Health Products (Medical Devices)(Amendment) Regulations 2012

NO. S 140

First published in the Government Gazette, Electronic Edition, on 4th April 2012 at 5.00 pm.

HEALTH PRODUCTS ACT(CHAPTER 122D)

HEALTH PRODUCTS(MEDICAL DEVICES) (AMENDMENT)

REGULATIONS 2012

In exercise of the powers conferred by section 72 of the HealthProducts Act, the Health Sciences Authority, with the approval ofthe Minister for Health, hereby makes the following Regulations:

Citation and commencement

1. These Regulations may be cited as the Health Products (MedicalDevices) (Amendment) Regulations 2012 and shall come intooperation on 5th April 2012.

New regulation 10A

2. The Health Products (Medical Devices) Regulations 2010(G.N. No. S 436/2010) (referred to in these Regulations as theprincipal Regulations) are amended by inserting, immediately afterregulation 10, the following regulation:

‘‘Exception for certain Class A medical devices10A. Without prejudice to any other provision in this Division,

the prohibition in section 15(1) of the Act against the supply ofan unregistered health product shall not apply to the supply ofa Class A medical device —

(a) which is listed in the first column of the Sixth Schedule;(b) which is not of or does not bear a description or

an intended purpose which is substantially differentfrom the description or intended purpose described inthe second column of that Schedule; and

(c) which is not intended to be supplied in a sterile state.’’.

1 S 140/2012

Amendment of regulation 11

3. Regulation 11(1) of the principal Regulations is amended —(a) by deleting the words ‘‘1st September 2011’’ in sub-paragraph

(b)(vi) and substituting the words ‘‘1st December 2011’’;(b) by deleting the word ‘‘and’’ at the end of sub-paragraph (d);

and(c) by deleting the full-stop at the end of sub-paragraph (e) and

substituting the word ‘‘; and’’, and by inserting immediatelythereafter the following sub-paragraph:

‘‘(f) the retail supply, at any time, by a retail supplier ofan unregistered Class A or B medical device thatthe retail supplier has taken possession of on or after10th August 2010 but before 5th April 2012.’’.

New Sixth Schedule

4. The principal Regulations are amended by inserting, immediatelyafter the Fifth Schedule, the following Schedule:

‘‘SIXTH SCHEDULERegulation 10A

First column Second column

Device identifier Description or intended purpose

1. Adhesive bandage A piece of fabric or plastic material (not a strip)that is applied to a part of the body with apressure-sensitive adhesive. It may or may notinclude an absorbent pad. It is used to cover andprotect intact skin or wounds, to approximate theskin edges of a wound, to support an injured partof the body, or to secure objects to the skin. Thisis a single-use device.

2. Adhesive strip A small, narrow flexible band (of fabric, plastic,paper or other material) coated on one side witha pressure-sensitive adhesive, used to cover andprotect intact skin or wounds or approximate theedges of superficial wounds or fix dressings toskin. The device may include an adhesive padand have qualities such as hypoallergenic orwaterproof. The device is usually supplied in pre-cut sizes or shapes. This is a single-use device.

2S 140/2012

SIXTH SCHEDULE — continued



3. Adhesive tape A very long and narrow flexible band (of fabric,plastic, paper or other material) coated on oneside with a typically pressure-sensitive adhesive,used to cover a surface (e.g. small wound), fixa dressing, or bind/attach objects (e.g. a venflonto a patient’s body part, an orthopaedic cast).The device may also be applied in several layers,one overlapping the other, to cover and exertpressure on a body part (e.g. a limb). The devicemay have additional properties (e.g. waterproof,hypoallergenic) and is typically supplied in rolls.This is a single-use device.

4. Adhesive tape remover A solvent material designed to remove adhesivetape and its residue from the skin or othersurfaces. This is a single-use device.

5. Applicator, absorbenttipped

A device used for making local applications toany accessible body surface. It is typicallydesigned as a slender rod of wood, flexible metalor a synthetic material, to which is attached anon-sterile absorbent tip at one end. This is asingle-use device.

6. Nasal aspirator, manual A portable, hand-held, manual suction devicedesigned to enable gentle suction and clearing ofexcessive mucus from the nasal passages tofacilitate easier breathing. It is available in avariety of forms including a compressible bulbwith a tube that is inserted into the nares, or asyringe with a small bulb at its distal end that isapplied to the nasal opening.

3 S 140/2012




7. Ice bag A flexible container (a bag) designed to be filledwith ice to provide dry cold therapy to a limitedexternal surface area of the body. It is typicallymade of plastic or rubber materials with adetachable cap that can be threaded or fixed tothe bag once it is filled with ice. It may include aholder or attachments to facilitate fixing orholding the device in place against the bodysurface of the patient. It can be used to alleviatepain and/or promote healing in minor injuries ofthe body, or for application around the neck orlimbs.

8. Bandage, self-adherent A flexible piece, strip, or roll of fabric or plasticmaterial that is applied to (typically wrappedaround) a part of the body to secure a dressing,maintain pressure over a compress, or immobilisea limb or other body part. This is a single-usedevice.

9. Bandage, clavicle A strip or roll of fabric or webbed material thatis wrapped around the shoulder girdle tomaintain fixation and longitudinal extension ofthe clavicle during a period of treatment. This isa single-use device.

10. Bandage, elastic An elasticised fabric (e.g. polyamide, lycra) usedto provide support or local pressure to a part ofthe body, especially a joint, while allowingmovement. It may have various configurations(e.g. long flat strip, tubular) to accommodatevarious body parts (e.g. ankles, knees, wrists,neck). This is a single-use device.

11. Bandage, gauze A piece or strip of fabric made of open weavecotton or rayon fibres and of differing degrees offineness used to cover and protect wounds. Thisis a single-use device.

12. Bandage, gauze, roller A long, layered gauze supplied in rolls that isused to bandage heads, limbs and wounds thatare difficult to dress (e.g. burns, plastic surgeryor orthopaedic wounds). This is a single-usedevice.

4S 140/2012




13. Bandage, traction A large strip of fabric or plastic material used toassist in exerting desirable tensile (pulling) forceson the body. This is a single-use device.

14. Sitz bath A tub that is filled with heated water andintended for use in external hydrotherapy torelieve pain or pruritus and to accelerate thehealing of inflamed or traumatised tissues of theperianal and perineal areas. The patientimmerses only the hips and buttocks, keeping thelegs outside of the tub. It is typically used tomaintain patient hygiene and to alleviate painand discomfort caused by haemorrhoids, uterinecramps, labour and/or other diseases of thepelvic, abdominal and perineal area (e.g.prostate, bladder, bowel, vaginal disorders). Thisis a non-active medical device.

15. Bed, hospital A device upon which a patient rests or sleeps, orupon which a patient may be treated. It is usedin hospitals, institutions and home care and isused in conjunction with a patient’s admissionand treatment, or for the disabled or infirm.

16. Bed, general-purpose,manually-operated

A mechanically-designed bed to be used as ageneral-purpose patient bed in hospital wardswith manual mechanisms to adjust the height andsurface contour of the bed. This device mayinclude movable and latchable side rails.

17. Bed, general-purpose,hydraulically-powered

A bed designed to be used as a general-purposepatient bed in hospital wards with a hydraulicmechanism to adjust the height and surfacecontour of the bed. This device may includemovable and latchable side rails.

18. Bed, general-purpose,electrically-powered

A bed designed to be used as a general-purposepatient bed in hospital wards and which iselectrically powered (motorised), providing thepatient/nursing staff with touch buttonadjustment possibilities.

