EUROPEAN

COMMISSION

M/575
Brussels, 14.4.2021
C(2021) 2406 final

COMMISSION IMPLEMENTING DECISION

of 14.4.2021

on a standardisation request to the European Committee for Standardization 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

(Only the English, French and German texts are authentic)

EN EN
 COMMISSION IMPLEMENTING DECISION

of 14.4.2021

on a standardisation request to the European Committee for Standardization 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

(Only the English, French and German texts are authentic)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the
Council of 25 October 2012 on European standardisation, amending Council Directives
89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,
98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European
Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No
1673/2006/EC of the European Parliament and of the Council1, and in particular Article 10(1)
thereof,
Whereas:
(1) Regulation (EU) 2017/745 of the European Parliament and of the Council2 lays down
safety and performance requirements for medical devices for human use and system
and process requirements for economic operators and sponsors of clinical
investigations, in order to ensure a high level of protection of health and safety for
patients and users and the smooth functioning of the internal market. Regulation (EU)
2017/746 of the European Parliament and of the Council3 lays down such
requirements for in vitro diagnostic medical devices for human use.
(2) In accordance with Article 8(1) of Regulation (EU) 2017/745 and Article 8(1) of
Regulation (EU) 2017/746, devices and economic operators or sponsors that are in
conformity with the relevant harmonised standards or the relevant parts thereof, the
references of which have been published in the Official Journal of the European
Union, are to be presumed to be in conformity with the requirements of Regulations
(EU) 2017/745 or (EU) 2017/746 covered by those standards or parts thereof.
(3) Harmonised standards help ensuring a high level of protection of the health and safety
for patients and users throughout the Union and thus contribute to the free movement
of devices in the Union. Given that such standards are technology-neutral and

1
OJ L 316, 14.11.2012, p. 12.
2
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
3
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
(OJ L 117, 5.5.2017, p. 176).

EN 1 EN
 performance-based, they also contribute to ensuring equal conditions of competition
among economic operators dealing with devices, in particular small and medium-sized
enterprises that are active in this sector. Indirectly, those standards also contribute to
lower sales costs, benefitting patients and users in particular.
(4) Regulation (EU) 2017/745 replacing Council Directive 90/385/EEC 4 and Council
Directive 93/42/EEC5, and Regulation (EU) 2017/746 replacing Directive 98/79/EC of
the European Parliament and of the Council6 modify, among others, the requirements
regarding design and manufacture of devices, labelling and instructions for use of such
devices, and clinical investigation and performance studies concerning such devices.
Those Regulations also modify the rules on the quality management system and set
out detailed principles for the risk management requiring reduction of risks as far as
possible without adversely affecting the benefit-risk ratio.
(5) Several harmonised standards have been drafted in support of Directives 90/385/EEC,
93/42/EEC and 98/79/EC on the basis of standardisation mandates issued by the
Commission. Those harmonised standards need to be revised to take into account the
requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746.
(6) Standards developed at international level by the International Organization for
Standardization (ISO) and the International Electrotechnical Commission (IEC) on the
basis of the Vienna agreement7 and the Frankfurt agreement8 need to be adopted as
harmonised standards by the European Committee for Standardization (CEN) and the
European Committee for Electrotechnical Standardization (Cenelec) after adapting
them to the Union legal framework.
(7) It is also necessary to draft new harmonised standards in relation to the requirements
set out in Regulations (EU) 2017/745 and (EU) 2017/746.
(8) The intention to request a review or an update of the existing harmonised standards
and drafting of new harmonised standards in support of Regulations (EU) 2017/745
and (EU) 2017/746 is stated in point 18 of the Commission Staff Working Document
on the implementation of the actions foreseen in the annual Union work programme
for European standardisation for 20189 accompanying that programme10.
(9) CEN and Cenelec have indicated that the work covered by the request falls within
their area of competence.
(10) It is therefore appropriate to request CEN and Cenelec to revise the existing
harmonised standards and to draft new harmonised standards in support of Regulations
(EU) 2017/745 and (EU) 2017/746.
(11) The harmonised standards should include detailed technical specifications in relation
to the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746,
especially with respect to the design and manufacture of devices, risk management and
the obligations on economic operators and sponsors, including those relating to quality

4
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States
relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
5
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
6
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro
diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
7
Agreement on technical co-operation between ISO and CEN (Version 3.3 of 20 September 2001).
8
IEC-CENELEC Agreement on common planning of new work and parallel voting (Edition 3 of
October 2016).
9
SWD(2017) 284 final of 25 August 2017.
10
COM(2017) 453 final of 25 August 2017.

