{
  "url": "https://openlegislation.uk/eu-decision-2020-439/annex-I",
  "json_url": "https://openlegislation.uk/eu-decision-2020-439/annex-I.json",
  "legislation": "eudn/2020/439",
  "legislation_title": "Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council",
  "legislation_url": "https://openlegislation.uk/eu-decision-2020-439",
  "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 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\n4.\nEN ISO 11137-2:2015\nSterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)\n5.\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)\n6.\nEN 12322:1999\nIn vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media\nEN 12322:1999/A1:2001\n7.\nEN ISO 13408-1:2015\nAseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)\n8.\nEN ISO 13408-2:2018\nAseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)\n9.\nEN ISO 13408-3:2011\nAseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)\n10.\nEN ISO 13408-4:2011\nAseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)\n11.\nEN ISO 13408-5:2011\nAseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)\n12.\nEN ISO 13408-6:2011\nAseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)\n13.\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)\n14.\nEN ISO 13485:2016\nMedical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)\nEN ISO 13485:2016/AC:2018\n15.\nEN 13532:2002\nGeneral requirements for in vitro diagnostic medical devices for self-testing\n16.\nEN 13612:2002\nPerformance evaluation of in vitro diagnostic medical devices\nEN 13612:2002/AC:2002\n17.\nEN 13641:2002\nElimination or reduction of risk of infection related to in vitro diagnostic reagents\n18.\nEN 13975:2003\nSampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects\n19.\nEN 14136:2004\nUse of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures\n20.\nEN 14254:2004\nIn vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans\n21.\nEN 14820:2004\nSingle-use containers for human venous blood specimen collection\n22.\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)\n23.\nEN ISO 14971:2012\nMedical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)\n24.\nEN ISO 15193:2009\nIn vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)\n25.\nEN ISO 15194:2009\nIn vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)\n26.\nEN ISO 15197:2015\nIn vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)\n27.\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)\n28.\nEN ISO 17511:2003\nIn vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)\n29.\nEN ISO 18113-1:2011\nIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)\n30.\nEN ISO 18113-2:2011\nIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)\n31.\nEN ISO 18113-3:2011\nIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)\n32.\nEN ISO 18113-4:2011\nIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)\n33.\nEN ISO 18113-5:2011\nIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)\n34.\nEN ISO 18153:2003\nIn vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)\n35.\nEN ISO 20776-1:2006\nClinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)\n36.\nEN ISO 23640:2015\nIn vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)\n37.\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)\n38.\nEN 61010-2-101:2002\nSafety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment\n39.\nEN 61326-2-6:2006\nElectrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment\n40.\nEN 62304:2006\nMedical device software - Software life-cycle processes (IEC 62304:2006)\nEN 62304:2006/AC:2008\n41.\nEN 62366:2008\nMedical devices - Application of usability engineering to medical devices",
  "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/2020/439/annex/I",
    "retrieved_at": "2026-11-01T15:12:20.417353+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."
}