Solicitud de revisión / elaboración de normas: Se pide al CEN y CENELEC que revisen las normas de la lista para su adopción como normas armonizadas
Tabla 1: Lista de normas existentes a revisar y fechas finales para su adopción
Tabla 2: Lista de nuevas normas a elaborar y fechas finales para su adopción
Estas tablas son las que puedes tomar como lista de normas armonizadas hasta su publicación en el DOUE. Las que han puesto como urgentes en primera convocatoria son:
- EN ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
- EN ISO 14155 Clinical investigation of medical devices for human subjects – Good clinical practice
- EN ISO 14971 Medical devices – Application of risk management to medical devices
- EN ISO 15223-1 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
- EN 15986 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates
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TABLE 1 |
Deadline for the adoptionby the ESOs |
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1. |
EN 556-1:2001+AC:2006 Sterilization of medical devices – Requirements for medical devices to be designated «STERILE» – Part 1: Requirements for terminally sterilized medical devices |
27/5/2024 |
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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 |
27/5/2024 |
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3. |
EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
27/5/2024 |
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4. |
EN ISO 10993-3:2014 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductivetoxicity |
27/5/2024 |
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5. |
EN ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood |
27/5/2024 |
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6. |
EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity |
27/5/2024 |
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7. |
EN ISO 10993-6:2016 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation |
27/5/2024 |
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8. |
EN ISO 10993-7:2008+AC:2009 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals |
27/5/2024 |
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9. |
EN ISO 10993-9:2009 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products |
27/5/2024 |
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10. |
EN ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization |
27/5/2024 |
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11. |
EN ISO 10993-11:2018 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity |
27/5/2024 |
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12. |
EN ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials |
27/5/2024 |
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13. |
EN ISO 10993-13:2010 Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices |
27/5/2024 |
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14. |
EN ISO 10993-14:2009 Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics |
27/5/2024 |
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15. |
EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys |
27/5/2024 |
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16. |
EN ISO 10993-16:2017 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables |
27/5/2024 |
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17. |
EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances |
27/5/2024 |
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18. |
EN ISO 10993-18:2009 Biological evaluation of medical devices – Part 18: Chemical characterization of materials |
27/5/2024 |
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19. |
EN ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices |
27/5/2024 |
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20. |
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 |
27/5/2024 |
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21. |
EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose |
27/5/2024 |
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22. |
EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems |
27/5/2024 |
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23. |
EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes |
27/5/2024 |
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24. |
EN ISO 11737-1:2018 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products |
27/5/2024 |
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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 |
27/5/2024 |
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26. |
EN ISO 13408-1:2015 Aseptic processing of health care products – Part 1: General requirements |
27/5/2024 |
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27. |
EN ISO 13408-2:2018 Aseptic processing of health care products – Part 2: Filtration |
27/5/2024 |
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28. |
EN ISO 13408-3:2011 Aseptic processing of health care products – Part 3: Lyophilization |
27/5/2024 |
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29. |
EN ISO 13408-4:2011 Aseptic processing of health care products – Part 4: Clean-in-place technologies |
27/5/2024 |
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30. |
EN ISO 13408-5:2011 Aseptic processing of health care products – Part 5: Sterilization in place |
27/5/2024 |
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31. |
EN ISO 13408-6:2011+A1:2013 Aseptic processing of health care products – Part 6: Isolator systems |
27/5/2024 |
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32. |
EN ISO 13408-7:2015 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products |
27/5/2024 |
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33. |
EN ISO 13485:2016+AC:2018 Medical devices – Quality management systems – Requirements for regulatory purposes |
26/5/2020 |
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34. |
EN ISO 14155:2011+AC:2011 Clinical investigation of medical devices for human subjects – Good clinical practice |
26/5/2020 |
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35. |
EN ISO 14160:2011 Sterilization of health care products – Liquid chemical sterilizing agents forsingle-use medical devicesutilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
27/5/2024 |
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36. |
EN ISO 14630:2012 Non-active surgical implants – General requirements |
27/5/2024 |
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37. |
EN 14885:2018 Chemical disinfectants and antiseptics – Application of European standards for chemical disinfectants and antiseptics |
27/5/2024 |
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38. |
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 |
27/5/2024 |
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39. |
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices |
26/5/2020 |
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40. |
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 |
26/5/2020 |
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41. |
EN 15986:2011 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates |
26/5/2020 |
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42. |
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 |
27/5/2024 |
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43. |
EN ISO 20857:2013 Sterilization of health care products – Dry heat – Requirements for the development, validation and routine control of a sterilization process for medical devices |
27/5/2024 |
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44. |
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management |
27/5/2024 |
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45. |
EN ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling |
27/5/2024 |
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46. |
EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy |
27/5/2024 |
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47. |
EN ISO 25424:2011 Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices |
27/5/2024 |
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48. |
EN 60601-1:2006 + AC:2010 + A1:2013+A12:2014 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
27/5/2024 |
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49. |
EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests |
27/5/2024 |
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50. |
EN 60601-1-3:2008+AC:2010+A11:2016 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment |
27/5/2024 |
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51. |
EN 60601-1-6:2010+A1:2015 Medical electrical equipment – Part 1-6: General requirements for basic safety and essentialperformance – Collateral standard: Usability |
27/5/2024 |
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52. |
EN 60601-1-8:2007+AC:2010+A11:2017+prA2 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
27/5/2024 |
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53. |
EN 60601-1-10:2008+A1:2015 Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loopcontroller |
27/5/2024 |
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54. |
EN 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcareenvironment |
27/5/2024 |
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55. |
EN 60601-1-12:2015 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergencymedical services environment |
27/5/2024 |
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56. |
EN 62304:2018 Medical deviceprocesses software Software life-cycle |
27/5/2024 |
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57. |
EN 62366-1:2015+AC:2016 Medical devices – Application of usability engineering to medical devices |
27/5/2024 |
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TABLE 2 |
Deadline for the adoption by the ESOs |
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1. |
prEN ISO 10993-23 Biological evaluation of medical devices – Part 23: Determination of skin irritation of medical device extracts using Reconstructed human Epidermis (RhE) (ISO 10993-23) |
27/5/2024 |
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2. |
ISO 14708-1 Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (ISO 14708-1) |
27/5/2024 |
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3. |
ISO 17664-1 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664-1) |
27/5/2024 |
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4. |
ISO 17664-2 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Medical devices not intended for direct patient contact (ISO 17664-2) |
27/5/2024 |
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5. |
prEN ISO 20417 Medical devices – Information to be provided by manufacturer (ISO 20417) |
27/5/2024 |
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6. |
ISO 23908 Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908) |
27/5/2024 |