{"standard":"EN ISO 11737-2","listings":[{"edition":"EN ISO 11737-2:2009","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"17/01/2026","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"},{"edition":"EN ISO 11737-2:2009","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-medical-devices"},{"edition":"EN ISO 11737-2:2020","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"},{"edition":"EN ISO 11737-2:2020","list":"mdr","list_name":"Medical Devices Regulation","jurisdiction":"EU","title":"Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617"},{"edition":"EN ISO 11737-2:2020","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process","annex":"S.I. 2002/618","pc_start":"17/01/2026","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"},{"edition":"EN ISO 11737-2:2020","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process","annex":"S.I. 2002/618","pc_start":"17/01/2026","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-medical-devices"}],"events":[],"generated":"2026-08-17 02:41 UTC"}