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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 14971 Medical devices – Application of risk management to medical devices
  3. EN ISO 15223-1 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

TABLE 1
Reference information

Deadline for the adoption by 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 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

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

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

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

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

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

9.

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

27/5/2024

10.

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

27/5/2024

11.

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

27/5/2024

12.

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

27/5/2024

13.

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

27/5/2024

14.

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

27/5/2024

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

16.

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

26/5/2020

17.

EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

27/5/2024

18.

EN 13612:2002+AC:2002 Performance evaluation of in vitro diagnostic medical devices

27/5/2024

19.

EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents

27/5/2024

20.

EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices – Statistical aspects

27/5/2024

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

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

23.

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

26/5/2020

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

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

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

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

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

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

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

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

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

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

34.

EN ISO 18113-5:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In

30/9/2021

 

vitro diagnostic instruments for self-testing

 

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

36.

EN ISO 23640:2015 In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents

27/5/2024

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

38.

EN 62304:2018 Medicaldevice processes software – Software life-cycle

27/5/2024

39.

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.

Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664-1)

27/5/2024

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

3.

In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916)

26/5/2022