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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:

  1. EN ISO 13485  Medical devices – Quality management systems – Requirements for regulatory purposes
  2. EN ISO 14155  Clinical investigation of medical devices for human subjects – Good clinical practice
  3. EN ISO 14971 Medical devices – Application of risk management to medical devices
  4. EN ISO 15223-1 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
  5. EN 15986 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates

 

TABLE 1
Reference information

Deadline for the adoptionby the ESOs

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

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

3.

EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

27/5/2024

4.

EN ISO 10993-3:2014 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductivetoxicity

27/5/2024

5.

EN ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood

27/5/2024

6.

EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity

27/5/2024

7.

EN ISO 10993-6:2016 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation

27/5/2024

8.

EN ISO 10993-7:2008+AC:2009 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals

27/5/2024

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

10.

EN ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

27/5/2024

11.

EN ISO 10993-11:2018 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

27/5/2024

12.

EN ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

27/5/2024

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

14.

EN ISO 10993-14:2009 Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics

27/5/2024

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

16.

EN ISO 10993-16:2017 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables

27/5/2024

17.

EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances

27/5/2024

18.

EN ISO 10993-18:2009 Biological evaluation of medical devices – Part 18: Chemical characterization of materials

27/5/2024

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

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

21.

EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose

27/5/2024

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

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

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

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

26.

EN ISO 13408-1:2015 Aseptic processing of health care products – Part 1: General requirements

27/5/2024

27.

EN ISO 13408-2:2018 Aseptic processing of health care products – Part 2: Filtration

27/5/2024

28.

EN ISO 13408-3:2011 Aseptic processing of health care products – Part 3: Lyophilization

27/5/2024

29.

EN ISO 13408-4:2011 Aseptic processing of health care products – Part 4: Clean-in-place technologies

27/5/2024

30.

EN ISO 13408-5:2011 Aseptic processing of health care products – Part 5: Sterilization in place

27/5/2024

31.

EN ISO 13408-6:2011+A1:2013 Aseptic processing of health care products – Part 6: Isolator systems

27/5/2024

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

33.

EN ISO 13485:2016+AC:2018 Medical devices – Quality management systems – Requirements for regulatory purposes

26/5/2020

34.

EN ISO 14155:2011+AC:2011 Clinical investigation of medical devices for human subjects – Good clinical practice

26/5/2020

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

36.

EN ISO 14630:2012 Non-active surgical implants – General requirements

27/5/2024

37.

EN 14885:2018 Chemical disinfectants and antiseptics – Application of European standards for chemical disinfectants and antiseptics

27/5/2024

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

39.

EN ISO 14971:2012 Medical devices – Application of risk management to medical devices

26/5/2020

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

41.

EN 15986:2011 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates

26/5/2020

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

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

44.

EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management

27/5/2024

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

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

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

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

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

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

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

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

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

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

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

56.

EN 62304:2018 Medical      deviceprocesses software Software life-cycle

27/5/2024

57.

EN 62366-1:2015+AC:2016 Medical devices – Application of usability engineering to medical devices

27/5/2024

 

  TABLE 2
  Reference information

Deadline for the adoption by the ESOs

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

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

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

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

5.

prEN ISO 20417 Medical devices – Information to be provided by manufacturer (ISO 20417)

27/5/2024

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