

emitted from the annihilation of a positron with an atomic electron in vivo. The detection of 3

such events, known as true coincidences, is used for the reconstruction of an image 4

describing the in vivo distribution of a positron emitting radiopharmaceutical. Apart from 5

these events, there are also other types of erroneous coincidences that may be detected, 6

namely scattered and random coincidences. Scattered coincidences are events formed by 7

detection of two annihilation photons, where at least one has undergone Compton 8

scattering before detection (but still are detected in the energy window), while random 9

coincidences are formed when two photons originating from two different annihilation sites 10

are detected within the system’s coincidence time window. 11

The performance of PET systems must be assured through a continuous quality assurance 12

programme conforming to international standards (IEC, 2008c; NEMA, 2007b; IEC, 2005) 13

and other commonly accepted reports (IAEA, 2009). The suspension levels are based on 14

Type A Criteria. These are given in Table 3.9 for each critical parameter of PET systems. 15


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Table 3.9 Suspension Levels for PET Systems 1

Physical Parameter Suspension Level Reference Type Spatial Resolution FWHMobserved

>1.05*FWHMexpected NEMA (2007b) (section 3.3) A

Sensitivity STOT observed < 0.95*STOT expected

NEMA (2007b) (section 5.3) IEC (2008d) (section 3.3) IEC (2005b) (section 4.2)

A

Energy resolution REobserved > 1.05*REexpected IAEA (2007c) (section 4.1.4)

A

Scatter fraction, count losses and random measurements

NECobserved <NEC Recommended SFobserved > 1.05*SFexpected

NEMA (2007b) (section 4.3) IEC (2008d) (section 3.6) IAEA (2007c) (section 4.1.3)

A A

Uniformity %NUobserved > 1.05*%NUexpected

NEMA (2007b) (section 7.3) A

Image quality and accuracy of attenuation and scatter correction

Unacceptable visual assessment

IAEA (2007c) (section 5.1.4)

A

Coincidence timing resolution (TOF)

RTobserved > 1.05*RTexpected IAEA (2007c) (section 4.1.6)

A

Mechanical Tests If any mechanical part is found to compromise the safety of operation

C

* Expected and recommended values are the values for each parameter measured or agreed 2 during the acceptance testing. 3 FWHM = Full Width at Half Maximum 4

3.5.3. HYBRID DIAGNOSTIC SYSTEMS 5

A hybrid diagnostic system is defined as the combination of two diagnostic modalities into 6

one system. Examples of such systems are PET-CT, SPECT-CT, PET-MRI, etc. Usually 7

one modality presents functional (molecular) images and the other anatomic images. The 8

fusion (combination) of their images gives a higher diagnostic value than the individual 9

images alone. 10

The quality control procedures of each individual modality comprising the hybrid system are 11

well established and if followed as recommended, the hybrid system will operate optimally. 12

The suspension levels for the individual modalities are valid for the hybrid systems as well. 13

The only concern with hybrid systems even today, is the alignment of the imaging 14

modalities of the hybrid system. Here it is recommended that an independent alignment 15


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test, using a phantom in the place of a patient, be used at regular intervals to assure the 1

alignment of the modalities comprising the hybrid system (NEMA, 2007b; Nookala, 2001). 2

The suspension level is based on Type C Criteria and is given in Table 3.10 for the 3

alignment of a hybrid system. 4

Table 3.10 Suspension Level for the Alignment of Hybrid Systems 5

Physical Parameter Suspension Level Reference TypeAlignment Test of a Hybrid System

> ± 1 pixel or ± 1 mm, whichever is bigger

Nookala (2001)

C

6

3.4 INTRA-OPERATIVE PROBES 7

Radiotracer techniques using intra-operative gamma probes are procedures that surgeons 8

can use to more easily localise small tumours or lymph nodes to be removed in a surgical 9

procedure. Use of intra-operative probes decreases operating time, decreases patient 10

morbidity and improves staging accuracy. All of these can lead to improved treatment, 11

improved quality of life and higher long-term survival rates (Halkar and Aarsvold, 1999). 12

The most established type of intra-operative probe is the non-imaging gamma probe. Other 13

types such as imaging intra-operative probes and beta probes are less well established or 14

are still under development and therefore their performance parameters are less rigorously 15

defined. Furthermore a wide range of gamma probe systems are commercially available 16

with different detector material, detector sizes and collimator abilities. Various methods of 17

evaluation of such equipment have been proposed (NEMA, 2004; IEC, 2001a). For these 18

reasons suspension levels to cover all the types of intra-operative probes do not exist. 19

For the most common application, that of the detection of the sentinel lymph node (SLN), 20

minimum requirements of a gamma probe system has been recommended (Wengenmair 21

and Kopp, 2005; Yu et al, 2005). These were derived mainly from comparison studies of 22

commercially available probe systems and are presented in Table 3.11. It is recommended 23

that the user of a particular probe system establish a quality assurance system for the 24

probe system in use and establish suspension levels taking into account the manufacturer’s 25

recommendations. 26


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Table 3.11 Suspension Levels for a SLN intra-operative gamma probe system 1

Physical Parameter

Suspension Level Reference Type

Radial Sensitivity (far field)

FWHM > 40o Wengenmair and Kopp (2005) NEMA (2004) (section 3.9)

C

Spatial Resolution FWHM >15mm for lymph nodes in head, neck and supraclavicular region FWHM > 20mm for lymph nodes in extremities, axilla and groin

Wengenmair and Kopp (2005) NEMA (2004) (section 3.5)

C

Sensitivity < 5.5 cps/kBq Wengenmair and Kopp (2005) NEMA (2004) (section 3.1 – 3.4)

C

Shielding > 0,1 of minimum system sensitivity

Wengenmair and Kopp (2005) C

2


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4 RADIOTHERAPY 1




3.6. INTRODUCTION 5

The purpose of this document is to list performance parameters and their tolerances. 6

Specific reference is not made to safety requirements, but these need to be checked at 7

acceptance and after maintenance and upgrades and may result in suspension of the 8

equipment during operation, if not met. 9

These functional performance tolerances reflect the need for precision in radiotherapy and 10

the knowledge of what can be reliably achieved with radiotherapy equipment. The 11

tolerances presented must be used as suspension levels at which investigation must be 12

initiated, according to the definition in section 1.4.2. Where possible, it will be necessary to 13

adjust the equipment to bring the performance back within tolerance limits. If adjustment is 14

not possible, e.g. loss of isocentric accuracy, it may still be justified to use the equipment 15

clinically for less demanding treatments. Such a decision can only be taken after careful 16

consideration by the clinical team (responsible medical physics expert and radiation 17

oncologist) and must be documented as part of an agreed hospital policy. Alternatively it 18

should be suspended from use until performance is restored. Suspension from use can also 19

be required if the safety requirements in the relevant safety standards are not met. 20

In the following clauses these levels are referred to as performance tolerance levels, as this 21

is the terminology used in the quoted IEC standards. However, in the tables these levels 22

are listed as tolerance/suspension levels as they correspond also with the definition of 23

suspension level in section 1.4.2 and used in the other sections of this document. 24

The performance tolerance/suspension levels quoted in this section have been extracted 25

mostly from international and national standards (category type A), supplemented by 26

guidance from national professional bodies (category type B) (see section 1.4.3). 27

Tolerances are expressed in the same format (e.g. ± or maximum deviation) as originally 28

given in the quoted standards and guidance documents. 29


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All test equipment used in measuring functional performance must be well maintained, 1

regularly calibrated and traceable (where appropriate) to national standard laboratories. 2

3.3 LINEAR ACCELERATORS 3

IEC 60601-2-1 (1998a) is the standard which identifies those features of design that are 4

regarded as essential for the safe operation of the equipment and places limits on the 5

degradation on the performance beyond which a fault condition exists. These include 6

protection against electrical and mechanical hazards and unwanted and excessive radiation 7

hazards (i.e. dose monitoring systems, selection and display of treatment related 8

parameters, leakage radiation and stray radiation). 9

IEC 60976 (2007) and IEC 60977 (2008c) are closely related to this standard. The former 10

specifies test methods and reporting formats for performance tests of medical electron 11

accelerators for use in radiotherapy, with the aim of providing uniform methods of doing so. 12

The latter is not a standard per se but suggests performance values, measured by the 13

methods specified in IEC 60976 (2007) that are achievable with present technology. 14

The values given in Table 4.1 are a summary of the tolerance values in IEC 60977 (2008c) 15

and are based on the methodology in IEC 60976 (2007). These values are broadly 16

consistent with the tolerances previously specified in IPEM 81 (1999), AAPM Report 46 17

(1994) and CAPCA standards (2005a). For a detailed description of test methods and 18

conditions, please refer to the IEC and IPEM documents. A list of suggested test equipment 19

is included in IEC 60977 (2008c). The table is intended to include the performance 20

parameters of all treatment devices incorporating a linear accelerator. All tests form part of 21

acceptance testing. Where tests are performed routinely for quality control, suggested 22

frequencies of testing are given in IEC 60977 (2008c), IPEM 81 (1999), AAPM Report 46 23

(1994), CAPCA standards (2005a) and other national QA protocols. 24

In the table, “IEC” refers to IEC 60976 (2007) and 60977 (2008c) and the numbers in the 25

Reference column refer to the clauses in these publications. “IPEM (1999)” refers to tables 26

in its section 5.2. 27


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Table 4.1 Summary of functional performance characteristics with tolerance/suspension 1

values for acceptance testing and quality control of a medical electron accelerator 2

Physical Parameter Tolerance/ Suspension

Level

Reference (IEC (2007,

2008c) unless stated)

Type

Uniformity of radiation fields 9 X-ray beams

Beam flatness in flattened area (max/min ratio)

1.06 (see also IEC)

A

Beam symmetry (max/min ratio) 1.03 A Dependence on gantry and collimator angle

See IEC A

Beam flatness at dmax See IEC A Wedge fields

Maximum deviation of wedge factor

2 % IPEM (1999) B

Maximum deviation of wedge factor with gantry angle

3 % IPEM (1999) B

Maximum deviation of wedge angle

2° A

IMRT See IEC A Electron beams

Beam flatness See IEC A Dependence of flatness on gantry and collimator angle

3 % A

Beam symmetry (max/min ratio) 1.05 A Maximum surface dose (max/min ratio)