EN 2 EN
 management systems, risk management, clinical investigations and performance
studies, and clinical evaluation and clinical evidence. They should also indicate clearly
the correspondence between the technical specifications and the requirements they aim
to cover.
(12) In accordance with point 1 of Chapter I of Annex I to Regulation (EU) 2017/745 and
point 1 of Chapter I of Annex I to Regulation (EU) 2017/746, devices are to be safe
and effective and not compromise the clinical condition or the safety of patients, or the
safety and health of users or, where applicable, other persons, provided that any risks
which may be associated with their use constitute acceptable risks when weighed
against the benefits to the patient and are compatible with a high level of protection of
health and safety, taking into account the generally acknowledged state of the art.
Technical specifications included in the harmonised standards should support the
attainment of those objectives.
(13) In accordance with point (h) of section 23.1 of Chapter III of Annex I to Regulation
(EU) 2017/745 and point (h) of section 20.1 of Chapter III of Annex I to Regulation
(EU) 2017/746, the information supplied by the manufacturer of the device is to take
the form of internationally recognised symbols conforming to the harmonised
standards or common specifications. Moreover, in accordance with Article 10(11) of
Regulation (EU) 2017/745 and Article 10(10) of Regulation (EU) 2017/746, the use of
symbols in device information is to take into account the intended users or patients. In
order to ensure that users, patients and economic operators understand correctly the
meaning of any such symbols, a description of the meaning of the symbols should be
publicly available, without prejudice to any copyright to the relevant harmonised
standard or its parts.
(14) Information as to which legal requirements are covered or partially covered by a
harmonised standard is necessary when assessing, in accordance with Article 10(5) of
Regulation (EU) No 1025/2012, the compliance of the documents drafted by CEN and
Cenelec. Such information is also necessary before publication of references of
harmonised standards in the Official Journal of the European Union in accordance
with Article 10(6) of Regulation (EU) No 1025/2012. In each harmonised standard,
CEN and Cenelec should therefore specify the extent to which the technical
specifications included in the harmonised standard aim to cover one or several
requirements set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746.
(15) The European standardisation organisations have agreed to follow the Guidelines for
the execution of standardisation requests11.
(16) In order to ensure transparency and facilitate the execution of the requested
standardisation activities, CEN and Cenelec should prepare a work programme and
submit it to the Commission.
(17) In order to enable the Commission to better monitor the requested standardisation
work, CEN and Cenelec should provide the Commission with access to an overall
project plan containing detailed information on the execution of the standardisation
request and should report regularly on the execution of that request.
(18) Experience shows that during execution of the standardisation request, it may be
necessary to adjust the scope of the request or the deadlines set therein. CEN and
Cenelec should therefore promptly report to the Commission if they consider that
more time is required to draft the standards than initially foreseen or that it is
11
SWD(2015) 205 final of 27 October 2015.

EN 3 EN
 appropriate to adapt the scope of the request in order to allow the Commission to take
appropriate action.
(19) In accordance with Article 10(3) of Regulation (EU) No 1025/2012, each
standardisation request is subject to acceptance by the relevant European
standardisation organisation. It is therefore necessary to provide for rules on the
validity of this request if it is not accepted by CEN or Cenelec.
(20) In order to ensure legal certainty as to the validity of the request after its execution, it
is appropriate to provide for a date of expiry of this Decision.
(21) Given that Directives 90/385/EEC and 93/42/EEC are repealed as of 26 May 2021 and
Directive 98/79/EC is repealed as of 26 May 2022, it is appropriate to provide for the
end of validity of standardisation mandates that have been issued by the Commission
for drafting harmonised standards in support of those Directives.
(22) Given that a standardisation request as regards medical devices in support of
Regulations (EU) 2017/745 and (EU) 2017/746 set out in Implementing Decision
C(2020) 253212 was not accepted by CEN and Cenelec, it is appropriate to repeal that
Decision.
(23) The European standardisation organisations, the European stakeholders’ organisations
receiving Union financing, and the Medical Device Coordination Group established by
Article 103 of Regulation (EU) 2017/745 have been consulted.
(24) Article 5(1) of Implementing Decision C(2020) 2532 contains an error by providing
for expiry of standardisation mandate ‘M/321 of 13 June 2002’ on 26 May 2020.
Mandate ‘M/321 of 13 June 2002’ is also referred to in Article 5(2) of Implementing
Decision C(2020) 2532 providing for its expiry on 26 May 2022, which is the correct
expiry date.
(25) The measures provided for in this Decision are in accordance with the opinion of the
Committee established by Article 22 of Regulation (EU) No 1025/2012,
HAS ADOPTED THIS DECISION:
Article 1
Requested standardisation activities
1. The European Committee for Standardization (CEN) and the European Committee
for Electrotechnical Standardization (Cenelec) are requested to revise the existing
harmonised standards listed in Table 1 of Annex I to this Decision and to draft the
new harmonised standards listed in Table 2 of that Annex in support of Regulation
(EU) 2017/745 for medical devices by the deadlines set in that Annex.
2. CEN and Cenelec are requested to revise the existing standards listed in Table 1 of
Annex II to this Decision and to draft the new harmonised standards listed in Table 2
of that Annex in support of Regulation (EU) 2017/746 for in vitro diagnostic medical
devices by the deadlines set in that Annex.
3. The standards referred to in paragraphs 1 and 2 shall meet the requirements set out in
Annex III.

