Scope of Accreditation of Testing Laboratory (EN ISO/IEC 17025:2005) HygCen Austria GmbH / (ID No.: 0196)
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3 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO Testing on the cleaning efficacy of chemo-thermal laundry disinfection procedures in laundries Hygienic examination of surrounding areas in reprocessing facilities for medical devices and similar 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 Testing of the cleaning efficacy of washer disinfectors for thermolabile endoscopes in accordance with the guideline of ÖGSV Quantitative determination of free NH2 groups of bloodproteins by the modified OPA method 6 DGHM Chapter 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 Ventilation and air conditioning Part 4: Ventilation in buildings and rooms of health care 8 DIN 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) 61 test methods VNo 6316 Page 1 of 10
4 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 9 DIN German standard methods for the of water, waste water and sludge; Microbiological methods (group K); Detection of Pseudomonas aeruginosa (K8) 10 EN Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics Test method and requirements (phase 11 EN Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics Test method and requirements (phase 12 EN 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 13 EN Chemical disinfectants and antiseptics Surgical hand disinfection Test method and requirements (phase 2/step 14 EN Workplace atmosphere - Guidelines for measurement of airborne microorganisms and endotoxin 61 test methods VNo 6316 Page 2 of 10
5 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 15 EN Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems Test method and requirements (phase 2, step 16 EN Chemical disinfectants and antiseptics Quantitative 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 17 EN Chemical disinfectants and antiseptics Quantitative 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 18 EN 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 61 test methods VNo 6316 Page 3 of 10
6 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 19 EN A Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity in the medical area Test method and requirements (phase 2, step 20 EN Chemical disinfectants and antiseptics Quantitative 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 21 EN Chemical disinfectants and antiseptics Basic sporicidal activity Test method and requirements (phase 22 EN Chemical disinfectants and antiseptics Quantitative 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 23 EN Chemical disinfectants and antiseptics Quantitative 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 61 test methods VNo 6316 Page 4 of 10
7 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 24 EN Chemical disinfectants and antiseptics Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area Test method and requirements (phase 2, step 25 EN Chemical disinfectants and antiseptics Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area Test method and requirements (phase 2, step 26 EN Chemical disinfectants and antiseptics Quantitative 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 27 EN Chemical disinfectants and antiseptics Hygienic handwash Test method and requirements (phase 2/step 28 EN Chemical disinfectants and antiseptics - Hygienic handrub Test method and requirements (phase 2/ step 29 EN 1650+A 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 61 test methods VNo 6316 Page 5 of 10
8 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 30 EN 1656/AC 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 31 EN 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 32 EN Chemical disinfectants and antiseptics - Chemicalthermal textile disinfection - Test method and requirements (phase 2, step 33 EN Water quality Detection and enumeration of the not for the of drinking water according to TWspores of sulfite-reducing anaerobes (clostridia); part 2: VO method by membrane filtration (ISO :1986) 34 EN Water quality; determination of electrical conductivity (ISO 7888:1985) 35 EN ISO Water quality - Determination of ph (ISO 10523:2008) 36 EN ISO /AC Sterilization of medical devices Microbiological methods - Part 1: Determination of a population of micro-organisms on products (ISO :2006) 61 test methods VNo 6316 Page 6 of 10
9 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 37 EN ISO Sterilization of medical devices Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of the sterilization process (ISO :2009) 38 EN ISO Water quality Detection and enumeration of Pseudomonas aeruginosa by membrane filtration (ISO 16266:2006) 39 EN ISO Water quality Sampling for microbiological (ISO 19458:2006) 40 EN ISO Textiles - Determination of the antibacterial activity of textile products (ISO 20743:2013) 41 EN ISO Water quality - Enumeration of culturable microorganisms - Colony count by inoculation in a nutrient agar culture medium (ISO 6222:1999) 42 EN ISO Water quality - Determination of the free chlorine and total chlorine Part 2: Colorimetric method using N,Ndiethyl-1,4-phenylendiamine for routine control purpose (ISO :1985) 43 EN ISO Water quality Detection and enumeration of intestinal enterococci - Part 2: Membrane filtration method (ISO :2000) 44 EN ISO Water quality - Enumeration of Escherichia coli and coliform bacteria - Part 1: Membrane filtration method for waters with low bacterial background flora (ISO :2014) 61 test methods VNo 6316 Page 7 of 10