1.09 See IEC A

Dose monitoring system 7 Calibration check 2 % A Reproducibility 0.5 % Proportionality 2 % IPEM (1999) 1% A, B Dependence on angular position 2 % IPEM (1999) B Dependence on gantry rotation 2 % A Stability of calibration within day 2 % A Stability in moving beam radiotherapy See IEC A Depth dose characteristics See IEC 8 A X-ray beams

Penetrative quality 2 % IPEM (1999) B Depth dose and profile 2 % IPEM (1999) B

Electron beams A Minimum depth of dmax 1 mm A Practical range to 80% ratio 1.6 A Penetrative quality 3 % or 2 mm A


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Maximum relative surface dose 100 % A Stability of penetrative quality 1 % or 2 mm

Indication of radiation fields 10 X-ray beams A

Numerical field indication 3 mm or 1.5 % See also IEC

A

For MLCs 3 mm or 1.5 % See IEC

A

Light field indication 2 mm or 1 % See also IEC

A

Centres of radiation field and light field

2 mm or 1 % See also IEC

A

For MLCs 2 mm or 1 % See also IEC

A

For SRS/SRT 0.5 mm See also IEC

A

Reproducibility 2 mm SRS alignments 0.5 mm

See IEC See also IPEM (1999)

A, B

Electron beams Light field indication 2 mm A

Collimator geometry Parallelism of opposing edges 0.5° A Orthogonality of adjacent edges 0.5° A Beam centring with beam limiting system rotation

2 mm A

Light field Field size (10*10 cm2) 2 mm IPEM (1999) B Illuminance (minimum) 25 lux A Edge contrast ratio (minimum) 4.0 A

Indication of the radiation beam axis 11 On entry

X-rays 2 mm A Electrons 4 mm A SRS 0.5 mm A

On exit X-rays 3 mm A SRS 0.5 mm A

Isocentre 12 Radiation beam axis 2 mm IPEM (1999) 1

mm A, B

Mechanical isocentre 1 mm IPEM (1999) B Indication 2 mm

SRS 0.5 mm IPEM (1999) B Distance indication 13 Isocentric equipment 2 mm IPEM (1999) A, B


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3mm Non-isocentric equipment 5 mm A Zero position of rotational scales 14 Gantry rotation 0.5° IPEM (1999) B Roll and pitch of radiation head 0.1° A Rotation of beam limiting system 0.5° IPEM (1999) B Isocentric rotation of the patient support 0.5° A Table top rotation, pitch and roll 0.5° A Accuracy of rotation scales 1° IPEM (1999) B Congruence of opposed radiation fields 1 mm 15 Movements of patient support 16 Vertical movements 2 mm A Longitudinal and lateral movements 2 mm IPEM (1999) B Isocentric rotation axis 1 mm A Parallelism of rotational axes 0.5° A Longitudinal rigidity 5 mm A Lateral rigidity 0.5° and 5 mm A Electronic imaging devices 17 Minimum detector frame time 0.5 s A Corresponding maximum frame rate 2 / s A Minimum signal-to-noise ratio 50 A Maximum imager lag

Second to first frame 5 % A Or fifth to first frame 0.3 % A

Minimum spatial resolution 0.6 lp/mm IPEM (1999) B 1

Detachable devices can be attached to either the treatment head or the couch. The former 2

include shadow trays and micro-MLCs, and the latter include devices such as stereotactic 3

frames, head shells, bite-blocks, etc. Where reproducible immobilisation and positioning of 4

the patient is required, the positional tolerance of these devices should be 2 mm in general 5

use and 0.5 mm for SRS. 6

3.7. SIMULATORS 7

IEC 60601-2-29 (2008b) is the standard which identifies those features of design that are 8




hazards. In a similar way to IEC 60976 (2007) and 60977 (2008c) for linear accelerators, 12

IEC 61168 (1993a) and IEC 61170 (1993b) specify test methods and functional 13


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performance values for radiotherapy simulators. The functional performance requirements 1

of radiotherapy simulators are directly related to the radiotherapy equipment being 2

simulated. The performance tolerances must therefore be at least equal to those 3

considered appropriate for the radiotherapy equipment and in many instances must be 4

better in order not to add to the total positioning errors. There are some differences from 5

recommendations published by national physicists’ associations (IPEM (1999), AAPM 6

(1994) and CAPCA standards (2005b). Where recommendations from these bodies are 7

adopted they are indicated in the table 8

The values given in Table 4.2 are a summary of the tolerance values in IEC 61170 (1993b) 9

and are based on the methodology in IEC 61168 (1993a). Where additional tolerances (e.g. 10

for MLC and SRS/SRT simulation) have been suggested in the more recent linear 11

accelerator standards IEC 60976 (2007) and 60977 (2008c) and IPEM (1999), these are 12

indicated in the table. For a detailed description of test methods and conditions, please refer 13

to the IEC and IPEM documents. 14

All tests form part of acceptance testing. Where tests are performed routinely for quality 15

control, suggested frequencies of testing are given in IEC 61170 (1993b), IPEM (1999), 16

AAPM (1994), CAPCA (2005b) standards and other national QA protocols. 17

In the table, “IEC” refers to IEC 61168 (1993a) and 61170 (1993b). 18


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values for acceptance testing and quality control of a radiotherapy simulator 2


Level

Reference (IEC (1993a,b) unless stated)

Type

Indication of radiation fields Numerical field indication 2 mm or 1.0 %

See also IEC IPEM (1999)

A, B

For MLCs 2 mm or 1.0 % IEC (2008c, 2007)

A

Light field indication 1 mm or 0.5 % See also IEC

A

Centres of radiation field and light field

1 mm or 0.5 % See also IEC

IPEM (1999) A, B

For MLCs 1 mm or 0.5 % IEC (2008c, 2007)

A

For SRS/SRT 0.5 mm IEC (2008c, 2007)

A

Reproducibility 1 mm A SRS alignments 0.5 mm IEC (2008c,

2007) IPEM (1999)

A, B

Delineator geometry Parallelism of opposing edges 0.5° A Orthogonality of adjacent edges 0.5° A Beam centring with beam limiting system rotation

2 mm IEC (2008c, 2007)

A

Light field Field size (10*10 cm2) 1 mm A Minimum illuminance 50 lux A Minimum edge contrast ratio 4.0 A

Indication of the radiation beam axis On entry 1 mm IPEM (1999) B

SRS 0.5 mm IEC (2008c, 2007)

A

On exit 2 mm A SRS 0.5 mm IEC (2008c,

2007) A

Isocentre Radiation beam axis 1 mm

See also IEC IPEM (1999) A, B

Mechanical isocentre 1 mm IPEM (1999) B Indication 1 mm IPEM (1999) B

SRS 0.5 mm IPEM (1999) B Distance indication From isocentre 1 mm A


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From radiation source 2 mm A Image receptor to isocentre 2 mm A Zero position of rotational scales Gantry rotation 0.5° IPEM (1999) B Roll and pitch of radiation head 0.1° IEC (2008c) A Rotation of delineator 0.5° IPEM (1999) B Isocentric rotation of the patient support 0.5° IEC (2008c) A Table top rotation, pitch and roll 0.5° IEC(2008c) A Accuracy of rotation scales 1° IPEM (1999) B Congruence of opposed radiation fields 1 mm Movements of patient support Vertical movements 2 mm A Longitudinal and lateral movements 2 mm IPEM (1999) B Isocentric rotation axis 1 mm A Parallelism of rotational axes 0.5° A Longitudinal rigidity 5 mm A Lateral rigidity 0.5° and 5 mm A Electronic imaging devices Minimum detector frame time 0.5 s IEC (2008c,

2007) A

Corresponding maximum frame rate 2 / s IEC (2008c, 2007)

A

Minimum signal-to-noise ratio 50 IEC (2008c, 2007)

A

Maximum imager lag Second to first frame 5 % IEC (2008c,

2007) A

Or fifth to first frame 0.3 % IEC (2008c, 2007)

A

Minimum spatial resolution 0.6 lp/mm IPEM (1999) 10.2.6

B

Radiographic QC Alignment of broad and fine foci images 0.5 mm IPEM (1999) B Fluoroscopic QC Full radiographic and fluoroscopic tests IPEM (1999) B Alignment of Shadow Trays 1 mm IPEM (1999) B

1

3.8. CT SIMULATORS 2

CT simulators usually comprise a wide bore CT scanner, together with an external patient 3

positioning and marking mechanism using projected laser lines to indicate the treatment 4

isocentre. This is often termed “virtual simulation”. Since this is an application of CT 5

scanning, there is no international standard. However quality assurance of the scanner and 6


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alignment system is essential to ensure that the isocentre is accurately located in the 1

treatment volume for subsequent treatment planning and treatment. The established 2

standards for CT scanners (see section 2.7) for good image quality and optimum patient 3

radiation dose apply. Acceptable quality assurance regimes are therefore based upon good 4

clinical practice. The most recent work is “Quality assurance for computed-tomography 5

simulators and the computed-tomography-simulation process”: (AAPM, 2003). The 6

tolerance limits in this report are designed to satisfy the accuracy requirements for 7

conformal radiotherapy and have been shown to be achievable in a routine clinical setting. 8

Further guidance is contained in IPEM Report 81 published in 1999. The guidance in Table 9

4.3 is based on these two reports. IPEM Report 81 suggests that the tests are done under 10

the same scanning conditions as those used clinically. Checks on image quality should 11

also be done after software upgrades in case they affect the calibration of the Hounsfield 12

Units. All tests form part of acceptance testing. Where tests are performed routinely for 13

quality control, suggested frequencies of testing are given in AAPM Report 83 (2003), IPEM 14

(1999), CAPCA (2007b) standards and other national QA protocols. 15

16


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values for acceptance testing and quality control of CT simulators 2


Level

Reference (AAPM,2003) unless stated)