5 S 140/2012




19. Bedpan, fracture A device used by a bedridden patient asreceptacle for urine and faeces and which isdesigned to be used by a patient whose hips havebeen plastered. This device is reusable after theappropriate cleaning procedure has been done.

20. Bedpan, general-purpose A device used by a bedridden patient asreceptacle for urine and faeces. This device isreusable after the appropriate cleaning procedurehas been done.

21. Abdominal binder A strip or roll of fabric or plastic materialapplied to the abdomen to support relaxedabdominal walls.

22. Ankle binder A strip or roll of fabric or plastic materialdesigned to support the ankle joint.

23. Breast binder A strip or roll of fabric or plastic materialdesigned to support the breasts.

24. Chest binder A strip or roll of fabric or plastic materialdesigned to support the ribs and chest.

25. Binder, sternum A strip or roll of fabric or plastic materialdesigned to support the sternum.

26. Wrist binder A strip or roll of fabric or plastic materialdesigned to support the wrist joint.

27. Blanket, rescue A large piece of fabric-material blanket speciallydesigned to keep a patient warm and/or toprevent the further loss of body heat in anemergency situation.

28. Bite block A device inserted into a patient’s mouth tomaintain oral patency during an endoscopicprocedure primarily to protect the endoscope,introduced via the mouth, from the patient’snatural tendency to bite down on the instrument.The device will also protect the tongue and teethof the patient during endoscopy. This is a single-use device.

6S 140/2012




29. Adaptor, blood collectingtube, reusable

A non-sterile reusable device used to attach andhold a venous access device (i.e. needle, bloodcollection set) during venipuncture and toconnect these devices to the blood collectiontube.

30. Blood collection tray A device intended to hold syringes and otherapparatus needed for blood collection.

31. Stripper, blood tubing A device specifically designed to strip, crimp andcut tubing in the preparation of blood segmentsfrom the blood collection and processingprocedures.

32. Tube, blood collecting,open

A non-sterile device designed as a tube which isused during the collection of blood. It is open-ended, allowing blood to fill the tube from, forexample, a tubing that has been inserted. Thetube may or may not be sealed using a cap orplug. This is a single-use device.

33. Tube, blood collecting,sealed, evacuated

A non-sterile device designed as a tube which isused with a blood collection tube adaptor anda blood collection needle to draw blood. Thisdevice is a presealed tube which has beenpartially evacuated. The vacuum will make thetube fill with blood. This is a single-use device.

34. Board, arm A firm device in which a patient’s arm is placedfor stabilisation to maintain the patency of anintravascular catheter (e.g. those connected to anintravenous or intra-arterial line). It is typicallyconstructed of expanded polystyrene with aplastic coating and can be straight or curved toaccommodate the patient’s arm/wrist.

35. Board, cardiaccompression

A flat, rigid device that is placed under a patientto instantly give the necessary support requiredfor the application of cardiopulmonaryresuscitation. This device is typically suitable foruse when an acute situation has arisen and thepatient is lying in his bed.

7 S 140/2012




36. Board, spinal A flat, stiff device placed on a stretcher toensure spinal immobilisation when a spinal injuryis suspected.

37. Bottle, heating/cooling A flexible container, typically with a relativelynarrow neck, that is usually filled with either hotor cold water or ice for the purpose of applyingheat or cold therapy to an area of the body.

38. Contact lens case A container designed for the storage of contactlenses when the lenses are not being used. Thecontainer is composed of chemically inertmaterial(s).

39. Chair, bath/shower A device designed to be sat upon by a personwho is either bathing, showering, or using somewashing facility where there is a need to sit, suchas because the person is disabled or infirm, orbecause it is part of medical treatment.

40. Chair, blood donor A device used to position the patient in such amanner that a technician/nurse has easy access tothe patient’s arm for drawing blood. The armboard, that is attached to the chair, has lateraland height adjustments so that the patient’s armcan be positioned in a location that is easilyaccessible to whoever is drawing the bloodsample. This chair can typically be tilted/movedso that the patient lies in a reclining position.

41. Chair, examination/treatment

A device used to position the patient in a sitting,semi-sitting or reclined posture for easy accessand patient comfort during an examination,treatment, or surgical intervention.

42. Chair, toilet A chair designed with a toilet-like seat thatallows an immobilised person/patient to utilise astandard stationary toilet without leaving thechair.

8S 140/2012




43. Chair, MRI system A chair or stool specifically designed to supportand position a patient during an examinationinvolving the use of a diagnostic magneticresonance imaging (MRI) system. For MRIsystem compatibility, these chairs/stools are madeof ferromagnetically inactive materials.

44. Charger, battery A mains electricity (AC-powered) devicedesigned to supply an electrical charge to therechargeable batteries or battery pack of amedical device, restoring the batteries or batterypack to an appropriate working condition. Thisdevice is typically connected to the building’smains electricity power supply and can be usedto charge the batteries either by themselves(removed from their parent device) or whilstthey are still inside the parent device (in situ),e.g. a defibrillator, an ophthalmoscope, anotoscope. This device usually has current andvoltage controls to meet the charge needs ofdifferent types of batteries.

45. Chart, eye, Amsler grid An ophthalmic device that consists of a series ofcharts with grids of different sizes that are heldat a distance of 30 cm from the patient andintended to rapidly detect central and paracentralirregularities in the visual field.

46. Chart, eye, colourdiscrimination

An ophthalmic chart with coloured figuresprinted on coloured backgrounds, used in testingcolour vision.

47. Chart, visual acuity An ophthalmic chart imprinted with block lettersor other symbols in gradually decreasing sizes,identified according to distances at which theyare ordinarily visible; used in testing visualacuity. Such charts are often combined in a boxwhere the individual letters or symbols areselected and highlighted by the optician/doctorwith background electrical lighting.

9 S 140/2012




48. Syringe, highperformance/calibration,liquid/gaschromatography

A dedicated syringe used for injecting smallvolumes of accurately measured amounts ofliquid or gas into a chromatograph system, suchas for calibration or reference. This device istypically made of a glass cylinder with a steelplunger and made to high tolerances of accuracy.It is a medical device that is intended by theproduct owner for use as an in vitro diagnostic(IVD) product.

49. Indicator, cellulosefluorescent, TLC

For use in thin layer chromatography. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

50. UV light, TLC For use in thin layer chromatography. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

51. Indicator, aluminafluorescent, TLC


52. Indicator, silica gelfluorescent, TLC


53. Plate, alumina, TLC For use in thin layer chromatography. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

54. Papers, ion exchange For use in ion exchange chromatography. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

55. Resins, ion exchange,liquid chromatography

For use in ion exchange chromatography. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

10S 140/2012




56. Centrifuge, laboratory A device that is a laboratory centrifuge used toseparate the components of suspensions by theapplication of centrifugal force. It typicallyconsists of an electrically-powered drive unit witha vertical shaft and horizontal rotor attached tothe upper end. This device is intended tocentrifuge patient samples (e.g. body fluids)either alone or after the addition of reagents orother additives before measuring analytes. It istypically a low-speed (up to 6,000 rpm) ormedium-speed (up to 12,000 rpm) machine. It isa medical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

57. Centrifuge, ultra A device that is a laboratory centrifuge used toseparate the components of suspensions by theapplication of centrifugal force. It typicallyconsists of an electrically-powered drive unit witha vertical shaft and horizontal rotor attached tothe upper end. This device is a specialisedcentrifuge that processes relatively small volumesof sample at very high speeds, typically up to100,000 rpm and RCF 800,000 xg. It is a medicaldevice that is intended by the product owner foruse as an in vitro diagnostic (IVD) product.