10 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 45 Eur.Ph Testing for microbial contamination in sterile products: enumeration of total, viable, aerobe and anaerobe microorganisms 46 ISO Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts 47 ISO Water quality Sampling - Part 4: Guidance on sampling from lakes, natural and man-made 48 ISO Water quality Sampling - Part 5: Guidance on sampling of drinking water from treatment works and piped distribution systems 49 ISO/TS Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy 50 JIS L Testing for antibacterial activity and efficacy on textile products 51 JIS Z Antimicrobial products-test for antimicrobial activity and efficacy Chapter 3 Chapter 5 61 test methods VNo 6316 Page 8 of 10
11 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 52 OENORM M Bathing waters - Requirements for water quality, and assessment 53 OENORM M Water - Determination of temperature Limited on the sampling 54 OENORM M Water Methods and result information to the description of the external quality of a water test 55 pren 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 56 VAH method Requirements and methods to the VAH- certified chemical disinfection methods: surface disinfection without mechanics practical test (method 14) 57 VAH method Requirements and methods to the VAH- certified chemical disinfection methods: chemical/ chemothermal disinfection of instruments - practical quantitative germ carrier test (method 15) 58 VAH method Requirements and methods to the VAH- certified chemical disinfection methods: chemo- thermal laundry disinfection single bath method (practical test) (method 17) 61 test methods VNo 6316 Page 9 of 10
12 HygCen Austria GmbH / (ID : 0196) issue title remarks PvO 59 VAH method 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 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 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 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. PvO: test can - if selected - also be done locally. 61 test methods VNo 6316 Page 10 of 10
13 Supplement to notification GZ.: BMWFW /0417-I/12/2016 HygCen_17020 Scope of Accreditation of inspection body (EN ISO/IEC 17020:201 HygCen Austria GmbH / (ID : 0196) date of product / category issue title (remarks) 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 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, Hygienic assessment of IVF institutes Site inspection, documentation review, environmental investigation Hygienic examination of reprocessing of dishwashers documentation review, testing of cleaning and disinfection, impression investigation, program parameters conformity assessment procedures / module 28 inspection methods VNo 6317 Page 1 of 7
14 Supplement to notification GZ.: BMWFW /0417-I/12/2016 HygCen_17020 Scope of Accreditation of inspection body (EN ISO/IEC 17020:201 HygCen Austria GmbH / (ID : 0196) 5 AK KAB- Arbeitskreis Käfigaufbereitung date of issue title product / category (remarks) Cage processing in animal facilities (5th Edition) documentation review, program parameters, testing of cleaning and disinfection, water 6 BGBl. 04/ Hygiene requirements to the structural and functional design and apparative equipment of endoscopy units, RKI 7 BGBl. II 262/ Regulation of the Minister of Economy and Labour on exercise rules for foot care, cosmetics and massage by professionals 8 BGBl. II 321/ 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 201 Site inspection, documentation review, Site inspection, documentation review, environmental investigation, determination of a population of microorganisms on products, sterility of products, biological indicators Pools acc. 42 and 43; warm bubble bath (whirlpools) acc. 57 and 58; excluding chemical parameters in the laboratory conformity assessment procedures / module Inspection acc. chapter 7 4, inspection activity to create an inspection report inspections (to be obtained water hygienic certificates, which the operator has to commission in accordance with 14( ff BHygG) 28 inspection methods VNo 6317 Page 2 of 7