Type

Alignment of CT Gantry Lasers

With centre of the imaging plane ± 2 mm B

Parallel & orthogonal over length of laser projection

± 2 mm B

Alignment of Wall Lasers

Distance to scan plane ± 2 mm B

With imaging plane over length of laser projection

± 2 mm IPEM (1999) 1° B

Alignment of Ceiling Laser

Orthogonal with imaging plane ± 2 mm B

Orientation of Scanner Table Top

Orthogonal to imaging plane ± 2 mm B

Scales and Movements

Readout of longitudinal position of table top

± 1 mm IPEM (1999) 1 mm B

Table top indexing under scanner control ± 1 mm B

Readout of gantry tilt accuracy ± 1° B

Gantry tilt position accuracy ± 1° B

Scan Position

Scan position from pilot images ± 1 mm IPEM (1999) 1 mm B

Image Quality

Left & right registration None IPEM (1999) B

Image scaling 2 mm IPEM (1999) B

CT number/electron density verification ± 5 HU water B


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± 10 HU air ± 20 HU lung, bone

1

3.9. COBALT-60 UNITS 2

IEC 60601-2-11 (2004b) is the standard which identifies those features of design that are 3




hazards (i.e. controlling timer, selection and display of treatment related parameters, 7

leakage radiation and stray radiation). IEC 60601-2-11 (2004b) also includes requirements 8

for multi-source stereotactic radiotherapy equipment. 9

The IEC has not published performance tolerances for cobalt-60 units. The functional 10

performance characteristics and tolerance values in Table 4.4 are based on those for linear 11

accelerators in IEC 60976/7 (2008c, 2007) with some changes for cobalt-60 units. The table 12

does not address multi-source stereotactic radiotherapy equipment. There are some 13

differences from recommendations published by national physicists’ associations (IPEM 14

(1999), AAPM (1994) and CAPCA (2006a) standards). Where recommendations from 15

these bodies are adopted, they are indicated in the table. For a detailed description of test 16

methods and conditions, please refer to the documents indicated. 17


control, suggested frequencies of testing are given in IPEM (1999), AAPM (1994), CAPCA 19

(2006a) standards and other national QA protocols. 20


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values for acceptance testing and quality control of cobalt-60 units 2

Physical Parameter Tolerance/ Suspension Level

Reference (IEC (2008c)

unless stated)

Type

Uniformity of radiation fields Beam flatness ± 3 % A Beam symmetry ± 2 % IPEM (1999) B Dependence on gantry and collimator angle

See IEC 60976/7 A

Wedge fields Maximum deviation of wedge factor

2 % IPEM (1999) B

Maximum deviation of wedge angle

2° A

Source position (when applicable) 3 mm AAPM (1994) B Controlling Timer and Output Checks

Timer check on dual timer difference 1 s IPEM (1999) B Calibration check 2 % A Reproducibility 0.5 % A Proportionality 2 % A Dependence on gantry rotation 1 % IPEM (1999) B Stability in moving beam radiotherapy See IEC 60976/7 IEC 2007, 2008C, Timer linearity 1 % AAPM (1994) B Stability of timer ± 0.01 min A Output vs field size 2 % IPEM (1999)

AAPM (1994) B

Shutter correction 2 % IPEM (1999) B Depth dose characteristics Penetrative quality 1 % IPEM (1999) B Depth dose and profile 2 % IPEM (1999) B Indication of radiation fields Numerical field indication 3 mm or 1.5 % IPEM (1999) 2 mm A, B Light field indication 2 mm or 1 % Centres of radiation field and light field 2 mm or 1 % AAPM (1994) 3

mm A, B

Reproducibility 2 mm A Collimator geometry

Parallelism of opposing edges 0.5° A Orthogonality of adjacent edges 0.5° A Beam centring with beam limiting system rotation

2 mm A

Light field Field size (10*10 cm2) 2 mm IPEM (1999) B


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Minimum illuminance 25 lux A

Minimum edge contrast ratio 4.0 A Indication of the radiation beam axis On entry 2 mm A On exit 3 mm A Isocentre Radiation beam axis 2 mm IPEM (1999) 1 mm

AAPM (1994) 2 mm

A, B

Mechanical isocentre 1 mm IPEM (1999) B Indication 2 mm A Distance indication Isocentric equipment 2 mm

IPEM (1999) 3 mm AAPM (1994) 2 mm

A, B

Non-isocentric equipment 5 mm A Zero position of rotational scales Gantry rotation 0.5° IPEM (1999) B Roll and pitch of radiation head 0.1° A Rotation of beam limiting system 0.5° IPEM (1999) B Isocentric rotation of the patient support 0.5° A Table top rotation, pitch and roll 0.5° A Accuracy of rotation scales 1° IPEM (1999) B Congruence of opposed radiation fields

1 mm A

Movements of patient support Vertical movements 2 mm A Longitudinal and lateral movements 2 mm IPEM (1999) B Isocentric rotation axis 1 mm A Parallelism of rotational axes 0.5° A Longitudinal rigidity 5 mm A Lateral rigidity 0.5° and 5 mm A

1

3.10. KILOVOLTAGE UNITS 2

IEC 60601-2-8 (1997a) is the standard which identifies those features of design that are 3




hazards. Tests are based upon IPEM Report 81 (1999), which is based on a survey of UK 7

practice in 1991. Where recommendations from other bodies are adopted, they are 8


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indicated in the table. For a detailed description of test methods and conditions, please refer 1

to the IPEM (1999) and CAPCA (2005d) documents. 2


control, suggested frequencies of testing are given in IPEM (1999) and the CAPCA (2005d) 4

standard. 5

6


values for acceptance testing and quality control of kilovoltage units 8


Level

Reference (IPEM, 1999) unless stated)

Type

Output calibration 3 % B Monitor chamber linearity (if present) 2 % B Timer end error 0.01 min B Timer accuracy 2 % B Coincidence of light and x-ray beams 5 mm CAPCA (2005d) 2

mm B

Field Uniformity 5 % B HVL constancy 10 % B Measurement of HVL 10 % B Applicator output factors 3 % B 9

3.11. BRACHYTHERAPY 10

IEC 60601-2-17 (2004c) is the standard which identifies those features of design that are 11




hazards (i.e. controlling timer, selection and display of treatment related parameters and 15

leakage radiation). This safety standard requires in the technical description the statement 16

of tolerances for radioactive source positioning, transit time and dwell time. It also limits the 17

value for the positioning accuracy to 2 mm relative to the specified position. 18

The values given in Table 4.6 are based on the tolerance values in ESTRO Booklet No. 8 19

(2004b), AAPM Report No. 46 (1996) and the CAPCA (2006b) standard. 20


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All tests form part of acceptance testing. For a detailed description of test methods and 1

conditions, please refer to the documents above. Where tests are performed routinely for 2

quality control, suggested frequencies of testing are given in the documents indicated in the 3

Table. 4


values for acceptance testing and quality control of brachytherapy equipment 6


Level

Reference (ESTRO, 2004B)

Type

Source calibration Single source when only one source used (e.g. HDR)

3 % AAPM (1994) B

Individual source in a batch Mean of batch (e.g. LDR or permanent implant)

5 % 3 %

B

Linear source uniformity of wire sources 5 % B Source position 2 mm B Applicator length 1 mm AAPM (1994) B Controlling timer 1 % AAPM (1994) B Transit time 1 % CAPCA (2006b) B 7

3.12. TREATMENT PLANNING SYSTEMS 8

IEC 62083 (2001b) “Requirements for the safety of radiotherapy treatment planning 9

systems” (RTPS) is the standard which identifies those features of design that are regarded 10

as essential for the safe operation of the equipment. It states that “the output of a RTPS is 11

used by appropriately qualified persons as important information in radiotherapy treatment 12

planning. Inaccuracies in the input data, the limitations of the algorithms, errors in the 13

treatment planning process, or improper use of output data, may represent a safety hazard 14

to patients should the resulting data be used for treatment purposes.” It is principally a 15

software application for medical purposes and is a device that is used to simulate the 16

application of radiation to a patient for a proposed radiotherapy treatment. 17

IAEA-TECDOC-1540 (2007b), addresses specification and acceptance testing of RTPSs, 18

using the IEC 62083 (2001a) document as a basis. This document gives advice on tests to 19

be performed by the manufacturer (type tests) and acceptance tests to be performed at the 20


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hospital (site tests). IAEA-TECDOC-1583 (2008a) addresses the commissioning of RTPSs. 1

Both are restricted to photon beam planning, but IMRT is not included. Criteria for the 2

acceptability of performance tolerances of IMRT plans, e.g. based on gamma calculations, 3

are an area of development and are not considered in this document. The IEC has not 4

published performance tolerances for RTPSs, and the tolerances for RTPS for photon 5

beams in table 4.7 are taken from IAEA-TECDOC-1583 (2008a), where descriptions of test 6

methods and conditions can also be found. 7


values for acceptance testing and quality control of external beam RTPSs 9


Level

Reference (IAEA, 2008a)

Type

Output factors at the reference point 2 % A Homogeneous, simple geometry Central Axis data of square and rectangular fields 2 % A

Off-axis data 3 % A Complex geometry Wedged fields, inhomogeneities, irregular fields, asymmetric collimator setting; Central and off-axis data

3 % A

Outside beam edges In simple geometry 3 % A In complex geometry 4 % A Radiological field width 50% - 50% distance 2 mm A Beam fringe / penumbra (50% - 90%) distance 2 mm A

QA for treatment planning systems is described in IAEA TRS-430 (2004a), AAPM (1998b), 10

ESTRO Booklet No 7 (2007a) for photon beams only and ESTRO Booklet No 8 (2007b) for 11

brachytherapy and the national protocols IPEM (1999) and CAPCA (2007a). 12

3.13. DOSIMETRY EQUIPMENT 13

The quality assurance of dosimetry equipment is considered by AAPM (1994), IPEM (1999) 14

and the CAPCA (2007c) standards. The CAPCA standard is largely based upon AAPM 15