58. Cover, microscope slide A device or material used as a physical barrier toprotect the surface of a microscope slide uponwhich a sample has been placed from the effectsof mechanical and/or environmental exposure.This is a single-use device. It is a medical devicethat is intended by the product owner for use asan in vitro diagnostic (IVD) product.

59. Slide, microscope A device, typically a thin flat piece of glass ofgiven dimensions, whereupon samples (e.g.blood, tissue) can be placed for analysis, usuallyunder a microscope. This is a single-use device. Itis a medical device that is intended by theproduct owner for use as an in vitro diagnostic(IVD) product.

11 S 140/2012




60. Petri dish processor A laboratory instrument that automaticallyprocesses petri dishes, feeding them from amagazine and filling them with a given quantityof substance, e.g. agar (a gelatine-like substancederived from seaweed used as a stabiliser and fornutrition) prior to the production of micro-organism cultures, for diagnostic purposes. Thiscan be used together with an agar steriliser. It isa medical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

61. Pipette, electronic/manually-operated

A device typically used in the laboratory totransfer discrete and consistent volumes of liquidsubstances, e.g. into a test tube or the wells of amicrotitre plate. This device can operatemechanically, electronically, or through manualinduction. The device may be factory pre-set todeliver a given volume, or may have user-selectable volumes within a useful volume range.It includes the pipette tips, safety mouthpieceand shield. It is a medical device that is intendedby the product owner for use as an in vitrodiagnostic (IVD) product.

62. Incubator, laboratory A device designed for use in a laboratory settingto provide controlled conditions for theincubation of biological and chemical materials.It will typically maintain a desired environmentof, for example, temperature, gas concentrationsor humidity. It is a medical device that isintended by the product owner for use as an invitro diagnostic (IVD) product.

63. Inoculating loop A device consisting of a slender handle and anattached wire loop used to gather and holdspecimen material (e.g. bacterial growth colonies)for the purpose of inoculating a culture medium(e.g. agar or broth). It is a medical device that isintended by the product owner for use as an invitro diagnostic (IVD) product.

12S 140/2012




64. Mixer, laboratory A device, typically used in the laboratory, for themixing of 2 or more components by using a slowstirring/blending movement. It is a medicaldevice that is intended by the product owner foruse as an in vitro diagnostic (IVD) product.

65. Sample processingsystem

An automated group of devices without analysers(e.g. robotic conveyors, handlers) controlled by acomputer system used to alternate and treatclinical samples in preparation for analysis. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

66. Sample alternatingsystem

An automated group of devices without analyserscomposed of robots/conveyors and a computercontrol system used to rotate clinical samples forprocessing and analysis. It is a medical devicethat is intended by the product owner for use asan in vitro diagnostic (IVD) product.

67. Sample processor An instrument without analysers used toautomatically prepare a clinical sample foranalysis. It is a medical device that is intended bythe product owner for use as an in vitrodiagnostic (IVD) product.

68. Sample processor,immunoassay

An instrument or apparatus intended tohomogenise a sample taken from human tissueand to prepare a portion of the sample foranalysis by immunoassay analysers. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

69. Sample tube vacutipinserting device

A laboratory instrument that introduces smalltube-like tips (vacutips) into the rubber corks/plugs of sample tubes. This procedure willprevent the evaporation of the sample, andsampling (automatic or manual) can easily beperformed through the inserted tip. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

13 S 140/2012




70. Shaker, laboratory A device, typically used in the laboratory, thatshakes or stirs samples/mixtures with a rapid andforceful movement. It is specially used to preventsubstances comprising different components fromseparation or sedimentation because of theirdifferent densities. It is a medical device that isintended by the product owner for use as an invitro diagnostic (IVD) product.

71. Thermostat, laboratory A device used in laboratories to regulate thetemperature of various media in association witha parent device (e.g. water in water baths). It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

72. Washer A device used in the clinical laboratory to washloosely adherent cells or to wash away residualsbefore diagnostic testing. It may have flexiblewashing options from simplicity of operation todigitally controlled aspiration and dispensingpumps. It is a medical device that is intended bythe product owner for use as an in vitrodiagnostic (IVD) product.

73. Clip, nose A device used to help prevent air movementthrough the nares. The device is typicallyconstructed of plastic with rubber or foam tipsand is used during pulmonary function studies tohelp ensure that airflow is conducted through themouthpiece for accurate measurements.

74. Clip, spectacle,ophthalmic

A device intended to hold prisms, spheres,cylinders, or occluders on a trial frame or set ofspectacles during vision testing.

75. Collector, general A non-sterile small container for medicaltreatment purposes or intended for the purposeof short-term storage and/or transportation, tocollect fluids, gas or other materials from thehuman body. This may also be for specimen orsample purposes.

76. Collector, sweat A non-sterile container used for collecting sweattypically for specimen or sample purposes.

14S 140/2012




77. Collector, urine A non-sterile small container used for collectingurine to obtain a specimen for analysis. This is asingle-use device.

78. Compression dressing An elastic material that is designed to compressa local area (e.g. to stop bleeding, preventoedema or provide support for varicose veins orostomy aids).

79. Compression garment An elastic material that is contoured to fit overand apply pressure to one or more specific bodyparts (e.g. thighs, hips, buttocks), and is typicallyused after an invasive procedure (e.g.liposuction). In the case of significantsubcutaneous tissue removal (e.g. fat removalafter liposuction), the device may aid in thereadjustment of overlying skin. This is a reusabledevice.

80. Sterilisation container A device used to hold surgical instruments,typically units (e.g. surgical powered drills, sawsand their hoses) but also other instrumentsduring sterilisation and for their subsequentstorage. The container is permeable in order toallow moisture to escape from within after thesterilisation process is finished, whilst protectingthe contents from being contaminated. It mayhave features such as expiry date, sterilebreathing filter or stacking abilities.

81. Digital imaging cassette A device (e.g. a cassette or barrier envelope)used in medical imaging applications to hold andshield an attached storage phosphor screen fromexposure to room light during transport andinsertion into a diagnostic imaging X-ray systemor a computed radiography scanner, in theprocess of producing a digital image of a patientradiation pattern.

15 S 140/2012




82. X-ray film cassette,manual

A device used in medical imaging applications toshield X-ray film from exposure to room lightduring transport and insertion into a diagnosticimaging system, film formatter or film processor.It is typically designed for use with a particularimaging system or image formatting unit andconsists of a plastic or metal housing withremovable metal or plastic inserts. Some filmcassettes used in X-ray applications canincorporate an X-ray grid into the cassettedesign.

83. Cotton ball A spherical mass of cotton or man-made fibresused as a swab to apply medications to orremove liquid from various parts of the body.

84. Cotton roll, general-purpose

A device usually made of medical cotton orsometimes man-made fibres that has a general-purpose use throughout hospitals and other areasof the healthcare sector.

85. Cover, thermometer A device used as a physical barrier for athermometer to prevent cross-contaminationbetween patients and/or environmental exposure.This is a single-use device.

86. Absorbent point, dental A non-medicated absorbent point used inendodontic procedures. This is a single-usedevice.

87. Mixer, dental, amalgam A dental amalgamator is a device intended tomix chairside, by shaking, mainly amalgamcapsules containing mercury and dental alloyparticles immediately before application to theteeth of the patient during dental procedures.

88. Articulating paper A strip or sheet of suitable material coated withpigment and used for marking areas of contactbetween opposite teeth, restorations orappliances. This is a single-use device.

