{
  "url": "https://openlegislation.uk/eu-decision-2020-437/annex-II",
  "json_url": "https://openlegislation.uk/eu-decision-2020-437/annex-II.json",
  "legislation": "eudn/2020/437",
  "legislation_title": "Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC",
  "legislation_url": "https://openlegislation.uk/eu-decision-2020-437",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": null,
  "text": "No\nReference of the standard\n1.\nEN ISO 10993-11:2009\nBiological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)\n2.\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)\n3.\nEN ISO 11990-1:2014\nLasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)\n4.\nEN ISO 11990-2:2014\nLasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)\n5.\nEN ISO 13408-2:2011\nAseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)\n6.\nEN ISO 13485:2016\nMedical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)\nEN ISO 13485:2016/AC:2016\n7.\nEN 13976-2:2011\nRescue systems - Transportation of incubators - Part 2: System requirements\n8.\nEN 14683:2005\nSurgical masks - Requirements and test methods\n9.\nEN ISO 15747:2011\nPlastic containers for intravenous injections (ISO 15747:2010)\n10.\nEN ISO 15883-4:2009\nWasher-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)\n11.\nEN ISO 17664:2004\nSterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)\n12.\nEN ISO 21987:2009\nOphthalmic optics - Mounted spectacle lenses (ISO 21987:2009)",
  "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/2020/437/annex/II",
    "retrieved_at": "2026-11-01T15:12:20.503794+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."
}