12
Commission Implementing Decision C(2020) 2532 of 15 May 2020 on a standardisation request to the
European Committee for Standardization 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.

EN 4 EN
 4. CEN and Cenelec shall provide the Commission with the titles of the requested
standards in all official languages of the Union.
Article 2
Work programme
1. CEN and Cenelec shall prepare a joint work programme indicating all the standards
listed in Annexes I and II, the responsible technical bodies and a timetable for the
execution of the requested standardisation activities in line with the deadlines set out
in those Annexes.
2. CEN and Cenelec shall submit the joint work programme to the Commission by 28
May 2021. CEN and Cenelec shall inform the Commission of any amendments to the
joint work programme.
3. CEN and Cenelec shall provide the Commission with access to an overall project
plan.
Article 3
Reporting
1. CEN and Cenelec shall report annually to the Commission on the execution of the
standardisation request referred to in Article 1, indicating the progress made in
implementation of the work programme referred to in Article 2.
2. CEN and Cenelec shall submit the first joint annual report to the Commission by 16
April 2022. Subsequent joint annual reports shall be submitted to the Commission by
31 October each year.
3. CEN and Cenelec shall provide the Commission with the joint final report by 30
June 2024.
4. CEN and Cenelec shall promptly report to the Commission any major concerns
relating to the scope of the standardisation request referred to in Article 1 or the
deadlines set in Annexes I and II.
Article 4
Validity of the standardisation request
If CEN or Cenelec do not accept the standardisation request referred to in Article 1 within a
month of receiving it, the request may not constitute a basis for the standardisation activities
referred to in that Article.
This Decision shall expire on 31 December 2024.
Article 5
Expiry of existing standardisation mandates and repeal of Implementing Decision C(2020)
2532
1. The following standardisation mandates shall expire on 26 May 2022:
(a) M/252 of 12 September 1997;
(b) M/321 of 13 June 2002;
(c) M/384 of 6 April 2006.
2. Implementing Decision C(2020) 2532 is repealed.

EN 5 EN
 Article 6
Addressees
This Decision is addressed to the European Committee for Standardization and the European
Committee for Electrotechnical Standardization.
Done at Brussels, 14.4.2021

For the Commission

Stella KYRIAKIDES
Member of the Commission

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 EUROPEAN
COMMISSION

Brussels, 14.4.2021
C(2021) 2406 final

ANNEXES 1 to 3

ANNEXES

to the

COMMISSION IMPLEMENTING DECISION

on a standardisation request to the European Committee for Standardization 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

EN EN
 ANNEX I
List of existing standards to be revised and list of new standards to be drafted as
referred to in Article 1(1)

Table 1: List of existing harmonised standards to be revised and deadlines for the
adoption of the revised harmonised standards

Reference information Deadline for the adoption

1. EN 285:2015 27 May 2024

Sterilization - Steam sterilizers - Large sterilizers

2. EN 455-1:2020 27 May 2024

Medical gloves for single use - Part 1: Requirements

and testing for freedom from holes

3. EN 455-2:2015 27 May 2024

Medical gloves for single use - Part 2: Requirements

and testing for physical properties

4. EN 455-3:2015 27 May 2024

Medical gloves for single use - Part 3: Requirements

and testing for biological evaluation

5. EN 455-4:2009 27 May 2024

Medical gloves for single use - Part 4: Requirements

and testing for shelf life determination

6. EN 556-1:2001+AC:2006 27 May 2024

Sterilization of medical devices - Requirements for

medical devices to be designated "STERILE" - Part 1:
Requirements for terminally sterilized medical devices

7. EN 556-2:2015 27 May 2024

Sterilization of medical devices - Requirements for

medical devices to be designated ''STERILE" - Part 2:
Requirements for aseptically processed medical
devices

