Supplement to notification.: BMWFW-92.221/0740 … · handrub – Test method and requirements...

Supplement to notification.: BMWFW-92.221/0740-I/12/2016 HygCen_17025T

Scope of Accreditation of Testing Laboratory (EN ISO/IEC 17025:2005)

HygCen Austria GmbH / (ID No.: 0196)

61 test methods VNo 6316 Page 1 of 10

valid from: 2016-09-20

No. document number 1)

of the standard or SOP

issue

title of the standard or SOP

remarks PvO

2)

1 02-030 2008-05 Testing on the cleaning efficacy of chemo-thermal laundry disinfection procedures in laundries

2 11-001 2016-04 Hygienic examination of surrounding areas in

reprocessing facilities for medical devices and similar

3 16-009 2014-05 Testing of the cleaning efficacy of washer disinfectors

for thermostable & thermolabile medical devices in accordance with the guideline of ÖGSV respectively

DGKH, DGSV and AKI

4 16-010 2014-11 Testing of the cleaning efficacy of washer disinfectors for thermolabile endoscopes in accordance with the guideline of ÖGSV

5 17-008 2012-09 Quantitative determination of free NH2 groups of blood-proteins by the modified OPA method

6 DGHM Chapter 4 2001-09 Standard DGHM methods of testing chemical disinfectants - Chapter 4: Testing of the disinfecting efficacy of chemo-thermal laundry disinfection procedures in laundries (DGHM)

7 DIN 1946-4 2008-12 Ventilation and air conditioning – Part 4: Ventilation in

buildings and rooms of health care

8 DIN 38409-9 1980-07 German standard methods for the examination of water, waste water and sludge; general measures of effects and substances (group H), determination of the settleable matter by volume in water and waste water (H9)








issue


remarks PvO

2)

9 DIN 38411-8 1982-05 German standard methods for the analysis of water, waste water and sludge; Microbiological methods (group K); Detection of Pseudomonas aeruginosa (K8)

10 EN 1040 2005-12 Chemical disinfectants and antiseptics – Quantitative

suspension test for the evaluation of basic bactericidal

activity of chemical disinfectants and antiseptics – Test

method and requirements (phase 1)


suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics – Test method and requirements (phase 1)

12 EN 1276 2009-10 Chemical disinfectants and antiseptics –Quantitative

suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food,

industrial, domestic, and institutional areas – Test

method and requirements (phase 2, step 1)

13 EN 12791 2005-07 Chemical disinfectants and antiseptics – Surgical hand

disinfection – Test method and requirements

(phase 2/step 2)

14 EN 13098 2000-09 Workplace atmosphere - Guidelines for measurement of airborne microorganisms and endotoxin








issue


remarks PvO

2)


suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for

aqueous systems – Test method and requirements

(phase 2, step 1)


suspension test for the evaluation of fungicidal activity of chemical disinfection for instruments used in the

medical area – Test method and requirements (phase 2,

step 1)


non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and

institutional areas – Test method and requirements

without mechanical action (phase 2, step 2)

18 EN 13704 2002-02 Chemical disinfectants – Quantitative suspension test

for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas – Test method and requirements

(phase 2, step 1)








issue


remarks PvO

2)

19 EN 13727+A2 2015-10 Chemical disinfectants and antiseptics – Quantitative

suspension test for the evaluation of bactericidal activity

in the medical area – Test method and requirements

(phase 2, step 1)


suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area – Test method and requirements

(phase 2, step 1)

21 EN 14347 2005-03 Chemical disinfectants and antiseptics – Basic

sporicidal activity – Test method and requirements

(phase 1)


suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area

including instrument disinfectants – Test method and

requirements (phase 2, step 1)


surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without

mechanical action – Test method and requirements

(phase 2, step 2)








issue


remarks PvO

2)


carrier test for the evaluation of bactericidal activity for

instruments used in the medical area – Test method

and requirements (phase 2, step 2)


carrier test for the evaluation of fungicidal or yeasticidal

activity for instruments used in the medical area – Test

method and requirements (phase 2, step 2)


carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for

instruments in the medical area – Test method and

requirements (phase 2, step 2)

