{"standard":"EN ISO 11607-2","listings":[{"edition":"EN ISO 11607-2:2006","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)","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 11607-2:2020","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"},{"edition":"EN ISO 11607-2:2020","list":"mdr","list_name":"Medical Devices Regulation","jurisdiction":"EU","title":"Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617"},{"edition":"EN ISO 11607-2:2020","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes","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":"2024-03-08","type":"added","ref":"EN ISO 11607-2:2020","leg_slug":"mdr","leg_name":"Medical Devices Regulation"},{"date":"2024-03-08","type":"added","ref":"EN ISO 11607-2:2020","leg_slug":"ivdr","leg_name":"IVD Regulation"}],"generated":"2026-08-16 23:54 UTC"}