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2 inspection body type A legal entity HygCen Austria GmbH Werksgelände 28, 5500 Bischofshofen web ident no site HygCen Austria GmbH Werksgelände 28, 5500 Bischofshofen initial date of accreditation level 3 accreditation standard EN ISO/IEC 17020:2012 according EA-1/06 According to 7 AkkG 2012, the harmonized Level 3 accreditation standard on which the accreditation is based and as well as the applicable instruction documents/guides or obligatory declared normative documents from EA - European co-operation for Accreditation, the ILAC - International Laboratory Accreditation Cooperation and the Accreditation Austria in the valid version must be observed and complied with. Accreditation is additionally granted in accordance with the following provisions, which must also be observed in the currently valid version. other requirements EA-3/01:2013 ILAC-P15: inspection methods VNo 6720 Page 1 of 8
3 date of of the standard or SOP issue title of the standard or SOP Hygiene Management System in laundries 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 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 investigation Hygienic examination of reprocessing of dishwashers testing of cleaning and disinfection, impression investigation, program parameters 26 inspection methods VNo 6720 Page 2 of 8
4 of the standard or SOP date of issue title of the standard or SOP Validation of manual cleaning and manual chemical disinfection of medical devices (Guideline 2013) 6 AK KAB- Arbeitskreis Käfigaufbereitung testing of cleaning and disinfection program parameters Cage processing in animal facilities (5th Edition) 7 BGBl. 04/ Hygiene requirements to the structural and functional design and apparative equipment of endoscopy units, RKI 8 BGBl. II 262/ Regulation of the Minister of Economy and Labour on exercise rules for foot care, cosmetics and massage by professionals 9 BGesBl. 07/ Hygiene requirements to laundry and washing procedures and conditions for granting of laundry reprocessing to commercial laundries; RKI review, investigation, determination of a population of microorganisms on products, sterility of products, biological indicators investigation, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection Inspection acc. chapter 7 4, inspection activity to create an inspection report 26 inspection methods VNo 6720 Page 3 of 8
5 of the standard or SOP date of issue title of the standard or SOP 10 EN Small steam sterilizers 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) biological indicators, chemical indicators, desorption review measurement of inert gas, water, biological indicators biological indicators, chemical indicators, regulation for residual gas 26 inspection methods VNo 6720 Page 4 of 8
6 date of of the standard or SOP issue title of the standard or SOP 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) among others for hydrogenperoxide / plasma-method in use; Documentation review, biological indicators, chemical indicators, microbiological program parameters, inspection of 26 inspection methods VNo 6720 Page 5 of 8
7 date of of the standard or SOP issue title of the standard or SOP 19 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; 20 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) 21 EN ISO Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) 22 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) testing of cleaning, disinfection, sterilisation and drying water 26 inspection methods VNo 6720 Page 6 of 8
8 of the standard or SOP 23 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 of the standard or SOP Requirements to hygiene in the reprocessing of medical devices 24 OENORM H Ventilation and air condition plants for locations for medical use Design, construction, operation, maintenance, technical and hygienic inspections 25 pren ISO Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermo-labile endoscopes (ISO/DIS :2016) Only the parts concerning the reprocessing of medical devices; 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 5.2 and H , table 1 review, particle measurement, airborne germs measurement, impression investigation, microbiological of liquid mediums Inspection acc. chapter 5.2 and OENORM H , table 1 26 inspection methods VNo 6720 Page 7 of 8
9 of the standard or SOP date of issue title of the standard or SOP 26 VDI 6022 Blatt Ventilation and indoor-air quality - Hygiene requirements for ventilation and air-conditioning systems and units (VDI Ventilation Code of Practice) review, particle measurement, airborne germs measurement, impression investigation, microbiological of liquid mediums Inspection acc. to part 5.3; Any amendments of standards apply as with accredited, provided that there is no new procedures are defined. Austrian laws and regulations as well as EU regulations are accredited in the applicable version, unless otherwise indicate. 26 inspection methods VNo 6720 Page 8 of 8
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