27 EN 1499 2013-04 Chemical disinfectants and antiseptics – Hygienic

handwash – Test method and requirements (phase

2/step 2)

28 EN 1500 2013-04 Chemical disinfectants and antiseptics - Hygienic handrub – Test method and requirements (phase 2/

step 2)

29 EN 1650+A1 2013-05 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and

institutional areas – Test method and requirements

(phase 2, step 1)








issue


remarks PvO

2)

30 EN 1656/AC 2010-08 Chemical disinfectants and antiseptics – Quantitative

suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the

veterinary area – Test method and requirements (phase

2, step 1)

31 EN 16615 2015-04 Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2)

32 EN 16616 2015-08 Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)

33 EN 26461-2 1993-01 Water quality – Detection and enumeration of the

spores of sulfite-reducing anaerobes (clostridia); part 2:

method by membrane filtration (ISO 6461-2:1986)

not for the analysis of drinking water according to TW-VO

34 EN 27888 1993-09 Water quality; determination of electrical conductivity (ISO 7888:1985)

35 EN ISO 10523 2012-02 Water quality - Determination of pH (ISO 10523:2008)

36 EN ISO 11737-1/AC 2009-04 Sterilization of medical devices – Microbiological

methods - Part 1: Determination of a population of micro-organisms on products (ISO 11737-1:2006)








issue


remarks PvO

2)

37 EN ISO 11737-2 2009-11 Sterilization of medical devices – Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of the sterilization process (ISO 11737-2:2009)

38 EN ISO 16266 2008-02 Water quality – Detection and enumeration of Pseudomonas aeruginosa by membrane filtration (ISO 16266:2006)

39 EN ISO 19458 2006-08 Water quality – Sampling for microbiological analysis (ISO 19458:2006)

40 EN ISO 20743 2013-07 Textiles - Determination of the antibacterial activity of textile products (ISO 20743:2013)

41 EN ISO 6222 1999-05 Water quality - Enumeration of culturable micro-organisms - Colony count by inoculation in a nutrient agar culture medium (ISO 6222:1999)

42 EN ISO 7393-2 2000-01 Water quality - Determination of the free chlorine and total chlorine – Part 2: Colorimetric method using N,N-diethyl-1,4-phenylendiamine for routine control purpose (ISO 7393-2:1985)

43 EN ISO 7899-2 2000-04 Water quality – Detection and enumeration of intestinal enterococci - Part 2: Membrane filtration method (ISO 7899-2:2000)

44 EN ISO 9308-1 2014-09 Water quality - Enumeration of Escherichia coli and coliform bacteria - Part 1: Membrane filtration method for waters with low bacterial background flora (ISO 9308-1:2014)








issue


remarks PvO

2)

45 Eur.Ph. 2.6.1 2012-01 Testing for microbial contamination in sterile products: enumeration of total, viable, aerobe and anaerobe microorganisms

46 ISO 11731-2 2004-05 Water quality – Detection and enumeration of

Legionella – Part 2: Direct membrane filtration method

for waters with low bacterial counts

47 ISO 5667-4 2016-06 Water quality — Sampling - Part 4: Guidance on

sampling from lakes, natural and man-made

48 ISO 5667-5 2006-04 Water quality — Sampling - Part 5: Guidance on

sampling of drinking water from treatment works and piped distribution systems

49 ISO/TS 15883-5 2005-11 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy

50 JIS L 1902 2008-10 Testing for antibacterial activity and efficacy on textile products

Chapter 3

51 JIS Z 2801 2012-05 Antimicrobial products-Test for antimicrobial activity and efficacy

Chapter 5








issue


remarks PvO

2)

52 OENORM M 6230 2015-06 Bathing waters - Requirements for water quality, analysis and assessment

Limited on the sampling

53 OENORM M 6616 1994-03 Water analysis - Determination of temperature

54 OENORM M 6620 2012-12 Water analysis – Methods and result information to the

description of the external quality of a water test

55 prEN 1657 2014-04 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)