(1994), but with some local measurements. IPEM (1999) has the most quantitative 16

measures. The tests from all reports are set out below in Table 4.8. For a detailed 17

description of test methods and conditions, please refer to these documents. Where tests 18


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are performed routinely for quality control, suggested frequencies of testing are given in 1

these documents. 2


values for acceptance testing and quality control of dosimetry equipment 4

Physical Parameter Tolerance/ Suspension Level

Reference (IPEM, 1999)

Type

Ionisation Chambers Leakage current 0.1 % AAPM (1994) B Linearity 0.5 % AAPM (1994) B Radionuclide stability check ≤ 1 % Calibration against secondary standard 1 % Beam Data Acquisition Systems Positional accuracy 1mm CAPCA (2000c) B Linearity 0.5 % AAPM (1994) B Ion recombination losses 0.5 % B Leakage current 0.1 % AAPM (1994) 0.5 % B Effect of RF fields 0.1 % B Stability of compensated signal 0.2 % B Standard percentage depth dose plot 0.5 % B Constancy of standard percentage depth dose plot

0.5 % B

Standard profile plot: flatness 3 % B Standard profile plot: field size 2 mm B Accessories Thermometer Calibration 0.5 deg C AAPM (1994) 0.1deg C B Barometer calibration 1 mbar B Linear rule calibration 0.3 % AAPM (1994) B 5

3.14. RADIOTHERAPY NETWORKS 6

Modern radiotherapy techniques rely on the transfer of large quantities of data and images 7

and require reliable data networks for safety and consistency. Quality control largely relates 8

to checking the correct functionality of processes and safety software, the accuracy of new 9

hardware and software and the comparison of data sets, sent, received or stored. Testing 10

most often occurs with the introduction of new developments. Regular testing can be 11

valuable to check for data corruption and hardware faults. 12

The guidance in this section is taken from IPEM Report 93 “Guidance for the 13

Commissioning and Quality Assurance of a Networked Radiotherapy Department” (2006) 14


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and the parameters needing to be checked routinely are listed in Table 4.9 below. See 1

IPEM Report 93 (2006) for a full description of the methods for checking these parameters. 2

Reference can also be made to ISO 17799:2005 “Information Technology – Security 3

Techniques – Code of Practice for Information Security Management” (2005) for general 4

advice on information security and national data protection legislation may also be 5

appropriate. 6

No suspension levels are given in table 4.9 because functionality must be correct for the 7

integrity of the data and its transfer. When a loss of functionality is detected, the use of the 8

network should be suspended until correct functionality is restored. 9

Table 4.9 Operating parameters to be checked routinely 10

Operating Parameter Review of changes in assets, patch history, data stored, data disclosures, uses of data, new or changed equipment and application software Check of security fixes for Operating Systems and applications Check that anti-virus software is up to date and enabled appropriately Monitor logs for unexpected activity Monitor availability of security updates and service packs on manufacturer’ websites Establish and monitor physical and network boundaries. Look for changes. Check physical controls are in place and are effective Communication channels Dial out: Check that dial-in is not possible after changes in system configuration or system upgrades. Check telephone numbers are dialled correctly. Check that assigned telephone numbers have not been altered. Check log records for all attempted connections, times, dates and endpoints Auto answer (dial-in): Check lists of allowed dial-in sources, allowed times and any changes in configuration settings, dial-back settings, etc. Check logs are as expected All: Monitor link error rates. Check the accuracy of data transmission. Check traffic encryption operating. Check for duplicate IP addresses. Monitor traffic for the presence of new “unexpected” protocols, promiscuous mode on interfaces or unknown devices appearing on the network Check physical integrity of cables and terminations. Monitor and document changes in physical network configuration. Monitor SNMP traffic logs for significant changes DCHP: Monitor changes in the configuration files. Test DNS/DHCP allocation is proceeding correctly. Look for new hosts in the lease allocation logs and new additions to the network Check routing tables are correct for static routes and that routed and gated daemons are functional for dynamic routes. Check for propagation of routing information outside network boundaries Check that firewall rules have not been altered. Check that only allowed hosts, services or packets are going through as new devices and applications are added to interior and exterior networks. Check firewall log for intrusion signatures


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Establish which common services are necessary and provide a means of monitoring and controlling access to them. Check that all essential services are operational Perform security audits of physical location of clients, servers and other critical hardware. Review access control measures and administrative personnel lists. Monitor logs for console access and machine reboots, looking for discrepancies Check logs for remote access and firewall logs for inappropriate clients or protocols Examine system logs looking for sessions that are outside expected norms Review and update the list of OSs, versions, service packs, applications and patch levels. Test applied patches and updates as required in accordance with manufacturer’s instructions Perform checks for new MAC addresses on the network (DHCP does this automatically). Check that unused ports are disabled and/or unpatched. Check that used ports are set to fixed MAC addresses where possible Check the operation and configuration of the authentication system. Check the signatures for the configuration files. Check password change dates are operating as planned. Check that back door or manufacturer’s passwords are not enabled or are changed regularly Monitor accounts added to the system for excessive permissions. Monitor system logs for invalid administration log-in attempts Transfer test data and checksum. Check for the addition of new fields and data types on host systems. For DICOM transfers, use the DICOM ECHO verification service to check connectivity and handshaking. For HL7 transfers, check connectivity Check backup logs for errors and omissions, and error rates to verify the media is good and hardware is not failing. Backup policy must include a retirement age for media. Destroy data no longer required. Practice disaster recovery regularly Review data flows looking for new cached items. Run reports checking the coherency of the data across the system Check for the effect of software upgrades, new equipment added, changes in configuration and data files. Check the signatures of significant files and update if necessary. Verify that the change control process is working Perform checks that permissions and shares have not changed from those expected Monitor available space, CPU utilisation and use of swap memory on critical devices Check NTP client logs for synchronisation failures. Check reference time sources for offset and stability. Check that server and client time zone settings have not been modified. Check system time against an independent time source Check that record locking on files and databases have not been broken after any OS changes including service packs, client set-up changes and upgrades Data Unique identification Geometric integrity and scaling Region of acceptability of data accuracy and integrity Coordinate frame orientation and location Patient orientation and specification within the coordinate frame Tolerances on images with respect to

• pixel values • geometric distortion

1


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APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE 1

The general purpose of medical imaging is to obtain adequate image quality at the lowest possible 2

radiation burden to the patient. Assessment of image quality is, therefore, important. Various 3

methods are available for quantification of image quality (Table DR1.1 based on ICRU Report 54, 4

1995). 5

Table A1.1 Assessment of (image) quality at various physical/medical levels 6

Approach Methods used Physical (fundamental) image quality

Large-scale transfer function (characteristic curve), spatial resolution (transfer function), noise (noise power spectra)

Statistical decision theory Ideal observer formalism, other observers Psychophysical approach (ROC) analysis, contrast detail method Quality assessment using phantoms for a specific imaging task

Specific test objects, e.g. for high and low contrast spatial resolution

Examination of images of patients European image quality criteria (diagnostic radiographic and CT images)

7

The methods range from those requiring high levels of expertise and facilities (transfer functions), 8

are very elaborate (ROC analysis) to methods which are in principle applicable in the field in a 9

department of radiology. 10


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APPENDIX 2 AUTOMATIC EXPOSURE CONTROL 1

Methodology, CR and DDR 2

CR, DDR and AEC 3

The following Tables provide additional information in connection with CR and DDR AEC. 4

They are complementary to the data in Section 2.2 of the text. 5

Table A2.1 Acceptability criteria for the AEC device (CR) 6

Physical parameter Suspension Level Reference Criterion Notes Consistency between

chambers Mean ± 20% IPEM

(2005a) B Attenuation

material Repeatability Mean ± 30% IPEM


material Consistency Mean ± 60% IPEM


material

Image receptor dose

Speed Class 400: > 2.5 µGy± 60%

Speed Class 200:

> 5 µGy± 60%

IPEM (2005a)

B Dosemeter. 1mm-2mm copper filter

Table A2.2 Acceptability criteria for AEC device (DDR) 7

Physical parameter Suspension Level

Reference Criterion Method

Consistency between chambers

IPEM (2005a) B Attenuation material

Repeatability Mean ± 30% IPEM (2005a) B Attenuation material

Consistency Mean ± 60% IPEM (2005a) B Attenuation material

Image receptor dose

Manufacturers Specification ±

60%

IPEM (2005a) B Dosemeter, 1.0mm copper.


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APPENDIX 3 EQUIPMENT 1

Quality Control Equipment for Radiology 2 3 Calibration 4

Instruments should have calibration traceability. Dosimetric instrumentation should comply 5

with IEC (1997b) and follow international guidelines (IAEA, 2004b). Care should be taken 6

for measurements in the beam conditions outside of those defined by IEC (1997b) (e.g. 7

some situations in mammography, computed tomography and interventional radiology and 8

all situations involving scatter radiation). In these conditions the use of instruments with a 9

small energy response variation is strongly encouraged. Field (or clinical) KAP meter 10

calibration should be performed in situ using a calibrated reference instruments using one 11

of two methods as described in IAEA (2007a) and Toroi, Komppa and Kosunen (2008). 12

Some useful equipment 13

Radiographic instrumentation 14

• Calibrated non invasive tube kVp meter (IAEA, 2007a) 15 • Dosimeter calibrated in terms of air kerma free-in-air with specialized detectors for 16

measurements in different modalities (ICRU, 2005; IAEA, 2007a). 17 • Indication of current exposure time product (on the x-ray unit or by ancillary 18

equipment). 19 • Instrument calibrated for measurement of exposure time. 20

Auxiliary equipment 21 • Accurate tape measure and steel rule 22 • Aluminium filters (type 1100, purity > 99%) ranging from 0.25 mm to 2 mm (HDWA, 23

2000). 24 • Lead rubber sheet(s). 25 • Attenuator set and supports 26 • Radio-opaque grid or equivalent 27 • Collimation and Alignment tools: X-ray field mapping device, e.g. radiographic film, 28