16S 140/2012




89. Camera, dental,intra-oral

A camera specially designed for use duringdental surgery to obtain still picturedocumentation of surgical procedures and tophotograph pathologies. This generic devicegroup includes Polaroid, digital and photographicfilm cameras. This camera is not meant for adiagnostic purpose.

90. Chart, dental, colourdiscrimination

A device used to determine the correct shade(colour) of filling materials, artificial crowns andteeth for matching to those of the patient.

91. Cotton roll, dental A device formed as a small, short, cotton rollthat is used as a saliva absorber and intended toabsorb moisture from the oral cavity duringdental procedures. It is usually made of cottonand is disposable.

92. Cushion, dental A prefabricated or non-custom-made disposabledevice that is intended for use to improve the fitof a loose or an uncomfortable denture.

93. Dental teeth protector A curved device designed to fit over the upperand lower sets of teeth to protect them fromdamage during dental procedures. Suchprotection can be required when the patient isresisting the dental treatment by clenching histeeth which can be damaged against the metal orplastic materials of the dental instruments beingused, and/or if the patient has bad teeth that aresusceptible to inadvertent damage.

94. Dental ring A device used to hold a matrix band and wedgein place around the tooth.

95. Dental wedge A dental device that is positioned wedge-like atthe interdental and cervical area of the teethduring routine intra-oral dental procedures. It isused to slightly separate the teeth during theplacement of a filling material, or to stabilise andsupport other devices (e.g. a matrix band or arubber dam).

17 S 140/2012




96. Forceps, dental A hand-held dental instrument used in themouth for different gripping applications. This isa single-use device.

97. Light, dental,polymerisation activator

An electrically-powered lamp used to initiate thepolymerisation of dental resin-based materials.The source for the activation should beultraviolet light. It is used for curing of polymer-based materials in the laboratory.

98. Light, dental, intra-oral A dedicated light-conducting system with a verysmall dimension at the light delivery enddesigned for dental use and to be introduced intothe oral cavity. It delivers light using fibre opticcables. The device is typically attached to adental hand piece and is intended to directlyilluminate a patient’s oral structures.

99. Light, dental, general-purpose

A dedicated light designed for general-purposedental use that delivers intense focused lightingto the dental operating, examination orprocedure site, which usually is the oral cavity.

100. Matrix band/strip, dental A matrix band or strip comprising strongmaterial (typically stainless steel or transparentpolyester) or a short tube that is used to form amould around a tooth for the insertion ofrestorative materials. The device is held snuglyaround the tooth by a matrix retainer ortensioned around the tooth using a dedicatedmechanical tensioning device. The matrix strip,retainer and tensioner may be supplied togetheror separately.

101. Mouth guard, preformed A prefabricated device designed to protect theteeth, bones, and tissues of the mouth, from theeffects of grinding/clenching of teeth (e.g.bruxism). It is typically made of standard,preformed materials or items for adaptation/direct insertion in the mouth.

102. Mirror, dental, hand-held A dental instrument for intra-oral inspection,generally comprising the mirror head and themirror handle.

18S 140/2012




103. Placers, dental Elastic placers provide an elastic hook on oneend and a pusher on the other end to removedental elastics.

104. Retractor, dental A dental instrument intended to be used tomanually displace soft tissues (e.g. cheeks, lips,tongue) of the oral cavity to improve theirvisualisation and access, and to afford themprotection during oral surgical procedures. Thisis a single-use device.

105. Scaler, dental, manual A hand-held dental instrument for removingcalculus and other accretions from the surface ofteeth during dental cleaning and periodontaltherapy. This is a single-use device.

106. Aligner tray seater A device placed between the upper and lowersets of teeth and bitten down on, or chewed, toseat aligners in the right position.

107. Tray, dental A device intended to hold solutions, gels andfoams for dental treatment.

108. Impression tray, dental A device intended to hold, support and controlthe impression material(s) used in making adental impression (e.g. of a patient’s teeth oralveolar process (bony tooth sockets) to producethe structure of a patient’s teeth and gums). Thisdevice is typically preformed (e.g. horseshoeshaped) and made of metal or plastic materials.

109. Depressor, tongue An instrument intended to displace the tongue tofacilitate examination of the surrounding organsand tissues.

110. Surgical drape, general-purpose

A non-sterile (usually sterilised before use)protective covering made of natural or syntheticmaterials, or both, designed to isolate a site ofsurgical incision or a surgical field fromcontamination (e.g. microbial, substance) invarious clinical settings (e.g. in an operatingroom or a catheterisation laboratory). The devicemay also be used to protect a patient from heator flame during a surgical procedure.

19 S 140/2012




111. Hammer, percussion A metal, usually stainless steel, instrumentcomprising a handle, shaft and head, used todeliver a force to the body to test reflexes. Thehandle is designed to fit into the palm of thehand and is usually round, tapering distally into ashaft which terminates at the head. A percussionhammer head comes in various shapes. Someheads are fitted on one or both ends with amaterial (e.g. rubber or plastic, of various shapesto absorb the shock of the impact). It is alsopossible for the entire head to be made of rubberor plastic. A percussion hammer is used inneurological examinations.

112. Bath, paraffin, laboratory A laboratory device used to heat paraffin wax sothat it can be used in the fixation of laboratoryspecimens (e.g. tissue biopsies). It is a medicaldevice that is intended by the product owner foruse as an in vitro diagnostic (IVD) product.

113. Bath, tissue flotation A water bath used in conjunction with amicrotome during the production of tissuespecimens. The tissue specimens float onto thesurface of the bath as they are sliced by theoperator of the microtome. This device istemperature controlled and is typically used inthe laboratory. It is a medical device that isintended by the product owner for use as an invitro diagnostic (IVD) product.

114. Cryo spray, histology A refrigerant (e.g. dimethyl ether and propane)typically contained in an aerosol dispenser andintended to be used in histology laboratories forfreezing tissue specimens in paraffin blocks forsectioning. It is a medical device that is intendedby the product owner for use as an in vitrodiagnostic (IVD) product.

20S 140/2012




115. Microtome blade A device that is a flat wedge-shaped blade thathas a cutting edge of extreme sharpness andwhich is mounted into a microtome used to cutmicro-slices of tissues that have been fixed, andusually impregnated with paraffin wax. Theresulting sections are mounted on glass slides forstaining then viewing by microscope. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

116. Microtome, rotary,sliding or ultra

An instrument used for cutting tissue samplesinto micro-slices in preparation for histologicalstudy (microscopic examination). Before cutting,the tissues are fixed (e.g. in paraffin wax,celloidin, plastic), and may be secured to asample block (a base). For cutting, the sample isheld by clamps and the microtome blade/knife ispassed over it. It is a medical device that isintended by the product owner for use as an invitro diagnostic (IVD) product.

117. Microtome, cryostat An instrument that consists of a microtomecontained in a temperature controlled cabinetcalled a cryostat. It is a medical device that isintended by the product owner for use as an invitro diagnostic (IVD) product.

118. Stain, microscopy An agent used to colour or refract the light of asample of tissue, cells, blood, or micro-organismsin preparation for light, electron or fluorescencemicroscopy for diagnostic purposes in clinicallaboratories. It is a medical device that isintended by the product owner for use as an invitro diagnostic (IVD) product.

