Annex I

United Kingdom

No	Reference of the standard
1.	EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices EN 556-1:2001/AC:2006
2.	EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
3.	EN 1041:2008 Information supplied by the manufacturer of medical devices
4.	EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) EN ISO 10993-1:2009/AC:2010
5.	EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
6.	EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
7.	EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
8.	EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
9.	EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) EN ISO 10993-7:2008/AC:2009
10.	EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
11.	EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
12.	EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
13.	EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
14.	EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
15.	EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
16.	EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
17.	EN ISO 11135-1:2007 Sterilization 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)
18.	EN ISO 11137-1:2015 Sterilization 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) EN ISO 11137-1:2015/A2:2019
19.	EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
20.	EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
21.	EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
22.	EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
23.	EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
24.	EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN ISO 11737-1:2006/AC:2009
25.	EN ISO 11737-2:2009 Sterilization 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)
26.	EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
27.	EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
28.	EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
29.	EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
30.	EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
31.	EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
32.	EN ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
33.	EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/AC:2018
34.	EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) EN ISO 14155:2011/AC:2011
35.	EN ISO 14937:2009 Sterilization 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)
36.	EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
37.	EN ISO 15223-1:2016 Medical 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)
38.	EN ISO 17665-1:2006 Sterilization 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)
39.	EN ISO 25424:2019 Sterilization 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)
40.	EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
41.	EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
42.	EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) EN 45502-2-2:2008/AC:2009 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
43.	EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
44.	EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) EN 60601-1:2006/AC:2010 EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)
45.	EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
46.	EN 62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006) EN 62304:2006/AC:2008 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.