Gafchromic film or equivalent. 29 • Radio-opaque markers – coins or paper clips. 30 • Small lead or copper block 31 • Film Screen Contact Test Tool (Mesh Test Tool). 32 • Non-mercury thermometer, with a range of 25-40 oC and an accuracy of ± 0.1oC. 33 • Geometry test object 34 • High contrast resolution tool (Hüttner 18) 35


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Phantoms 1 • Standard CT dose phantoms, Body 32-cm PMMA, Head 16 cm PMMA 2 • CT uniformity (water) phantoms 3 • Slice thickness phantom; Inclined planes – axial acquisition, Thin disc or bead 4 • Measurements to assess the performance of DXA units may have to be performed 5

using test equipment, some of which is specifically designed for that purpose 6 • PMMA phantoms of 10, 12, 15, 18 and 20 cm thickness. 7 • Standard phantom, e.g.: European Spine Phantom [7, 12], BFP [8] 8

Tomography 9 • Test tool (BIR, 2001; IPEM, 1997b). 10 • Test tool for angle of swing, i.e. a 45º foam pad, pin-hole or other appropriate test 11

tool (IPEM, 1997b) 12

Instrumentation for light and image display 13 • Calibrated Photometer for measuring luminance and illuminance. 14 • Test pattern Image such as SMPTE or T018-QC 15 • Calibrated Sensitometer with 21 steps or pre-exposed sensitometry strips. 16 • Calibrated Densitometer, accuracy of ± 0.01 OD. 17

18

19


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REFERENCES & SELECTED BIBLIOGRAPHY 1

2

AAPM (1992) American Association of Physicists in Medicine. Recommendations on performance 3 characteristics of diagnostic exposure meters. AAPM Report No 35. (Also published in Med. Phys. 4 19 (1) 231-241. [Medline] 5

AAPM (1994) American Association of Physicists in Medicine. Comprehensive QA for Radiation 6 Oncology. Report No 46. Med. Phys. 21 (4), 581-618. 7

AAPM (1995) American Association of Physicists in Medicine. Quantitation of SPECT Performance. 8 Report No 52. Med. Phys. 22 (4) April. 9

AAPM (1997) American Association of Physicists in Medicine. Code of practice for brachytherapy 10 physics. Report No 59. Med. Phys. 24 (10), 1557-1598. 11

AAPM (1998a) American Association of Physicists in Medicine. High dose-rate brachytherapy 12 treatment delivery. Report No 61. Med. Phys. 25 (4), 375-403. 13

AAPM (1998b) American Association of Physicists in Medicine. Quality assurance for clinical 14 radiotherapy treatment planning. Report No 62. Med. Phys. 25 (10), 1773-1829. 15

AAPM (2002) American Association of Physicists in Medicine. Quality control in diagnostic 16 radiology. Report No 74. July. New York: American Institute of Physics. 17

AAPM (2003) American Association of Physicists in Medicine. Quality assurance of computed-18 tomography simulators and the computed-tomography-simulation process. Report No 83. Med. 19 Phys. 30 (10), 2762-2792. 20

AAPM (2005) American Association of Physicists in Medicine. Assessment of display performance 21 for medical imaging systems. Report OR-03. [Online] Available at 22 http://www.aapm.org/pubs/reports/OR_03.pdf (Accessed: 30 September 2009) 23

AAPM (2006a) American Association of Physicists in Medicine. Acceptance testing and quality 24 control of Photo Stimulable Phosphor Imaging Systems. Report No 93. New York: American 25 Institute of Physics. 26

AAPM (2006b) American Association of Physicists in Medicine. Validating Film Processor 27 Performance. Report No 94. November. College Park, MD: American Association of Physicists in 28 Medicine. 29

Adrian Committee (1960). Radiological Hazards to Patients. Second Report to the Committee. 30 London: Her Majesty’s Stationery Office. 31

AFSSAPS (2007) Agence Française de Sécurité Sanitaire des Produits de Santé. ‘Protocole 32 AFSSAPS CT’, Journal Officiel de la République Française. 33

ARPANSA (2005) Australian Radiation Protection and Nuclear Safety Agency. Code of Practice & 34 Safety Guide. Radiation Protection Series No. 10, December. Australia: Radiation Protection in 35 dentistry. 36

Besluit van het FANC (2008, December 12) Belgian directive: Aanvaardbaarheidscriteria voor 37 röntgenapparatuur voor diagnostisch gebruik in de tandheelkunde. 38


of 103

BIR (2001) British Institute of Radiology. Assurance of Quality in the Diagnostic X-ray Department. 1 2nd edn. London: British Institute of Radiology. 2

BSI (1994) British Standards Institute. BS EN ISO 9002: Quality Systems – Specification for 3 Production, Installation and Servicing. London: British Standards Institute. 4

Bland, W. F. (1994) ‘CEC suggested technical criteria for radiodiagnostic equipment’. September. 5

CAPCA (2005a) Canadian Association of Provincial Cancer Agencies. Standards for Quality 6 Control at Canadian Radiation Treatment Centres, Medical Linear Accelerators. Canada. 7

CAPCA (2005b) Canadian Association of Provincial Cancer Agencies. Standards for Quality 8 Control at Canadian Radiation Treatment Centres, Conventional Radiotherapy Simulators. Canada. 9

CAPCA (2005c) Canadian Association of Provincial Cancer Agencies. Standards for Quality 10 Control at Canadian Radiation Treatment Centres, Electronic Portal Imaging Devices. Canada. 11

CAPCA (2005d) Canadian Association of Provincial Cancer Agencies. Standards for Quality 12 Control at Canadian Radiation Treatment Centres, Kilovoltage X-ray Radiotherapy Machines. 13 Canada. 14

CAPCA (2006a) Canadian Association of Provincial Cancer Agencies. Standards for Quality 15 Control at Canadian Radiation Treatment Centres, Cobalt-60 Teletherapy Units. Canada. 16

CAPCA (2006b) Canadian Association of Provincial Cancer Agencies. Standards for Quality 17 Control at Canadian Radiation Treatment Centres, Brachytherapy Remote Afterloaders. Canada. 18

CAPCA (2007a) Canadian Association of Provincial Cancer Agencies. Standards for Quality 19 Control at Canadian Radiation Treatment Centres, Treatment Planning Systems. Canada. 20

CAPCA (2007b) Canadian Association of Provincial Cancer Agencies. Standards for Quality 21 Control at Canadian Radiation Treatment Centres, CT-Simulators. Canada. 22

CAPCA (2007c) Canadian Association of Provincial Cancer Agencies. Standards for Quality 23 Control at Canadian Radiation Treatment Centres, Major Dosimetry Equipment. Canada. 24

CEC (2006) Commission of the European Communities. European guidelines for quality assurance 25 in mammography screening. 4th Edn. Luxembourg: European Commission. 26

Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic 27 safety standards for the health protection of the general public and workers against the dangers of 28 ionizing radiation. OJ L 246, 17.9.1980, p. 1–72. 29

Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the 30 radiation protection of persons undergoing medical examination or treatment. OJ L 265, 5.10.1984, 31 p. 1–3 32

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169, 12.7.1993, p. 33 1 34

Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the 35 protection of the health of workers and the general public against the dangers arising from ionizing 36 radiation. OJ L 159, 29.6.1996, p. 1–114 37


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Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the 1 dangers of ionizing radiation in relation to medical exposure, and repealing Directive 2 84/466/Euratom. OJ L 180, 9.7.1997, p. 22–27 3

CRCPD (2002) Conference of Radiation Control Program Directors, Inc. CRCPD Publication E-02-4 4: Nationwide evaluation of x-ray trends (NEXT) Tabulation and Graphical Summary of 1996 5 Fluoroscopy Survey. October. Kentucky: Conference of Radiation Control Program Directors, Inc. 6

Dietzel, G. (2003) ‘Quality Control of PET labelled Agents by TLC, GC and HPLC’. Journal of 7 Radioanalytical and Nuclear Chemistry, 257, (1), pp. 187-189. 8

DIN V 6868-58 (2001-01) Image quality assurance in diagnostic X-ray departments - Part 58: 9 Acceptance testing of projection radiography systems with digital image receptors. Berlin: Deutches 10 Institut fur Normung. 11

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 12 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States 13 relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical 14 devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with 15 EEA relevance). OJ L 247, 21.9.2007, p. 21–55 16

Directive R-08-05. Contrôle de qualité des installations de radiographie dentaire numérique.May 19, 17 2005. Bundesamt für Gesundheit. Switzerland: Office Fédéral de la santé publique. 18

Dowling, A., Gallagher, A., O’Connor, U., Larkin, A., Gorman, D., Gray, L. and Malone, J.F. (2008) 19 ‘Acceptance testing of fluoroscopy systems’. Radiat Prot Dosimetry: 129 (1-3) p. 291-294. 20

ESTRO Booklet No. 7 (2004a) European Society for Therapeutic Radiology and Oncology. Quality 21 Assurance of Treatment Planning Systems Practical Examples for Non-IMRT Photon Beams. 22 Brussels: ESTRO. 23

ESTRO Booklet No. 8 (2004b) European Society for Therapeutic Radiology and Oncology. 24 European Guidelines for Quality Assurance in Radiotherapy. A Practical Guide to Quality Control of 25 Brachytherapy Equipment. Brussels: ESTRO. 26

European Commission (1996a) Report EUR 16635 EN: The 1991 CEC Trial on Quality Criteria for 27 Diagnostic Radiographic Images: Detailed Results and Findings. Luxembourg: Office for Official 28 Publications of the European Communities. 29

European Commission (1996b) EUR 16260 EN: European Guidelines on Quality Criteria for 30 Diagnostic Radiographic Images. Luxembourg: Office for Official Publications of the European 31 Communities. 32

European Commission (1996c) EUR 16261: European Guidelines on Quality Criteria for Diagnostic 33 Radiographic Images in Paediatrics. Luxembourg: Office for Official Publications of the European 34 Communities. 35

European Commission (1997) Radiation Protection 91: Criteria of acceptability of Radiological 36 (including Radiotherapy) and Nuclear Medicine installations. Luxembourg: Office for Official 37 Publications of the European Communities. 38

