{"standard":"EN ISO 10993-9","listings":[{"edition":"EN ISO 10993-9:2009","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)","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 10993-9:2021","list":"mdr","list_name":"Medical Devices Regulation","jurisdiction":"EU","title":"Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617"}],"events":[{"date":"2022-01-05","type":"added","ref":"EN ISO 10993-9:2021","leg_slug":"mdr","leg_name":"Medical Devices Regulation"}],"generated":"2026-08-16 23:54 UTC"}