21 S 140/2012




119. Tissue processor An instrument used in the laboratory for thepreparation of tissue specimens prior toexamination. It will typically utilise fixation (e.g.encapsulation in a paraffin wax), dehydration,and infiltration techniques to process the tissuesamples. This device may be of a manual, semi-automated or fully-automated design. It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

120. Freezer/dryer, laboratory A device typically used in the laboratory for theremoval of all moisture (water content) using theprocess of dry freezing. It is typically constructedas a chamber or receptacle into which the sampleor object is placed and the moisture is extracted.It is a medical device that is intended by theproduct owner for use as an in vitro diagnostic(IVD) product.

121. Immobiliser, ankle A non-rigid device, usually made of a fabric,used to temporarily render the ankle immovable(strait-jacket effect) to support the healing of aninjury or a surgical wound.

122. Immobiliser, arm A non-rigid device, usually made of a fabric,used to temporarily render the arm immovable(strait-jacket effect), typically at the shoulder andelbow, to support healing of an injury or asurgical wound.

123. Immobiliser, elbow A non-rigid device, usually made of a fabric,used to temporarily render the elbow immovable(strait-jacket effect) to support healing of aninjury or a surgical wound.

124. Immobiliser, infant A device, usually made of fabric and/or plasticmaterials, used to temporarily render parts of aninfant’s body (e.g. the arms and/or feet)immovable (strait-jacket effect) while the patientundergoes therapeutic or diagnosticinterventions. It will typically be used to preventthe patient from interrupting an intravenous (IV)infusion, pulling out a catheter, or interferingwith wound care.

22S 140/2012




125. Immobiliser, knee A rigid support used to temporarily render theknee immovable (strait-jacket effect), either pre-operatively or following injury or arthroscopy.

126. Immobiliser, shoulder A non-rigid device used to temporarilyimmobilise or limit abduction of the shoulderjoint (strait-jacket effect) to support healing ofan injury or a surgical wound. It is typically usedpost-operatively and for post-traumatic treatmentof injuries in the shoulder and upper arm areas(e.g. distortion/contusion, dislocation/luxation,post-operative support). It will typically consistof layered fabric, straps, buckles, fasteners andwill eliminate most of the work involved withbandaging.

127. Immobiliser, whole body A device, usually made of fabric and/or plasticmaterials, used to temporarily render thepatient’s whole body immovable (strait-jacketeffect) while the patient undergoes therapeutic ordiagnostic interventions.

128. Immobiliser, wrist A rigid support designed to temporarily renderthe wrist immovable (strait-jacket effect) astherapy for non-displaced fractures, strains,sprains, and muscle injuries of the wrist. It comesin a variety of sizes.

129. Irrigator, nasal A device designed to dispense a solutionintended to penetrate, clear, and clean the nasalpassages and sinus cavity. It typically includes anirrigation bottle/canister, and sometimes actuatortips and adaptors for various solution-deliveryapplications. The solution may be self-administered for post-operative, preventative orsymptomatic nasal care. The device does notinclude, or is not supplied together with,irrigation solution or medication.

130. Irrigation kit, eye A device that typically includes an applicationbottle, syringe or cup, used to flush the eye ofirritating particulates/chemicals, or to helpstimulate tired eyes. The device does not include,or is not supplied together with, irrigationsolution or medication.

23 S 140/2012




131. Knife, paraffin A dedicated knife designed to cut paraffinblocks. It will typically consist of a sturdy blademade of hard metal (e.g. beryllium copper) thatretains the heat well and a shank that ispermanently attached to a hand-held heat source.The heat, which may be regulated, penetratesinto the blade from the heat source (e.g.electrical) through the shank. This device is usedto cut/handle paraffin in clinical laboratories(histology and pathology embedding). It is amedical device that is intended by the productowner for use as an in vitro diagnostic (IVD)product.

132. Lens set, trial A set of ophthalmic lenses of various dioptricpowers intended to be handled or inserted in atrial frame for vision testing to determine therequired refraction.

133. Light, head-worn A device (a lamp) designed to be worn on anoperator’s head. It is mounted on a band orhelmet frame and situated on the user’s foreheadproviding a light directly into the field of visionduring surgical, diagnostic or therapeuticprocedures. The light typically consists of amagnifying lens, a reflector and a connection forthe fibreoptic cable to transfer cold-light orpower supply from a battery pack.

134. Light, surgical A device that provides a specialised light toilluminate a surgical site over a prolonged periodof time providing the surgeon(s) with optimalvisualisation of small, low-contrast objects atvarying depths or through small incisions. Inaddition to providing enough illumination andminimising the emission of heat to the site, thelight will reduce shadows and produce minimalcolour distortion, which helps the surgeonevaluate tissues and structures. It typicallyconsists of one or more light bulbs, which reflectthe light via reflectors or mirrors depending uponthe construction. This device will typically bepart of a light system comprising more than onelight head.

24S 140/2012




135. Light, examination,hand-held, battery-powered

A small hand-held battery-powered light used asa personal light source to provide light for localexamination, inspection and treatment of thepatient. It may be torch-like in design and canhave a magnifying lens to augment the lightingeffect. It will typically be found in anexamination room, doctor’s surgery or office, ona medical trolley or as part of an emergency kit.

136. Light, examination A device that provides light to illuminate the siteof examination or treatment of the patient. Ittypically consists of one or more light bulbswhich reflect the light via reflectors or mirrorsdepending upon the construction. This device hasa variety of uses and can be fixed (e.g. to aceiling or wall, or supported on a mount). It canalso be part of a light system comprising morethan one light head.

137. Light, ear A dedicated device designed to illuminate theear canal.

138. Loupe, binocular A system of lenses mounted onto a pair ofspectacles worn by the surgeon during surgicalintervention. These function as small telescopesand provide a magnified image of the workingfield. They can also be connected to an externallight source supplying light directly through thefield of vision.

139. Marker, skin A device used to make marks on the skin thatallow measurement or identification.

140. Mask, resuscitation A malleable cone placed over the nose andmouth to administer air to a patient duringcardiopulmonary resuscitation (CPR). The deviceis designed to replace mouth-to-mouthresuscitation, therefore avoiding cross-contamination. The device may include anairway, one-way valve or other component.

25 S 140/2012




141. Face barrier,resuscitation shield

A clear plastic sheet with a filter for mouth-to-mouth resuscitation. It does not provide absoluteprotection but reduces the risk of cross-contamination. The device does not include anairway, one-way valve or other component.

142. Mirror, ENT, hand-held An instrument with a surface sufficientlypolished to reflect enough undiffused light toform a virtual image of an object placed beforeit, for the purposes of ear/nose/throat (ENT)examinations. This mirror is mounted on a long,slender handle, and is held by the doctor whocan manipulate the mirror close to the site ofinterest.

143. Mirror, ENT, headband An instrument with a circular concave mirrorattached to a headband acting as a reflector thatis used to project a beam of deflected light to abody cavity (e.g. the nose or larynx) for thepurposes of ear/nose/throat (ENT) examinations.The doctor will wear this device on his head,place the reflector in front of one eye, and viewthe site through a small hole in the centre of thereflector.

144. Mirror, general or plasticsurgery

A device designed to be used to assistpractitioners during general or plastic surgerythat displays a virtual image of an object placedbefore it.

145. Mirror, headband,ophthalmic

An ophthalmic instrument with a circularconcave mirror attached to a headband used toproject a beam of light to allow examination ofthe eye and its associated structures.

146. Orthosis, shoulder/elbow/wrist/hand

An externally applied orthopaedic appliance orapparatus used to support, align or preventdeformities/injuries of the shoulder, elbow, wristand/or hand.

26S 140/2012




147. Orthosis, hip/knee/ankle/foot

An externally applied orthopaedic appliance orapparatus used to support, align or preventdeformities/injuries of the hip, knee, ankle and/orfoot. The device may be an articulated singleitem or a collection of compatible units specificfor various parts of the leg.