European Commission (2004) Radiation Protection 136: European Guidelines on Radiation 39 Protection In Dental Radiology, The Safe Use Of Radiographs In Dental Practice. Luxembourg: 40 Office for Official Publications of the European Communities. 41


of 103

Gallagher, A., Dowling, A., Devine, M., Bosmans, H., Kaplanis, P., Zdesar, U., Vassileva, J., & 1 Malone, J. F. (2008). ‘European Survey of Dental X-Ray Equipment’. Radiat Prot Dosimetry: 129 p. 2 284-287. 3

Genant, H.K., Grampp, S., Glüer, C.C., Faulkner, K.G., Jergas, M., Engelke, K., and Hagiwara, S., 4 Van Kuijk, C. (1994) ‘Universal standardization for dual x-ray absorptiometry: patient and phantom 5 cross-calibration results’. J Bone Miner Res: 9 (10) p. 1503-14 6

Greenfield, J.R., Samaras, K., Chisholm, D.J., and Campbell, L.V. (2002) ‘Regional intra-subject 7 variability in abdominal adiposity limits usefulness of computed tomography’. Obes Res: 10 (4) p. 8 260-5. 9

Guidance Notes for Dental Practitioners on the Safe Use of X-ray Equipment. (2001). UK: National 10 Radiological Protection Board and Department of Health. 11

Halkar, R. K., and Aarsvold, J. N. (1999) ‘Intraoperative Probes’. Journal of Nuclear Medicine 12 Technology: 27 (3) September p. 188-192. 13

Halpern, E.J. (1995) ‘A test pattern for quality control of laser scanner and CCD film digitizers’. J.D. 14 Imaging: 8: 3-9. 15

HDWA (2000) Health Department of Western Australia. Radiation safety act 1976, diagnostic x-ray 16 compliance testing. Australia: Program Requirements. 17

IAEA (1994) International Atomic Energy Agency. IAEA Technical Report Series 374: Calibration of 18 Dosimeters used in Radiotherapy. Vienna: International Atomic Energy Agency. 19

IAEA (1996) International Atomic Energy Agency. IAEA Safety Series 115: International Basic 20 Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. 21 Vienna: International Atomic Energy Agency. 22

IAEA (2000) International Atomic Energy Agency. IAEA Safety Reports Series No. 16: Calibration of 23 Radiation Protection Monitoring Instruments. Vienna: International Atomic Energy Agency. 24

IAEA (2004a) International Atomic Energy Agency. IAEA Report TRS-430: Commissioning and 25 Quality Assurance of Computerized Planning Systems for Radiation Treatment of Cancer. Vienna: 26 International Atomic Energy Agency. 27

IAEA (2004b) International Atomic Energy Agency. IAEA Technical Reports Series No. 457: 28 Dosimetry in Diagnostic Radiology: An International Code of Practice. Vienna: International Atomic 29 Energy Agency. 30

IAEA (2006) International Atomic Energy Agency. IAEA Technical Report Series No. 454: Quality 31 Assurance of Radioactivity Measurements in Nuclear Medicine. STI/DOC/010/454. Vienna: 32 International Atomic Energy Agency. 33

IAEA (2007a) International Atomic Energy Agency. IAEA Technical Report Series No. 457: 34 Dosimetry in Diagnostic Radiology: An International Code of Practice. STI/DOC/010/457. Vienna: 35 International Atomic Energy Agency. 36

IAEA (2007b) International Atomic Energy Agency. IAEA-TECDOC-1540: Specification and 37 Acceptance testing of Radiotherapy Treatment Planning Systems. Vienna: International Atomic 38 Energy Agency. 39

IAEA (2007c) International Atomic Energy Agency. IAEA-TECDOC: Quality Control of SPECT 40 Systems.2007 edn. Vienna: International Atomic Energy Agency. 41

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Genant%20HK%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Grampp%20S%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Gl%C3%BCer%20CC%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Faulkner%20KG%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Jergas%20M%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Engelke%20K%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Hagiwara%20S%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Van%20Kuijk%20C%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus


of 103

IAEA (2008a) International Atomic Energy Agency. IAEA-TECDOC-1583: Commissioning of 1 Radiotherapy Treatment Planning Systems: Testing for Typical External Beam Treatment 2 Techniques. Vienna: International Atomic Energy Agency. 3

IAEA (2008b) International Atomic Energy Agency. Guidelines for the use of DXA in measuring 4 bone density and soft tissue body composition: A Handbook Rep. TBA. Vienna: International Atomic 5 Energy Agency. 6

IAEA (2009) International Atomic Energy Agency. Human Health Series No. 1: Quality Assurance 7 for PET and PET/CT Systems. Vienna: International Atomic Energy Agency. 8

ICRP (1991) International Commission on Radiological Protection. Publication 60: 1990 9 Recommendations of the International Commission on Radiological Protection. Annals of the ICRP 10 21 (1-3). Oxford: Pergamon Press. 11

ICRP (1996) International Commission on Radiological Protection. Publication 73: Radiological 12 Protection and Safety in Medicine. Annals of the ICRP 26 (2). Oxford: Pergamon Press. 13

ICRU (1992) International Commission on Radiation Units and Measurements. Measurement of 14 Dose Equivalents from External Photon and Electron Radiations (Report 47). Bethesda: 15 International Commission on Radiation Units and Measurements. 16

ICRU (1995) International Commission on Radiation Units and Measurements. Medical Imaging - 17 The Assessment of Image Quality (Report 54). Bethesda: International Commission on Radiation 18 Units and Measurements. 19

ICRU (2005) International Commission on Radiation Units and Measurements. Patient Dosimetry 20 for X-Rays Used in Medical Imaging (Report 74). Journal of the ICRU: 5 (2). Bethesda: International 21 Commission on Radiation Units and Measurements. 22

IEC (1993a) International Electrotechnical Commission. IEC 61168 Ed.1.0: Radiotherapy simulators 23 – Functional performance characteristics. Geneva: IEC. 24

IEC (1993b) International Electrotechnical Commission. IEC 61170 Ed 1.0: Radiotherapy simulators 25 – Guidelines for functional performance characteristics. Geneva: IEC. 26

IEC (1993c) International Electrotechnical Commission. IEC/TS 61223-2-1 Ed 1.0: Evaluation and 27 routing testing in medical imaging departments - Part 2-1: Constancy tests - Film processors. 28 Geneva: IEC. 29

IEC (1993d) International Electrotechnical Commission. IEC/TS 61223-2-2: Evaluation and routing 30 testing in medical imaging departments - Part 2-2: Constancy tests - Radiographic Cassettes and 31 Film changers, Film Screen Contact and relative sensitivity of the screen cassette assembly. 32 Geneva: IEC. 33

IEC (1993e) International Electrotechnical Commission. IEC/TS 61223-2-3: Evaluation and routing 34 testing in medical imaging departments - Part 2-3: Constancy tests - Darkroom Safelight Conditions. 35 Geneva: IEC. 36

IEC (1993f) International Electrotechnical Commission. IEC/TS 61223-2-12: Evaluation and routing 37 testing in medical imaging departments - Part 2-3: Constancy tests - Film Illuminators. Geneva: IEC. 38

IEC (1994a) International Electrotechnical Commission. IEC 61223-2-4 Ed 1.0: Evaluation and 39 routine testing in medical imaging departments - Part 2-4: Constancy Tests - Hard copy cameras. 40 Geneva: IEC. 41


of 103

IEC (1994b) International Electrotechnical Commission. IEC 61223-2-5 Ed 1.0: Evaluation and 1 routine testing in medical imaging departments - Part 2-5: Constancy Tests - Image display devices. 2 Geneva: IEC. 3

IEC (1994c) International Electrotechnical Commission. IEC 61303 Ed 1.0: Medical electrical 4 equipment – Radionuclide calibrators – Particular methods for describing performance. Geneva: 5 IEC.] 6

IEC (1997a) International Electrotechnical Commission. IEC 60601-2-8 Ed 1.0: Medical electrical 7 equipment – Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment 8 operating in the range 10kV to 1MV. Geneva: IEC. 9

IEC (1997b) International Electrotechnical Commission. IEC-61674 Ed 1.0: Medical Electrical 10 Equipment - Dosimeters with Ionization Chambers and/or Semi-conductor Detectors as used in X-11 Ray Diagnostic Imaging. Geneva: IEC. 12

IEC (1998a) International Electrotechnical Commission. IEC 60601-2-1 Ed 2.0: Medical electrical 13 equipment – Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 14 MeV to 50 MeV. Geneva: IEC. 15

IEC (1998b) International Electrotechnical Commission. IEC 61675-2 Ed 1.0: Radionuclide Imaging 16 Devices – Characteristics and Test Conditions – Part 2: Single Photon emission computed 17 tomographs. Geneva: IEC. 18

IEC (1998c) International Electrotechnical Commission. IEC 61675-3 Ed 1.0: Radionuclide Imaging 19 Devices – Characteristics and test Conditions – Part 3: Gamma Camera based whole body imaging 20 systems. Geneva: IEC. 21

IEC (1999) International Electrotechnical Commission. IEC 60522 Ed 2.0: Determination of the 22 permanent filtration of X-ray tube assemblies. Geneva: IEC. 23

IEC (2000a) International Electrotechnical Commission. IEC 61223-3-4 Ed 2.0: Evaluation and 24 routine testing in medical imaging departments – Part 3.4: Acceptance tests – Imaging performance 25 of dental X-ray equipment. Geneva: IEC. 26

IEC (2000b) International Electrotechnical Commission. IEC 60601-2-43 Ed 1.0: Medical Electrical 27 Equipment. Part 2-43: Particular Requirements for Safety of x-Ray Equipment for interventional 28 Procedures. Geneva: IEC. 29

IEC (2001a) International Electrotechnical Commission. IEC TR 61948-1 Ed 1.0: Nuclear medicine 30 instrumentation – Routine tests – Part 1: Radiation counting systems. Geneva: IEC. 31

IEC (2001b) International Electrotechnical Commission. IEC 62083: Medical electrical equipment – 32 Requirements for the safety of radiotherapy treatment planning systems. Geneva: IEC. 33