56 VAH method 14 2015-04 Requirements and methods to the VAH- certified chemical disinfection methods: surface disinfection

without mechanics – practical test (method 14)

57 VAH method 15 2015-04 Requirements and methods to the VAH- certified chemical disinfection methods: chemical/ chemo- thermal disinfection of instruments - practical quantitative germ carrier test (method 15)

58 VAH method 17 2015-04 Requirements and methods to the VAH- certified chemical disinfection methods: chemo- thermal laundry

disinfection – single bath method (practical test)

(method 17)








issue


remarks PvO

2)

59 VAH method 7 2015-04 Requirements and methods to the VAH- certified chemical disinfection methods: determination of the bacteriostatic and levurostatic effectiveness as well as suitable neutralizer (method 7)

60 VAH method 8 2015-04 Requirements and methods to the VAH- certified chemical disinfection methods: determination of the bactericidal and yeastidical effectiveness in a qualitative suspension test

61 VAH method 9 2015-04 Requirements and methods to the VAH- certified chemical disinfection methods: determination of the bactericidal, yeastidical, fungicidal, tuberculocidal or mycobactericidal effectiveness in a quantitative suspension test

1) Any amendments of standards apply as with accredited, provided that there is no new conformity assessment procedures are defined. Austrian laws and regulations as well as EU regulations are accredited in the applicable version, unless otherwise indicated.

2) PvO: test can - if selected - also be done locally.

Supplement to notification GZ.: BMWFW-92.251/0417-I/12/2016 HygCen_17020

Scope of Accreditation of inspection body (EN ISO/IEC 17020:2012)


28 inspection methods VNo 6317 Page 1 of 7




date of issue

title of the standard or SOP product / category

(remarks)

conformity assessment procedures / module

1 21-010 2015-11 Hygiene Management System in laundries

Site inspection, documentation review, environmental investigation, air technology systems, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection

2 21-011 2014-04 Hygiene Management System - reprocessing of textile operating room materials - examination of processes and procedures

Site inspection, documentation review, environmental investigation, air technology systems, determination of a population of microorganisms on products, thermoelectric examination, examination of process- and program parameters, sterility testing of operation materials used as medical devices for patients, clinic staff and devices,

3 21-055 2014-05 Hygienic assessment of IVF institutes

Site inspection, documentation review, environmental investigation

4 21-070 2014-06 Hygienic examination of reprocessing of dishwashers

documentation review, testing of cleaning and disinfection, thermoelectric examination, impression investigation, examination of process- and program parameters








date of issue


(remarks)


5 AK KAB- Arbeitskreis

Käfigaufbereitung

2016-01 Cage processing in animal facilities (5th Edition) documentation review, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection, water analysis

Inspection acc. chapter 7

6 BGBl. 04/2002 2002-04 Hygiene requirements to the structural and functional design and apparative equipment of endoscopy units, RKI

Site inspection, documentation review,

7 BGBl. II No. 262/2008 2008-07 Regulation of the Minister of Economy and Labour on exercise rules for foot care, cosmetics and massage by professionals

Site inspection, documentation review, environmental investigation, determination of a population of microorganisms on products, sterility of products, thermoelectric examination, biological indicators

§4, inspection activity to create

an inspection report

8 BGBl. II No. 321/2012 2012-09 Regulation of the Minister of Health on hygiene in bathrooms, hot tub pools, (whirlpools), saunas, hot air and steam baths as well as small swimming ponds (Pool hygiene regulation 2012 – BhygV 2012)

Pools acc. § § 42 and 43; warm bubble bath (whirlpools) acc. §§ 57 and 58; excluding chemical parameters in the laboratory

inspections (to be obtained water hygienic certificates, which the operator has to commission in

accordance with § 14(2) ff

BHygG)








date of issue


(remarks)


9 BGesBl. 07/1995 1995-07 Hygiene requirements to laundry and washing procedures and conditions for granting of laundry reprocessing to commercial laundries; RKI

Site inspection, documentation review, environmental investigation, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection

10 EN 13060 2014-12 Small steam sterilizers documentation review, thermoelectric examination, biological indicators

11 EN 14180 2014-05 Sterilizers for medical purposes – Low

temperature steam and formaldehyde sterilizers

– Requirements and testing

documentation review, thermoelectric examination, biological indicators, chemical indicators, desorption review

12 EN 16442 2015-03 Controlled environment storage cabinet for processed thermolabile endoscopes

documentation review, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection, water analysis

13 EN 285 2015-12 Sterilization – Steam sterilizers – Large

sterilizers

documentation review, thermoelectric examination, measurement of inert gas, water analysis, biological indicators

14 EN ISO 11135 2014-07 Sterilization of health care products – Ethylene

oxide – Requirements for the development,

validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

documentation review, thermoelectric examination, biological indicators, chemical indicators, regulation for residual gas








date of issue


(remarks)


15 EN ISO 14937 2009-10 Sterilization of health care products – General

requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

among others for hydrogen-peroxide / plasma-method in use; Documentation review, thermoelectric examination, biological indicators, chemical indicators, microbiological analysis

16 EN ISO 15883-1/A1 2014-07 Washer-disinfectors - Part 1: General requirements, definitions and tests

(ISO 15883-1:2006 + Amd 1:2014)

Documentation review, thermoelectric examination, examination of process- and program parameters, inspection of cleaning and disinfection, water analysis

17 EN ISO 15883-2 2009-06 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)


18 EN ISO 15883-3 2009-06 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO15883-3:2006)


19 EN ISO 15883-4 2009-06 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermo-labile endoscopes

(ISO 15883-4:2008)









date of issue


(remarks)


20 EN ISO 15883-6 2015-08 Washer-disinfectors – Part 6: Requirements and

tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

(ISO 15883-6:2011);

Documentation review, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection, water analysis

21 EN ISO 15883-7 2016-03 Washer-disinfectors – Part 7: Requirements and

tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)

Documentation review, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection, water analysis

22 EN ISO 17664 2004-03 Sterilization of medical devices – Information to

be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

Documentation review, inspection of cleaning and disinfection, sterilisation and drying

23 EN ISO 17665-1 2006-08 Sterilization of health care products – Moist heat

– Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices

(ISO 17665-1:2006)

Documentation review, thermoelectric examination, water analysis








date of issue


(remarks)


24 KRINKO/BfArM - Richtlinie: Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch- Institut (RKI) und des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM)

2012-10 Requirements to hygiene in the reprocessing of medical devices

Only the parts concerning the reprocessing of medical devices; Site inspection, documentation review, environmental investigation, air technical systems, determination of a population of microorganisms on products, sterility of products, thermoelectric examination, examination of process- and program parameters, sterility testing of operation materials used as medical devices for patients, clinic staff and devices,

25 OENORM B 5019 2011-05 Hygienic aspects of the planning, construction, operation, maintenance, surveillance and rehabilitation of central heating installations for drinking water

Site inspection, documentation review, sampling, water analysis

Inspection acc. chapter 6

26 OENORM H 6020 2015-03 Ventilation and air condition plants for locations

for medical use – Design, construction,

operation, maintenance, technical and hygienic inspections

5.2 and H 6020-2, table 1

Site inspection, documentation review, particle measurement, airborne germs measurement, impression investigation, microbiological analysis of liquid mediums

Inspection acc. chapter 5.2 and OENORM H 6020-2, table 1








date of issue


(remarks)


27 OENORM M 5874 2009-07 Water intended for human consumption –

Instructions for the activity of inspection bodies

28 VDI 6022 Blatt 1 2011-07 Ventilation and indoor-air quality - Hygiene requirements for ventilation and air-conditioning systems and units (VDI Ventilation Code of Practice)

Site inspection, documentation review, particle measurement, airborne germs measurement, impression investigation, microbiological analysis of liquid mediums

Inspection acc. to part 5.3;

1) Any amendments of standards apply as with accredited, provided that there is no new conformity assessment procedures are defined. Austrian laws and regulations as well as EU regulations are accredited in the applicable version, unless otherwise indicate.

Supplement to notification.: BMWFW-92.221/0740 … · handrub – Test method and requirements...

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