{
  "url": "https://openlegislation.uk/eu-decision-2020-438/annex-I",
  "json_url": "https://openlegislation.uk/eu-decision-2020-438/annex-I.json",
  "legislation": "eudn/2020/438",
  "legislation_title": "Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC",
  "legislation_url": "https://openlegislation.uk/eu-decision-2020-438",
  "path": "annex/I",
  "kind": "annex",
  "number": "I",
  "heading": null,
  "text": "No\nReference of the standard\n1.\nEN 556-1:2001\nSterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices\nEN 556-1:2001/AC:2006\n2.\nEN 556-2:2015\nSterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 2: Requirements for aseptically processed medical devices\n3.\nEN 1041:2008\nInformation supplied by the manufacturer of medical devices\n4.\nEN ISO 10993-1:2009\nBiological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)\nEN ISO 10993-1:2009/AC:2010\n5.\nEN ISO 10993-3:2014\nBiological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)\n6.\nEN ISO 10993-4:2009\nBiological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)\n7.\nEN ISO 10993-5:2009\nBiological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)\n8.\nEN ISO 10993-6:2009\nBiological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)\n9.\nEN ISO 10993-7:2008\nBiological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)\nEN ISO 10993-7:2008/AC:2009\n10.\nEN ISO 10993-9:2009\nBiological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)\n11.\nEN ISO 10993-11:2018\nBiological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)\n12.\nEN ISO 10993-12:2012\nBiological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)\n13.\nEN ISO 10993-13:2010\nBiological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)\n14.\nEN ISO 10993-16:2010\nBiological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)\n15.\nEN ISO 10993-17:2009\nBiological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)\n16.\nEN ISO 10993-18:2009\nBiological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)\n17.\nEN ISO 11135-1:2007\nSterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)\n18.\nEN ISO 11137-1:2015\nSterilization 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)\nEN ISO 11137-1:2015/A2:2019\n19.\nEN ISO 11137-2:2015\nSterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)\n20.\nEN ISO 11138-2:2009\nSterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)\n21.\nEN ISO 11138-3:2009\nSterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)\n22.\nEN ISO 11140-1:2009\nSterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)\n23.\nEN ISO 11607-1:2009\nPackaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)\n24.\nEN ISO 11737-1:2006\nSterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)\nEN ISO 11737-1:2006/AC:2009\n25.\nEN ISO 11737-2:2009\nSterilization 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)\n26.\nEN ISO 13408-1:2015\nAseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)\n27.\nEN ISO 13408-2:2018\nAseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)\n28.\nEN ISO 13408-3:2011\nAseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)\n29.\nEN ISO 13408-4:2011\nAseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)\n30.\nEN ISO 13408-5:2011\nAseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)\n31.\nEN ISO 13408-6:2011\nAseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)\n32.\nEN ISO 13408-7:2015\nAseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)\n33.\nEN ISO 13485:2016\nMedical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)\nEN ISO 13485:2016/AC:2018\n34.\nEN ISO 14155:2011\nClinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)\nEN ISO 14155:2011/AC:2011\n35.\nEN ISO 14937:2009\nSterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)\n36.\nEN ISO 14971:2012\nMedical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)\n37.\nEN ISO 15223-1:2016\nMedical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)\n38.\nEN ISO 17665-1:2006\nSterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)\n39.\nEN ISO 25424:2019\nSterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)\n40.\nEN 45502-1:1997\nActive implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer\n41.\nEN 45502-2-1:2003\nActive implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n42.\nEN 45502-2-2:2008\nActive implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)\nEN 45502-2-2:2008/AC:2009\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n43.\nEN 45502-2-3:2010\nActive implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n44.\nEN 60601-1:2006\nMedical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)\nEN 60601-1:2006/AC:2010\nEN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)\n45.\nEN 60601-1-6:2010\nMedical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.\n46.\nEN 62304:2006\nMedical device software - Software life-cycle processes (IEC 62304:2006)\nEN 62304:2006/AC:2008\nNotice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2020/438/annex/I",
    "retrieved_at": "2026-11-01T15:12:20.446130+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}