IEC (2003a) International Electrotechnical Commission. IEC 60336: Medical electrical equipment – 34 x-ray tube assemblies for medical diagnosis: Characteristics of focal spot sizes. Geneva: IEC. 35

IEC (2003b) International Electrotechnical Commission. IEC 60601-1: Medical electrical equipment 36 – Part 1: General requirements for basic safety and essential performance. Geneva: IEC. 37

IEC (2004a) International Electrotechnical Commission. IEC 61223-3-5 Ed 1.0: Evaluation and 38 Routine Testing in Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging 39 Performance of Computed Tomography X-ray Equipment. Geneva: IEC. 40


of 103

IEC (2004b) International Electrotechnical Commission. IEC 60601-2-11-am1 Ed 2.0: Amendment 1 1 - Medical electrical equipment – Part 2-11: Particular requirements for the safety of gamma beam 2 therapy equipment. Geneva: IEC. 3

IEC (2004c) International Electrotechnical Commission. IEC 60601-2-17 Ed 2.0: Medical electrical 4 equipment – Part 2-17: Particular requirements for the safety of automatically-controlled 5 brachytherapy afterloading equipment. Geneva: IEC. 6

IEC (2004d) International Electrotechnical Commission. IEC 61675-2-am1 Ed 1.0: Radionuclide 7 Imaging Devices – Characteristics and Test Conditions – Part 2: Single Photon emission computed 8 tomographs. Geneva: IEC. 9

IEC (2005a) International Electrotechnical Commission. IEC 60789 Ed 3.0: Medical Electrical 10 Equipment – Characteristics and Test Conditions of Radionuclide Imaging Devices – Anger Type 11 Gamma Cameras. Geneva: IEC. 12

IEC (2005b) International Electrotechnical Commission. IEC TR 61948-3 Ed 1.0: Nuclear medicine 13 instrumentation – Routine tests – Part 3: Positron emission tomographs. Geneva: IEC. 14

IEC (2006) International Electrotechnical Commission. IEC TR 61948-4 Ed 1.0: Nuclear medicine 15 instrumentation – Routine tests – Part 4: Radionuclide calibrators. Geneva: IEC. 16

IEC (2007) International Electrotechnical Commission. IEC 60976 Ed 2.0: Medical electrical 17 equipment – Medical electron accelerators - Functional performance characteristics. Geneva: IEC. 18

IEC (2008a) International Electrotechnical Commission. IEC 60601-1-3: Medical electrical 19 equipment – Part 1-3: General requirements for basic safety and essential performance – collateral 20 standard. Radiation protection in diagnostic x-ray equipment. Geneva: IEC. 21

IEC (2008b) International Electrotechnical Commission. IEC 60601-2-29 Ed 3.0: Medical electrical 22 equipment – Part 2-29: Particular requirements for the basic safety and essential performance of 23 radiotherapy simulators. Geneva: IEC. 24

IEC (200c) International Electrotechnical Commission. IEC 60977 Ed 2.0: Medical electrical 25 equipment – Medical electron accelerators - Guidelines for functional performance characteristics. 26 Geneva: IEC. 27

IEC (2008d) International Electrotechnical Commission. IEC 61675-1 Ed 1.1: Radionuclide Imaging 28 Devices – Characteristics and test conditions – Part 1: Positron emission Tomography. Geneva: 29 IEC. 30

IEC (2009) International Electrotechnical Commission. IEC 60846-1: Radiation Protection 31 Instrumentation – Ambient and/or directional dose equivalent (rate) meters and/or monitors for beta, 32 X and gamma radiation – Part 1: Portable work place and environmental meters and monitors. 33 Geneva: IEC. 34

IEMA (2004) Institute of Environmental Management and Assessment. BS EN 60846:2004: 35 Radiation protection Instrumentation – Ambient and/or directional dose equivalent (rate) meters 36 and/or monitors for beta, X and gamma radiation. Lincoln: IEMA. 37

IMPACT (2000) Comparison of the imaging performance of CT scanners. Issue 12 (MDA/00/11). 38 London: Department of Health. 39

IPEM (1997a) Institute of Physicists and Engineers in Medicine. Measurement of the Performance 40 Characteristics of Diagnostic X-ray Systems used in Medicine, Report 32, 2nd edn, Part IV: X-ray 41


of 103

Intensifying Screens, Films, Processors and Automatic Exposure Control Systems. York: Institute of 1 Physicists and Engineers in Medicine. 2

IPEM (1997b) Institute of Physics and Engineering in Medicine. Measurement of the performance 3 characteristics of Diagnostic X-Ray Systems used in Medicine, Report 32, 2nd edn, Part V: 4 Conventional Tomography Equipment. York: Institute of Physics and Engineering in Medicine. 5

IPEM (1997c) Institute of Physics and Engineering in Medicine. Recommended Standards for the 6 Routine Performance Testing of Diagnostic X-ray Imaging Systems, Report 77. York: Institute of 7 Physicists and Engineers in Medicine. 8

IPEM (1999) Institute of Physics and Engineering in Medicine. Physical Aspects of Quality Control in 9 Radiotherapy, Report 81. York: Institute of Physics and Engineering in Medicine. 10

IPEM (2002) Institute of Physicists and Engineers in Medicine. Medical and Dental Guidance Notes, 11 A good practice guide on all aspects of ionising radiation protection in the clinical environment. York: 12 Institute of Physicists and Engineers in Medicine. 13

IPEM (2003a) Institute of Physicists and Engineers in Medicine. Measurement of the Performance 14 Characteristics of Diagnostic X-ray Systems used in Medicine, Report 32, 2nd edn, Part III: 15 Computed Tomography X-ray Scanners. York: Institute of Physicists and Engineers in Medicine. 16

IPEM (2003b) Institute of Physics and Engineering in Medicine Quality Assurance in Gamma 17 Camera Systems, Report 86. York: Institute of Physicists and Engineers in Medicine. 18

IPEM (2005a) Institute of Physicists and Engineers in Medicine. Recommended Standards for the 19 Routine Performance Testing of Diagnostic X-Ray Imaging Systems, Report 91. York: Institute of 20 Physicists and Engineers in Medicine. 21

IPEM (2005b) Institute of Physicists and Engineers in Medicine. Commissioning and Routing 22 Testing Of Mammographic X-Ray Systems, Report 89. York: Institute of Physicists and Engineers in 23 Medicine. 24

IPEM (2006) Institute of Physics and Engineering in Medicine. Guidance for the Commissioning and 25 Quality Assurance of a Networked Radiotherapy Department, Report 93. York: Institute of Physics 26 and Engineering in Medicine. 27

IPEM (2008) Institute of Physicists and Engineers in Medicine. Quality Assurance in Dental 28 Radiology, Report 67. York: Institute of Physics and Engineering in Medicine. 29

IPSM, NRPB and CoR (1992) Institute of Physical Sciences in Medicine, National Radiological 30 Protection Board and Royal College of Radiographers. National Protocol for Patient Dose 31 Measurements in Diagnostic Radiology. Chilton: National Radiological Protection Board. 32

IPSM (1994) Institute of Physical Sciences in Medicine. Recommendations for the Presentation of 33 Type test Data for Radiation Protection Instruments in Hospitals, Report 69. IPSM. 34

ISO/IEC (2005) International Organisation for Standardization and International Electrotechnical 35 Commission. ISO/IEC 17799:2005, Information technology – Security techniques – Code of practice 36 for information security management. Geneva: ISO. 37

ISO, IEC, OIML and BIPM (1992) International Organization for Standardization, International 38 Electrotechnical Commission, International Organization of Legal Metrology and International 39 Bureau of Weights and Measures. Guide to the Expression of Uncertainty in Measurement. 1st edn. 40 Geneva: ISO. 41


of 103

Jones, D.G. and Wall, B.F. (1985) Organ Doses from Medical X-Ray Examinations Calculated 1 Using Monte Carlo Techniques. NRPB-R186. London: Her Majesty’s Stationery Office. 2

JORF (2007) Journal Officiel de la République Française. Texte 33 sur 123. October 25. 3

JORF 0300 (26 December), (79) p. 20066. 4

Kal, H. B. and Zoetelief, J. (1995) Criteria for acceptability of radiobiological and nuclear medicine 5 installations: inventory of responses on national criteria. TNO report RD-I/9602-366. 6

Kalender, W.A. (2000) Computed Tomography: Fundamentals, System Technology, Image Quality, 7 Applications. Munich: Publicis MCD Verlag. 8

Kalender, W. A., Felsenberg, D., Genant, H. K., Fischer, M., Dequeker, J. and Reeve, J. (1995) ‘The 9 European Spine Phantom--a tool for standardization and quality control in spinal bone mineral 10 measurements by DXA and QCT’. Eur J Radiol: 20 (2) p. 83-92. 11

Kelly, T.L., Slovik, D.M., and Neer, R.M., (1989) ‘Calibration and standardization of bone mineral 12 densitometers’. J Bone Miner Res: 4 (5) p. 663-9. 13

KCARE (2005a) King’s Centre for the Assessment of Radiological Equipment. Protocol for the QA 14 of Computed Radiography Systems, Commissioning and Annual QA Tests. London: KCare. 15

KCARE (2005b) King’s Centre for the Assessment of Radiological Equipment. Protocol for the QA 16 of Direct Digital Radiography Systems Commissioning and Annual QA Tests. London: KCare. 17

Larkin, A., Sheahan, N., O'Connor, U., Gray, L., Dowling, A., Vano, E., Torbica, P., Salat, D., 18 Schreiner, A., Neofotistou, V., and Malone, J.F. (2008) ‘QA/Acceptance Testing of DEXA X-Ray 19 Systems Used in Bone Mineral Densitometry’. Radiat Prot Dosimetry: 129 (1-3) p. 279 – 283. 20

Lim, A.J. (1996) Image quality in films digitizers: testing and quality assurance. RSNA Categorical 21 Course in Physics, p. 183-193. 22