148. Orthosis, finger An externally applied orthopaedic appliance orapparatus used to support, align or preventdeformities/injuries of the finger.

149. Orthosis, footwear insert A specially designed footwear insert intended toprovide support for the base of the foot.

150. Orthosis, sacroiliac spine An externally applied orthopaedic appliance orapparatus that encompasses the sacroiliac spineregion of the trunk and is used to support orimmobilise deformities, fractures, sprains, orstrains of the spine.

151. Orthosis, thoracic spine An orthopaedic corset that encompasses thethoracic spine region of the trunk and is used tosupport or immobilise deformities, fractures,sprains or strains of the spine throughcompression of the abdomen.

152. Orthosis, cervicothoracicspine

An externally applied orthopaedic appliance orapparatus used to support or immobilisedeformities, fractures, sprains or strains of thecervicothoracic spine.

153. Orthosis, cervical spine An externally applied orthopaedic appliance orapparatus used to support or immobilisedeformities, fractures, sprains or strains of thecervical spine.

154. Orthosis, lumbosacralspine

An externally applied orthopaedic appliance orapparatus that encompasses the lumbosacralspine region of the trunk and is used to supportor immobilise deformities, fractures, sprains orstrains of the spine.

27 S 140/2012




155. Paper, recording A device prepared from a thin sheet of fibrousmaterial specially produced for recording theoutput of devices measuring physiologicparameters (e.g. electrocardiogram (ECG),electroencephalogram (EEG), or for ultrasoundimaging).

156. Intravenous pole A pole or rod with 2 or more hooked barsextending horizontally from its top from whichvarious fluid delivery devices (bags or bottles)can be suspended for the administration ofintravenous (IV) fluids or medication to thepatient. Commonly known as an IV pole or drippole, it can be a fixed or side-swinging,adjustable, vertical pole attached to a bed oroperating table, ceiling-mounted or, morecommonly, an independent floor-standing IVpole for bedside use. It may have wheels to allowpatient mobility.

157. Pressure alleviation pad A device designed to prevent pressure sores (e.g.bed sores or decubitus ulcers) occurring on theparts of the patient’s body which are prone tothis. It can equally be used as an underlay forthe patient when he/she is undergoing a longtreatment where the body is immobilised, or fordisabled, infirm persons who are confined tositting/lying positions. This device is usuallyconstructed as an underlay but can also beformed to accommodate the patient’s bodyshape, prominent or unprotected bony parts (e.g.as mattresses (both active and passive), pads orskins of different materials).

158. Finger protector A device intended to be used to protect aninjured finger from further trauma during thehealing process. It will typically be made ofdurable materials (e.g. plastic, rubber, reinforcedmetal).

28S 140/2012




159. Protector, foot A device designed to cover a part of the body, orto be worn over the foot to protect that part ofthe foot from friction against surfaces and knocksagainst objects. It is typically made of softpadded materials, and supplied in pre-cut sizesor shapes. It may have additional properties(e.g. waterproof, lubricating, hypoallergenic). Itis typically used by persons who suffer fromcommon foot ailments such as bunions, corns,blisters, calluses, ingrown toe nails, hammer toes,overlapping toes or spurs.

160. Projector, visual acuity An ophthalmic device, a kind of slide projector/beamer throwing block letters or other symbolson a screen/wall in gradually decreasing sizes,identified according to distances at which theyare ordinarily visible; and used in testing visualacuity.

161. Prosthesis, arm, non-active

An artificial substitute for a missing ordysfunctional arm used to restore some degree ofthe appearance and/or function of the normalanatomy. The device may be used as part of anupper limb prosthetic system. This is a non-activemedical device.

162. Prosthesis, ankle/foot,external, non-active

An artificial substitute for an ankle and/or foot,or foot part, used to restore some degree ofthe appearance and/or function of the normalanatomy. The device may be used as part of alower limb prosthetic system. This is a non-activemedical device.

163. Prosthesis, breast,external, non-active

An external device used to replace the breasttypically after a mastectomy, intended to restoresome degree of the appearance and/or functionof the normal anatomy. It is made of variousmaterials to simulate the appearance and textureof a breast and is typically fitted into a brassiere.This is a non-active medical device.

29 S 140/2012




164. Prosthesis, elbow,external, non-active

An artificial substitute for the upper limb missingat the elbow joint used to restore some degree ofthe appearance and/or function of the normalanatomy. The device moves as the result ofconnecting straps/cables or other mechanismpowered by the movement of body segments, orit moves as the result of a connection withanother functional limb component. The positionof the device may be maintained through amanual or automatic locking mechanism. Thedevice may be used as part of an upper limbprosthetic system. This is a non-active medicaldevice.

165. Prosthesis, hand, non-active

An artificial substitute for a missing hand used torestore some degree of the appearance and/orfunction of the normal anatomy. The devicemoves as the result of connecting straps/cables orother mechanism powered by the movement ofbody segments. The position of the device maybe maintained through a manual or automaticlocking mechanism. The device may be used aspart of an upper limb prosthetic system. Thedevice is external. This is a non-active medicaldevice.

166. Prosthetic hand range-of-motion aid, non-active

A device positioned on the arm and maintainedby friction used to increase the flexion range ofthe elbow allowing a prosthetic hand to reach theface of the wearer. This is a non-active medicaldevice.

167. Prosthesis, hip, external,non-active

An artificial substitute for a missing hip used torestore some degree of the function of the joint.The device is used as part of a lower limbprosthetic system. This is a non-active medicaldevice.

168. Prosthesis, knee,external, non-active

An artificial substitute for a missing knee used torestore some degree of the appearance and/orfunction of the joint. The device is used as partof a lower limb prosthetic system. This is a non-active medical device.

30S 140/2012




169. Prosthesis, leg, non-active

An artificial substitute for a missing ordysfunctional leg used to restore some degree ofthe appearance and/or function of the normalanatomy. The device may be used as part of alower limb prosthetic system. This is a non-activemedical device.

170. Prosthesis, shoulder,external, non-active

An artificial substitute for a missing shoulderused to restore some degree of the appearanceand/or function of the joint. The device may beused as part of an upper limb prosthetic system.This is a non-active medical device.

171. Prosthesis, wrist,external, non-active

An artificial substitute for a missing wrist used torestore some degree of the function of the joint.The device moves as the result of connectingstraps/cables or other mechanism powered by themovement of body segments, or it moves as theresult of a connection with another functionallimb component. The position of the device canbe maintained by a locking mechanism that isbody-powered. The device is used as part of anupper limb prosthetic system. This is a non-activemedical device.

172. Prosthetic socket, non-active

A device that fits over the terminal end of aresidual limb (stump) and serves as an interfacebetween the limb and prosthesis. This is a non-active medical device.

173. Patient restraint A non-rigid device, typically a strap or bandmade of various materials (e.g. fabric, nylon,leather, foam), used to temporarily secure thearm or leg of an adult patient to prevent injuryor hazards. The device is typically wrappedaround the patient’s arms or feet and anchoredto a fixture or furniture part (e.g. a bedrail),restricting movement of the patient andpreventing the patient from interfering withtreatment (e.g. removing an intravenous orurinary catheter, handling a dressed wound).

