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 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
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TABLE 1 |
Deadline for the adoption by 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 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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4. |
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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5. |
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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6. |
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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7. |
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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8. |
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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9. |
EN ISO 13408-1:2015 Aseptic processing of health care products – Part 1: General requirements |
27/5/2024 |
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10. |
EN ISO 13408-2:2018 Aseptic processing of health care products – Part 2: Filtration |
27/5/2024 |
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11. |
EN ISO 13408-3:2011 Aseptic processing of health care products – Part 3: Lyophilization |
27/5/2024 |
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12. |
EN ISO 13408-4:2011 Aseptic processing of health care products – Part 4: Clean-in-place technologies |
27/5/2024 |
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13. |
EN ISO 13408-5:2011 Aseptic processing of health care products – Part 5: Sterilization in place |
27/5/2024 |
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14. |
EN ISO 13408-6:2011+A1:2013 Aseptic processing of health care products – Part 6: Isolator systems |
27/5/2024 |
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15. |
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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16. |
EN ISO 13485:2016+AC:2018 Medical devices – Quality management systems – Requirements for regulatory purposes |
26/5/2020 |
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17. |
EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing |
27/5/2024 |
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18. |
EN 13612:2002+AC:2002 Performance evaluation of in vitro diagnostic medical devices |
27/5/2024 |
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19. |
EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
27/5/2024 |
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20. |
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices – Statistical aspects |
27/5/2024 |
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21. |
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
27/5/2024 |
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22. |
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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23. |
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices |
26/5/2020 |
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24. |
EN ISO 15193:2009 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for content and presentation of reference measurement procedures |
27/5/2024 |
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25. |
EN ISO 15194:2009 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation |
27/5/2024 |
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26. |
EN ISO 15197:2015 In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
27/5/2024 |
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27. |
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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28. |
EN ISO 17511:2003 In vitro diagnostic medical devices – requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
27/5/2024 |
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29. |
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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30. |
EN ISO 18113-1:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements |
30/9/2021 |
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31. |
EN ISO 18113-2:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use |
30/9/2021 |
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32. |
EN ISO 18113-3:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use |
30/9/2021 |
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33. |
EN ISO 18113-4:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing |
30/9/2021 |
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34. |
EN ISO 18113-5:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In |
30/9/2021 |
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vitro diagnostic instruments for self-testing |
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35. |
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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36. |
EN ISO 23640:2015 In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents |
27/5/2024 |
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37. |
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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38. |
EN 62304:2018 Medicaldevice processes software – Software life-cycle |
27/5/2024 |
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39. |
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. |
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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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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3. |
In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916) |
26/5/2022 |