Luxembourg Annexe 7 (2008) 10.01.08 23

Martin, C.J., Sutton, D.G., Workman, A., Shaw, A.J. and Temperton, D. (1998) ‘Protocol for 24 measurement of surface dose rates for fluoroscopic x-ray equipment’. Brit J Radiol: 71 (852) p. 25 1283-1287. 26

Meeder, R. J. J., Jaffray, D. A., and Munro, P. (1995) ‘Test for evaluating laser film digitizer’. 27 Medical Physics 22 (5) May p. 635-642. 28

Mutic, S., Palta, J. R., Butker, E.K., Das Indra, J., Huq, S.M., Loo Leh-Nien, D., Salter B.J., 29 McCollough C.H., and Van Dyk J. (2003) ‘Quality assurance for computed-tomography simulators 30 and the computed-tomography-simulation process: report of the AAPM Radiation Therapy 31 Committee, Report 83’. Medical Physics 30 (10) p. 2762-92. 32

Nagel, H.D. (ed.) (2002) Radiation Exposure in Computed Tomography: Fundamentals, Influencing 33 Parameters, Dose Assessment, Optimisation, Scanner Data, Terminology. 4th edn. Hamburg: CTB 34 Publications. 35

Nakao, R., Furutuka, K., Yamaguchi, M. and Suzuki, K. (2006) ‘Quality Control of PET 36 Radiopharmaceuticals using HPLC with Electrochemical Detection’. Nuclear Medicine and Biology: 37 33 (3) p. 441-447. 38

http://adsabs.harvard.edu/cgi-bin/author_form?author=Meeder,+R&fullauthor=Meeder,%20R.%20J.%20J.&charset=UTF-8&db_key=GEN

http://adsabs.harvard.edu/cgi-bin/author_form?author=Jaffray,+D&fullauthor=Jaffray,%20D.%20A.&charset=UTF-8&db_key=GEN

http://adsabs.harvard.edu/cgi-bin/author_form?author=Munro,+P&fullauthor=Munro,%20P.&charset=UTF-8&db_key=GEN


of 103

NEMA (2004) National Electrical Manufacturers Association. NU3-2004: Performance 1 Measurements and Quality Control Guidelines for Non-Imaging Intra-operative Gamma Probes. 2 Washington: National Electrical Manufacturers Association. 3

NEMA (2007a) National Electrical Manufacturers Association. NU 1-2007: Performance 4 Measurements of Gamma Cameras. Washington: National Electrical Manufacturers Association. 5

NEMA (2007b) National Electrical Manufacturers Association. NU 2-2007: Performance 6 Measurements of Positron Emission Tomographs. Washington: National Electrical Manufacturers 7 Association. 8

NEXT (1978) Nationwide Evaluation of X-Ray Trends. US Dose Surveys 1955-1975, HEW 9 Publication FDA. Rockville: Bureau of Radiological Health. 10

Njeh, C.F., Fuerst, T., Hans, D., Blake, G.M., and Genant, H.K. (1999) ‘Radiation exposure in bone 11 mineral density assessment’. Appl Radiat Isot: 50 (1) p. 215-36. 12

Nookala P. K. (2001) Modification of CT Quality Assurance Phantom for PET/CT Alignment and 13 PET Resolution. PhD thesis. Jawaharlal Nehru Technological University [Online]. Available at 14 http://etd.Isu.edu/docs/available/etd-04132005-163806/unrestricted/Nookala thesis.pdf (Accessed: 15 30 September 2009) 16

O'Connor, U., A. Dowling, Gallagher, A., Gorman, D., Walsh, C., Larkin, A., Gray, L., Devine, M., 17 and Malone, J.F. (2008). ‘Acceptance testing of fluoroscopy systems used for interventional 18 purposes’. Radiat Prot Dosimetry: 129 (1-3) p. 56-8. 19

Papp, J. (1998) Quality Management in the Imaging Sciences. St Louis: Mosby Inc. 20

Parsons, D.M., Yongmin, K. and Haynor, D. (1995) ‘Quality Control of Cathode-Ray Tube Monitors 21 for Medical Imaging Using a Simple Photometer’. Journal of Digital Imaging: 8 (1) p. 10-20. 22

Pearson, D., Cawte, S.A., and Green, D.J. (2002) ‘A comparison of phantoms for cross-calibration 23 of lumbar spine DXA’. Osteoporos International: 13 (12) p. 948-54. 24

RCR (2002) Royal College of Radiologists. Clinical Radiology and Electronic Records. RCR Report 25 BFCR(02)3. London: The Royal College of Radiologists. 26

Samei, E., Badano, A., Chakraborty, D., Compton, K., Cornelius, C., Corrigan, K., Flynn, M.J., 27 Hemminger, B., Hangiandreou, N., Johnson, J., Moxley, M., Pavlicek, W., Roehrig, H., Rutz, L., 28 Shepard, J., Uzenoff, R., Wang, J. and Willis, C. Assessment of Display Performance for Medical 29 Imaging Systems, Report of the American Association of Physicists in Medicine (AAPM) Task 30 Group 18, Medical Physics Publishing, Madison, WI, AAPM On-Line Report No. 03, April 2005. 31

Sandborg, M., Dance, D.R., Carlsson, G.A. and Persliden, J. (1993). ‘Monte-Carlo study of grid 32 performance in diagnostic-radiology – Factors which affect the selection of tube potential and grid 33 ratio’. Brit. J. Radiol. 66 p. 1164-1176. 34

Sandborg, M., Dance, D.R., Carlsson, G.A. and Persliden, J. (1994). ‘Monte-Carlo study of grid 35 performance in diagnostic-radiology – Task-dependent optimization for screen-film imaging’. Brit. J. 36 Radiol. 76 p. 76-85. 37

SBPH-BVZF (2008) Belgian Hospital Physicists Association. Belgian Protocol for Annual Quality 38 Control. SBPH. 39


of 103

SEFM-SEPR (2002) Sociedad Española de Física Médica and Sociedad Española de Protección 1 Radiológica. Protocolo Español De Control De Calidad En Radiodiagnóstico (Aspectos técnicos) 2 Revision 1. Madrid: EdiComplet. 3

Seibert, J. A. (1999) Film Digitizers and Laser Printers. AAPM Medical Physics Monograph No. 25, 4 p.107-133. 5

Sheahan, N.F., Dowling, A., O’Reilly, G. and Malone, J.F. (2005) Commissioning And Quality 6 Assurance Protocols For Dual Energy X-Ray Absorptiometry (DEXA) Systems. Radiat Prot 7 Dosimetry, 117 (1-3) p. 288-290. 8

Siegel, J. A., Zimmerman, B.E., Kodimer, K., Dell, M.A., and Simon, W.E. (2004) ‘Accurate Dose 9 Calibrator Activity Measurement of 90Y- Ibritumomab Tiuxetan’. The Journal of Nuclear Medicine 45 10 (3) March, p. 450-454. 11

SMPTE (1986) Society of Motion Picture and Engineers. ‘SMPTE recommended practice 12 specifications for medical diagnostic imaging test pattern for television monitors and hard copy 13 recording cameras, RP-133’. SMPTE J. p. 693-695. 14

Reiner, B.I., Siegel, E.L. and Carrino, J.A. (eds.) (2002). Quality Assurance: Meeting the challenge 15 in the Digital Medical Enterprise. Great Falls: Society for Computer Applications in Radiology. 16

Toroi, P., Komppa, T. and Kosunen, A. (2008) ‘A tandem calibration method for kerma–area product 17 meters’. Phys. Med. Biol., 53, p. 4941-4958. DOI: 10.1088/0031-9155/53/18/006 (Accessed 30 18 September 2009) 19

Trueblood, J.H. (1993) Radiographic film digitatization. Digital Imaging, AAPM Medical Physics 20 Monograph nº 22, p. 99-122. 21

Walsh, C., Gorman, D., Byrne, P., Larkin, A, Dowling, A. and Malone, J.F. (2008) ‘Quality 22 Assurance of computed and digital radiography systems’. Radiat Prot Dosimetry: 129 (1-3) p.271-23 275. 24

Wengenmair, H., and Kopp, J. (2005) Gamma Probes for Sentinel Lymph Node Localization: 25 Quality Criteria, Minimal Requirements and Quality of Commercially Available Systems. 26 http://www.sln-kompetenzzentrum.de/gammaprobes.pdf (Accessed: 30 September 2009) 27

Yu, S. K., Ma, K.M., Wong, K.N., Leung, J. and Leung, L.C. (2005) ‘Intraoperative Gamma Probe for 28 Sentinel Node Localisation: Evaluation Study’. J HK Coll Radiol: 8 p. 40-48. 29

Zoetelief, J., Schultz, F. W., Kottou, S., Gray, L., O'Connor, U., Salat, D., Kepler, K., Kaplanis, P., 30 Jankowski, J., Schreiner, A. and Vassileva, J. (2008). ‘Quality Control Measurements for 31 Fluoroscopy Systems in Eight Countries Participating in the SENTINEL EU Coordination Action’. 32 Radiat Prot Dosimetry: 129 (1-3) p. 237-43. 33

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ACKNOWLEDGEMENTS

Coordinator: Dr Keith Faulkner Diagnostic Radiology Lead: Prof Jim Malone Nuclear Medicine Lead: Dr Stelios Christofides Radiotherapy Lead: Prof Stephen Lillicrap

Contributors

Diagnostic Radiology

Dr Steve Balter

Dr Norbert Bischof

Dr Hilde Bosmans

Ms Anita Dowling

Aoife Gallagher

Remy Klausz

Dr Lesley Malone

Ian (Donald) Mclean

Dr Alexandra Schreiner

Dr Eliseo Vano

Colin Walsh

Dr Hans Zoetelief

Nuclear Medicine

Dr Inger-Lena Lamm

Dr Soren Mattsson

Radiotherapy

Prof Patrick Horton

Dr Inger-Lena Lamm

Dr Wolfgang Lehmann

Reviewers

Dr Tamas Porubszky

Mr S. Szekeres

Markku Tapiovaara

Kalle Kepler

Koos Geleijns

Simon Thomas PhD FIPEM

Geraldine O’Reilly

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