174. Restraint, fingers A device designed to restrict finger mobility andprevent potential injury.

31 S 140/2012




175. Restraint, body A device designed to secure a patient’s arms tothe torso to prevent self-inflicted injury.

176. Retainer, bandage A device used to stabilise, attach or fix abandage/dressing in a desired location. Thisdevice can be a fastener/clasp (e.g. an elasticstrip with opposing gripping teeth/hooks) ortubular elastic net. It is typically used on patientssensitive or allergic to adhesive tape.

177. Self-exam pad, breast A device for use as an aid in performing breastself-examination. It consists of 2 plastic sheetswith liquid sealed in between and is to be placedonto the breast. It reduces friction between thefingers and breast.

178. Shield, eye A mechanical shield, usually plastic or metallic,used for protection of one or both eyes followingsurgery or trauma.

179. Shield, face A clear, transparent guard worn over the face/eyes to protect the healthcare worker from bloodand other body fluid splashes while performing aclinical procedure.

180. Shield, hip A mechanical guard worn over the hip area toprevent against hip fractures in the event of apatient fall.

181. Shield, wound A mechanical shield that is designed to form aprotective structure over a wound. It may becage-like and will allow exposure to air andpermit access to the injured area while protectingagainst accidental damage.

32S 140/2012




182. Shield, radiation, apron A full-length or half-length apron-like garmentintended to shield portions of the body of apatient from exposure to radiation duringmedical or dental procedures. Some includeattached or detachable collars for neck andthyroid protection. The device typically consistsof a fluid-resistant outer covering surrounding athin sheet of lead or lead equivalent material.Those used for neutron attenuation arecomposed of hydrogenous materials; those usedin mixed beta-gamma radiation field may havelayers of both hydrogenous and lead equivalentmaterials.

183. Shield, radiation, bib A personal protective device intended to shieldthe chest area of a patient from unnecessaryexposure to radiation from diagnostic ortherapeutic medical and dental procedures. Somehave either attached or detachable collars usedfor neck and thyroid protection. Bibs used indiagnostic X-ray and nuclear medicine typicallyconsist of a fluid-resistant outer covering thatsurrounds a thin sheet of lead or lead equivalentmaterial. Bibs used for neutron attenuation arecomposed of hydrogenous materials; those usedin mixed beta-gamma radiation field may havelayers of both hydrogenous and lead equivalentmaterials.

184. Shield, radiation, blanket A personal protective device intended to shieldthe selected body parts of a patient, or others,from unnecessary exposure to radiation duringdiagnostic or therapeutic medical or dentalprocedures. Radiation protection blankets usedin diagnostic X-ray and nuclear medicinetypically consist of a fluid-resistant outercovering that surrounds a thin sheet of lead orlead equivalent material. Blankets intended toattenuate neutrons are composed of hydrogenousmaterials instead of lead. Blankets used in mixedbeta-gamma radiation field may have layers ofboth hydrogenous and lead equivalent materials.

33 S 140/2012




185. Shield, radiation, eye A personal protective device used to cover thepatient’s eyes and shield them from unnecessaryexposure to primary and scattered radiationassociated with diagnostic and therapeuticmedical procedures. Eye shields can come invarious shapes and are typically made of leadglass, lead or tungsten when attenuating photons,or hydrogenous materials when attenuatingneutrons.

186. Shield, radiation, thyroid A radiation protection device specificallydesigned to shield the thyroid of a patient fromunnecessary exposure to radiation fromdiagnostic medical and dental procedures. Thethyroid shield provides an attenuating barrierbetween the individual’s thyroid and the sourceof primary or scattered radiation. Structuralthyroid shields may be attached to the wall,ceiling or radiation delivery device by anarticulating arm that can be adjusted to shieldthe thyroid area of the throat. Others may bemore flexible and fit over the patient’s thyroid. Ittypically consists of a fluid-resistant outercovering that surrounds a thin sheet of leadmaterial.

187. Shield, shower A device designed to form a protective structureto cover part of the body in order to protectthese while the user is taking a bath or shower.The device is made of waterproof materials.

188. Anti-slip shoe, slipper,boot

A device designed to be worn or applied to theouter sole of the shoes of an elderly person or aperson with a disability to provide such personwith greater grip on the surface upon which he iswalking. It is typically used to assist mobility andhelp prevent slipping. This includes any anti-slipdevices attached to the shoe, such as clips, bandsor springs, that are used to help prevent slipping.

189. Orthotic shoe Orthopaedic footwear that is intended tosupport, align, or prevent or correct deformitiesof, the feet to help improve their function.

34S 140/2012




190. Cast boot A boot-like cover for a foot enclosed in a legcast. This device is generally equipped with awaterproof covering, an outer sole for walking,and closures for easy application and removal.

191. Shoe, cast A shoe designed to be worn over a foot/anklethat is encased in a cast, in order to protect thecast material and provide support.

192. Sling A hanging bandage or other material that isusually suspended from the body or anotherstructure, and used to support and limit therange of motion of an injured limb during thehealing period, or to support and limit the rangeof motion of a body in transport.

193. Spectacles An optical/ophthalmic device consisting of aspectacle frame that contains a pair of spectaclelenses (eyeglasses).

194. Splint A rigid or semi-rigid device that serves toimmobilise an injured limb or body part. It isgenerally placed externally along the injured limbor body part. It is typically made of plastic,mouldable plastic, wood or metal.

195. Splint, nasal, external A rigid or partially rigid device intended for useexternally for the immobilisation of parts of thenose typically after a fracture or treatment. Itmay function as a truss-like support on theoutside of the nose.

196. Stethoscope, mechanical A mechanical listening device used for listeningto sounds from the heart and lungs. It typicallycomprises a membrane at the listening headconnected by a split ‘‘Y’’ tube to the headgearwith ear olives that are placed into the user’sears. Mechanical stethoscopes are typically foundin 2 variants:

(a) a general-purpose stethoscope used forclinical/ward activities; or

(b) a reinforced stethoscope used bycardiologists.

35 S 140/2012




197. Cast stockinette A knitted, seamless tube of material, typicallycotton, designed to stretch and fit any contour ofthe body. The device is typically used as paddingunder a cast or splint.

198. Stocking, stockinette A knitted, seamless tubing, typically of cotton,that is open at both ends. The device is typicallyused to hold bandages in place, to place uniformpressure on a leg, finger, arm or other part of anextremity, to pad the area under a cast or splint,or to cover a stump when a prosthesis is worn.

199. Stocking, medicalsupport

An elastic limb support shaped as a stocking thatis worn on the upper or lower extremity tosupport, correct or prevent deformity, or to alignbody structures for functional improvement.

200. Stretcher A device on which a patient lies for transport orreclines after treatment. It may have a wheeledundercarriage, which can be foldable.

201. Stretcher, ambulance A stretcher specially adapted for use with anambulance vehicle, including aeroplanes,helicopters or boats. It will typically have anundercarriage which folds automatically when itmeets the ambulance vehicle as it is beingpushed in, as well as locking devices that matchup with the docking devices of the ambulancevehicle.

202. Stretcher, portable A device designed for transporting the patientfrom an emergency site, which is not readilyaccessible for standard ambulance stretchers. Itcan be used in mountain or marine rescue, ordifficult indoor situations (e.g. narrow corridorsor extremely steep stairways). It is designed tobe lightweight, simple in operation and easilytransported (e.g. ideally by one or 2 persons).The patient is often strapped to the device tokeep him secure during transportation.

36S 140/2012




203. Stretcher, bathroom A stretcher specially designed for the purpose ofwashing a patient whilst the patient lies on thestretcher. It will typically be used for patientswho are disabled or incapable of supportingthemselves and it may be submersed in anappropriate bath.