15 Supplement to notification GZ.: BMWFW /0417-I/12/2016 HygCen_17020 Scope of Accreditation of inspection body (EN ISO/IEC 17020:201 HygCen Austria GmbH / (ID : 0196) date of issue title 9 BGesBl. 07/ Hygiene requirements to laundry and washing procedures and conditions for granting of laundry reprocessing to commercial laundries; RKI product / category (remarks) Site inspection, documentation review, environmental investigation, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection 10 EN Small steam sterilizers documentation review, biological indicators 11 EN Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing 12 EN Controlled environment storage cabinet for processed thermolabile endoscopes 13 EN Sterilization Steam sterilizers Large sterilizers 14 EN ISO 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, biological indicators, chemical indicators, desorption review documentation review, program parameters, testing of cleaning and disinfection, water documentation review, measurement of inert gas, water, biological indicators documentation review, biological indicators, chemical indicators, regulation for residual gas conformity assessment procedures / module 28 inspection methods VNo 6317 Page 3 of 7
16 Supplement to notification GZ.: BMWFW /0417-I/12/2016 HygCen_17020 Scope of Accreditation of inspection body (EN ISO/IEC 17020:201 HygCen Austria GmbH / (ID : 0196) date of issue title 15 EN ISO 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) 16 EN ISO /A Washer-disinfectors - Part 1: General requirements, definitions and tests (ISO : Amd 1:2014) 17 EN ISO 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 :2006) 18 EN ISO Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO :2006) 19 EN ISO Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermo-labile endoscopes (ISO :2008) product / category (remarks) among others for hydrogenperoxide / plasma-method in use; Documentation review, biological indicators, chemical indicators, microbiological Documentation review, program parameters, inspection of cleaning and disinfection, water documentation review, program parameters, testing of cleaning and disinfection, water documentation review, program parameters, testing of cleaning and disinfection, water documentation review, program parameters, testing of cleaning and disinfection, water conformity assessment procedures / module 28 inspection methods VNo 6317 Page 4 of 7
17 Supplement to notification GZ.: BMWFW /0417-I/12/2016 HygCen_17020 Scope of Accreditation of inspection body (EN ISO/IEC 17020:201 HygCen Austria GmbH / (ID : 0196) date of issue title 20 EN ISO Washer-disinfectors Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO :201; 21 EN ISO 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 :2016) 22 EN ISO Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) 23 EN ISO 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 :2006) product / category (remarks) Documentation review, program parameters, testing of cleaning and disinfection, water Documentation review, program parameters, testing of cleaning and disinfection, water Documentation review, inspection of cleaning and disinfection, sterilisation and drying Documentation review, water conformity assessment procedures / module 28 inspection methods VNo 6317 Page 5 of 7
18 Supplement to notification GZ.: BMWFW /0417-I/12/2016 HygCen_17020 Scope of Accreditation of inspection body (EN ISO/IEC 17020:201 HygCen Austria GmbH / (ID : 0196) 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) date of issue title Requirements to hygiene in the reprocessing of medical devices 25 OENORM B Hygienic aspects of the planning, construction, operation, maintenance, surveillance and rehabilitation of central heating installations for drinking water 26 OENORM H Ventilation and air condition plants for locations for medical use Design, construction, operation, maintenance, technical and hygienic inspections product / category (remarks) 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, program parameters, sterility testing of operation materials used as medical devices for patients, clinic staff and devices, Site inspection, documentation review, sampling, water 5.2 and H , table 1 Site inspection, documentation review, particle measurement, airborne germs measurement, impression investigation, microbiological of liquid mediums conformity assessment procedures / module Inspection acc. chapter 6 Inspection acc. chapter 5.2 and OENORM H , table 1 28 inspection methods VNo 6317 Page 6 of 7
19 Supplement to notification GZ.: BMWFW /0417-I/12/2016 HygCen_17020 Scope of Accreditation of inspection body (EN ISO/IEC 17020:201 HygCen Austria GmbH / (ID : 0196) date of issue title 27 OENORM M Water intended for human consumption Instructions for the activity of inspection bodies 28 VDI 6022 Blatt Ventilation and indoor-air quality - Hygiene requirements for ventilation and air-conditioning systems and units (VDI Ventilation Code of Practice) product / category (remarks) Site inspection, documentation review, particle measurement, airborne germs measurement, impression investigation, microbiological of liquid mediums conformity assessment procedures / module Inspection acc. to part 5.3; 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. 28 inspection methods VNo 6317 Page 7 of 7
inspection body type A
inspection body type A legal entity HygCen Austria GmbH Werksgelände 28, 5500 Bischofshofen web www.hygcen.at ident no. 0196 site HygCen Austria GmbH Werksgelände 28, 5500 Bischofshofen initial date of
ASTM Workshop on Medical Device Cleanliness
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