Lista de normas armonizadas con IVDR: SR de la Comision Europea a los comités europeos de normalización

COMMISSION IMPLEMENTING DECISION on a (SR) standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council

Requested standardisation activities
1. The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are requested to revise the existing standards listed in Table 1 of Annex II to this Decision and to draft new standards listed in Table 2 of that Annex in support of Regulation (EU) 2017/746.

Table1: List of existing standards to be revised and deadlines for their adoption
Table2: List of new standards to be drafted and deadlines for their adoption

Estas tablas son las que puedes tomar como lista de normas armonizadas hasta su publicación en el DOUE.

TABLE 1 Reference information		Deadline for theadoption 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