204. Reusable surgicalinstrument

An instrument intended for surgical use bycutting, drilling, sawing, scratching, scraping,clamping, retracting, clipping or other surgicalprocedures, without connection to any activemedical device and which is intended by theproduct owner to be reused after appropriateprocedures for cleaning and/or sterilisation havebeen carried out.

205. Swab A piece of absorbent material (e.g. cotton orfoam) attached to the end of a stick made ofwood, plastic or wire. It is used for theapplication of medication or the removal ofmaterial (save for the purpose of samplecollection). This is a single-use device.

206. Table, examination/treatment

A table or bed for examination and/or treatmentpurposes. It is typically of the construction wherethe patient lies upon it, i.e. as an operating table,but some may be designed so that the patient sitsbeside the table and is examined withinstruments placed upon the table. This devicecan be manually operated or powered. It may befitted with some basic functions (e.g. raise, loweror tilt) and is used in examination rooms,doctors’ surgeries and minor operating rooms.

207. Table, instrument A table used for laying out sterile surgicalinstruments, sutures, and other utensils/itemsrequired during an operation or intervention. Itis designed to include an appropriate (e.g.stainless steel) top or surface with no crevices,screws or rivets and may include telescopingpedestals for height adjustment and swivel castorbases. This table is used in the so-called ‘‘sterilearea’’ of the operation site and in some casesmay be attached to the operating table.

37 S 140/2012




208. Table, operation A device used to support the patient’s bodyduring surgical procedures, stabilising thepatient’s position and providing for optimalexposure of the surgical field. It is also designedto protect the patient from excessivemanipulation, trauma and abrasion. It willtypically include an appropriate top surfacesupported by a fixed pedestal or a movable,swivel castor base and may be divided into 3 ormore hinged sections (e.g. head, body and legs)which are raised and lowered by mechanical,electro-mechanical or hydraulic systems usingmanual or electric controls.

209. Table, birthing An adjustable table designed to support awoman’s body in an appropriate position duringlabour and delivery and in other examination/treatment procedures related to pregnancy. Thistable will typically include leg holders, tractionhandles, and a receptacle for afterbirth.

210. Tourniquet strap A device that is a strip of material of uniformbreadth which is applied to a limb in order tocompress the arteries and regulate the bloodflow. This is typically used when taking bloodsamples, but may be used for other purposes. Ithas a fastening mechanism (e.g. Velcro or a self-locking buckle) used for adjustment.

211. Traction unit, non-active A device used to apply a tensile force in order tocreate a distraction on body parts by means ofharnesses attached to the head or pelvic area. Itis non-active (static) in operation. It consists of arigid frame with non-powered tractionaccessories, such as cords, pulleys or weights, andis intended to apply a therapeutic pulling force tothe skeletal system.

212. Traction unit, non-invasive component

A non-invasive traction device (e.g. a headhalter, pelvic belt or a traction splint) that doesnot penetrate the skin and is intended to assist inconnecting a patient to a traction apparatus sothat a therapeutic pulling force may be appliedto the patient’s body.

38S 140/2012




213. Transfer aid, person A technical aid used by attending personnel toassist in the physical transfer of a person/patient(e.g. ill, disabled or infirm) from one position toanother. The device has typically no liftingcapabilities and uses sliding/turning techniques.This device may be used to change the person’sposition, especially for those incapable ofachieving this on their own, and thus preventbedsores, or to move the person between, forexample, an operating table and a bed, awheelchair and a bath, or a chair and the toilet.

214. Transfer belt A hand-held device used by attending personnelto lift a person/patient (e.g. up from the flooronto a bed). It may be used to provide additionalleverage while assisting patients in walking or inshort-distance transfer activities. The device canbe constructed like a carrying chair, harness,basket or lifting canvas and usually requiresmore than one person to operate it, therebyalleviating unnecessary strain upon each person’sback.

215. View box, bloodgrouping

A device with a glass or plastic viewing surface,which may be illuminated and heated, that isused to view cell reactions in antigen-antibodytesting.

216. View box, diagnosticimaging, non-motorised

A non-motorised device used to support andilluminate one or more medical images (e.g.X-ray, magnetic resonance imaging (MRI),computed tomography (CT), ultrasound ornuclear medicine) which are recorded onradiographic film (e.g. an X-ray or X-ray film)for direct viewing. This kind of radiographic viewbox is a simple non-motorised wall-mounted ortable-mounted design. The device has a definedillumination uniformity and an attachment that isused to hold as many sheets of film in place asthere is room for during viewing.

39 S 140/2012




217. Walking crutch A mobility aid used to assist a disabled or aninfirm user in walking by providing a means ofsupport and increasing his ability to move aroundwithout attendance from another person. It hasone leg, a handle, and a padded platform whichis placed under the armpit or forearm forsupport.

218. Walking frame, standard,non-active

A mobility aid used to assist a disabled or aninfirm user in walking by providing a means ofsupport and increasing his ability to move aroundwithout attendance from another person. It isa non-wheeled frame with built-in handgrips andlegs which provide support whilst walking. Itcan be of fixed or adjustable height and becollapsible or non-collapsible. This is a non-active medical device.

219. Walking table, non-active A mobility aid used to assist a disabled or aninfirm user in walking by providing a means ofsupport and increasing his ability to move aroundwithout attendance from another person. It isa chest-height wheeled frame with a horizontalforearm support, which is pushed along using thearms and/or upper body. It can be of fixed oradjustable height and be collapsible or non-collapsible. This is a non-active medical device.

220. Walking frame, wheeled,non-active

A mobility aid used to assist a disabled or aninfirm user in walking by providing a means ofsupport and increasing his ability to move aroundwithout attendance from another person. It is awheeled frame with built-in handgrips and legswhich provide support whilst walking. It can beof fixed or adjustable height and be collapsibleor non-collapsible. This is a non-active medicaldevice.

40S 140/2012




221. Walking stick A mobility aid used to assist a disabled or aninfirm user in walking by providing a means ofsupport and increasing his ability to move aroundwithout attendance from another person. It isa wooden or metal rod with either one leg,a tripod or quadripod base (3 or 4 legs). It hasa handle and/or forearm support. It can be offixed or adjustable length and be collapsible ornon-collapsible.

222. Wrapper, sterilisation A device intended to enclose medical devicesthat are to be sterilised. It is designed to allowsterilisation of the enclosed medical device andalso to maintain sterility of the device until thepackaging is opened for use of the device, oruntil a predetermined shelf date is expired.

223. X-ray film A film specifically designed for medical or dentaldiagnostic imaging using X-ray. It is prepared asan emulsion of light and X-ray sensitive granuleson one (single-emulsion film) or both (double-emulsion film) sides of a transparent film basemade of cellulose acetate, polyester resin orother appropriate material. It can basically beseparated into 2 major kinds: screen and non-screen film. Screen film is sensitive primarily tothe wavelengths of light emitted from image-intensifying screens. Non-screen film is designedfor direct exposure to X-rays and is relativelyinsensitive to the visible light emitted fromscreens. Screen film is not limited to use withX-ray imaging systems. ’’.

[G.N. No. S 542/2011]

Made this 4th day of April 2012.SERENE WEE

Acting Chairman,Health Sciences Authority,

Singapore.

[HSA (HPRG) 401:04/01-000; AG/LLRD/SL/122D/2010/9 Vol. 1]

(To be presented to Parliament under section 72(5) of the HealthProducts Act).

41 S 140/2012

Health Products (Medical Devices)(Amendment) Regulations 2012

Documents

Transcript of Health Products (Medical Devices)(Amendment) Regulations 2012