{"standard":"EN ISO 11137-1","listings":[{"edition":"EN ISO 11137-1:2015","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"},{"edition":"EN ISO 11137-1:2015","list":"mdr","list_name":"Medical Devices Regulation","jurisdiction":"EU","title":"Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617"},{"edition":"EN ISO 11137-1:2015","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"30/09/2021","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"},{"edition":"EN ISO 11137-1:2015","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"},{"edition":"EN ISO 11137-1:2015","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)","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 11137-1:2015","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-medical-devices"}],"events":[],"generated":"2026-08-17 02:41 UTC"}