{"standard":"EN 556-1","listings":[{"edition":"EN 556-1:2001","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices","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 556-1:2001","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices","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 556-1:2024","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 1: Requirements for terminally sterilized medical devices","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"},{"edition":"EN 556-1:2024","list":"mdr","list_name":"Medical Devices Regulation","jurisdiction":"EU","title":"Sterilization of medical devices – Requirements for medical devices to be designated \"STERILE\" – Part 1: Requirements for terminally sterilized medical devices","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617"},{"edition":"EN 556-1:2024","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices","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 556-1:2024","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices","annex":"S.I. 2002/618","pc_start":"17/01/2026","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-medical-devices"}],"events":[{"date":"2025-04-10","type":"added","ref":"EN 556-1:2024","leg_slug":"ivdr","leg_name":"IVD Regulation"},{"date":"2025-04-09","type":"added","ref":"EN 556-1:2024","leg_slug":"mdr","leg_name":"Medical Devices Regulation"}],"generated":"2026-08-16 23:54 UTC"}