8. EN 1422:2014 27 May 2024

Sterilizers for medical purposes - Ethylene oxide

sterilizers - Requirements and test methods

EN 1 EN
 9. EN 1865-1:2010+A1:2015 27 May 2024

Patient handling equipment used in road ambulances -

Part 1: General stretcher systems and patient handling
equipment

10. EN 1865-2:2010+A1:2015 27 May 2024

Patient handling equipment used in road ambulances -

Part 2: Power assisted stretcher

11. EN 1865-3:2012+A1:2015 27 May 2024

Patient handling equipment used in road ambulances -

Part 3: Heavy duty stretcher

12. EN 1865-4:2012 27 May 2024

Patient handling equipment used in road ambulances -

Part 4: Foldable patient transfer chair

13. EN 1985:1998 27 May 2024

Walking aids - General requirements and test methods

14. EN ISO 4074:2015 27 May 2024

Natural rubber latex male condoms - Requirements

and test methods

15. EN ISO 5359:2014+A1:2017 27 May 2024

Anaesthetic and respiratory equipment - Low-pressure

hose assemblies for use with medical gases

16. EN ISO 5840-1:2015 27 May 2024

Cardiovascular implants - Cardiac valve prostheses -

Part 1: General requirements

17. EN ISO 5840-2:2015 27 May 2024

Cardiovascular implants - Cardiac valve prostheses -

Part 2: Surgically implanted heart valve substitutes

18. EN ISO 5840-3:2013 27 May 2024

Cardiovascular implants - Cardiac valve prostheses -

Part 3: Heart valve substitutes implanted by
transcatheter techniques

19. EN ISO 7010:2020+A1:2020 27 May 2024

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 Graphical symbols - Safety colours and safety signs -
Registered safety signs

20. EN ISO 7197:2009 27 May 2024

Neurosurgical implants - Sterile, single-use

hydrocephalus shunts and components

21. EN ISO 7396-1:2016+A1:2019 27 May 2024

Medical gas pipeline systems - Part 1: Pipeline

systems for compressed medical gases and vacuum

22. EN ISO 7396-2:2007 27 May 2024

Medical gas pipeline systems - Part 2: Anaesthetic gas

scavenging disposal systems

23. EN ISO 9713:2009 27 May 2024

Neurosurgical implants - Self-closing intracranial

aneurysm clips

24. EN ISO 10328:2016 27 May 2024

Prosthetics - Structural testing of lower-limb

prostheses - Requirements and test methods

25. EN ISO 10524-1:2019 27 May 2024

Pressure regulators for use with medical gases - Part 1:

Pressure regulators and pressure regulators with flow-
metering devices

26. EN ISO 10524-2:2019 27 May 2024

Pressure regulators for use with medical gases - Part 2:

Manifold and line pressure regulators

27. EN ISO 10524-3:2019 27 May 2024

Pressure regulators for use with medical gases - Part 3:

Pressure regulators integrated with cylinder valves
(VIPRs)

28. EN ISO 10535:2006 27 May 2024

Hoists for the transfer of disabled persons -

Requirements and test methods

29. EN ISO 10993-1:2020 27 May 2024

Biological evaluation of medical devices - Part 1:

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 Evaluation and testing within a risk management
process

30. EN ISO 10993-3:2014 27 May 2024

Biological evaluation of medical devices - Part 3:

Tests for genotoxicity, carcinogenicity and
reproductive toxicity

31. EN ISO 10993-4:2017 27 May 2024

Biological evaluation of medical devices - Part 4:

Selection of tests for interactions with blood

32. EN ISO 10993-5:2009 27 May 2024

Biological evaluation of medical devices - Part 5:

Tests for in vitro cytotoxicity

33. EN ISO 10993-6:2016 27 May 2024

Biological evaluation of medical devices - Part 6:

Tests for local effects after implantation

34. EN ISO 10993-7:2008+AC:2009 27 May 2024

Biological evaluation of medical devices - Part 7:

Ethylene oxide sterilization residuals

35. EN ISO 10993-9:2009 27 May 2024

Biological evaluation of medical devices - Part 9:

Framework for identification and quantification of
potential degradation products

36. EN ISO 10993-10:2013 27 May 2024

Biological evaluation of medical devices - Part 10:

Tests for irritation and skin sensitization

37. EN ISO 10993-11:2018 27 May 2024

Biological evaluation of medical devices - Part 11:

Tests for systemic toxicity

38. EN ISO 10993-12:2012 27 May 2024

Biological evaluation of medical devices - Part 12:

Sample preparation and reference materials

39. EN ISO 10993-13:2010 27 May 2024

Biological evaluation of medical devices - Part 13:

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 Identification and quantification of degradation
products from polymeric medical devices

40. EN ISO 10993-14:2009 27 May 2024

Biological evaluation of medical devices - Part 14:

Identification and quantification of degradation
products from ceramics

41. EN ISO 10993-15:2009 27 May 2024

Biological evaluation of medical devices - Part 15:

Identification and quantification of degradation
products from metals and alloys

42. EN ISO 10993-16:2017 27 May 2024

Biological evaluation of medical devices - Part 16:

Toxicokinetic study design for degradation products
and leachables

43. EN ISO 10993-17:2009 27 May 2024

Biological evaluation of medical devices - Part 17:

Establishment of allowable limits for leachable
substances

44. EN ISO 10993-18:2020 27 May 2024

Biological evaluation of medical devices - Part 18:

Chemical characterization of materials

45. EN ISO 11135:2014+A1:2019 27 May 2024

Sterilization of health-care products - Ethylene oxide -

Requirements for the development, validation and
routine control of a sterilization process for medical
devices

46. EN ISO 11137-1:2015+A2:2019 27 May 2024

Sterilization of health care products - Radiation - Part

1: Requirements for development, validation and
routine control of a sterilization process for medical
devices

47. EN ISO 11137-2:2015 27 May 2024

Sterilization of health care products - Radiation - Part

2: Establishing the sterilization dose

EN 5 EN
 48. EN ISO 11140-1:2014 27 May 2024

Sterilization of health care products - Chemical

indicators - Part 1: General requirements

49. EN ISO 11140-3:2009 27 May 2024

Sterilization of health care products - Chemical

indicators - Part 3: Class 2 indicator systems for use in
the Bowie and Dick-type steam penetration test

50. EN ISO 11140-4:2007 27 May 2024

Sterilization of health care products - Chemical

indicators - Part 4: Class 2 indicators as an alternative
to the Bowie and Dick-type test for detection of steam
penetration

51. EN ISO 11197:2019 27 May 2024

Medical supply units

52. EN ISO 11607-1:2020 27 May 2024

Packaging for terminally sterilized medical devices -

Part 1: Requirements for materials, sterile barrier
systems and packaging systems

53. EN ISO 11607-2:2020 27 May 2024

Packaging for terminally sterilized medical devices -

Part 2: Validation requirements for forming, sealing
and assembly processes

54. EN ISO 11737-1:2018 27 May 2024

Sterilization of medical devices - Microbiological

methods - Part 1: Determination of a population of
microorganisms on products

55. EN ISO 11737-2:2020 27 May 2024

Sterilization of medical devices - Microbiological

methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization
process

56. EN ISO 11810:2015 27 May 2024

Lasers and laser-related equipment - Test method and

classification for the laser resistance of surgical drapes
and/or patient protective covers - Primary ignition,

EN 6 EN
 penetration, flame spread and secondary ignition

57. EN ISO 11990:2018 27 May 2024

Lasers and laser-related equipment - Determination of

laser resistance of tracheal tube shaft and tracheal cuffs

58. EN 12183:2014 27 May 2024

Manual wheelchairs - Requirements and test methods

59. EN 12184:2014 27 May 2024

Electrically powered wheelchairs, scooters and their

chargers - Requirements and test methods

60. EN ISO 12417-1:2015 27 May 2024

Cardiovascular implants and extracorporeal systems -

Vascular device-drug combination products - Part 1:
General requirements

61. EN ISO 12870:2018 27 May 2024

Ophthalmic optics - Spectacle frames - Requirements

and test methods

62. EN 13060:2014+A1:2018 27 May 2024

Small steam sterilizers

63. EN ISO 13408-1:2015 27 May 2024

Aseptic processing of health care products - Part 1:
General requirements

64. EN ISO 13408-2:2018 27 May 2024

Aseptic processing of health care products - Part 2:

Filtration

65. EN ISO 13408-3:2011 27 May 2024

Aseptic processing of health care products - Part 3:
Lyophilization

66. EN ISO 13408-4:2011 27 May 2024

Aseptic processing of health care products - Part 4:

Clean-in-place technologies

67. EN ISO 13408-5:2011 27 May 2024

EN 7 EN
 Aseptic processing of health care products - Part 5:
Sterilization in place

68. EN ISO 13408-6:2011+A1:2013 27 May 2024

Aseptic processing of health care products - Part 6:

Isolator systems

69. EN ISO 13408-7:2015 27 May 2024

Aseptic processing of health care products - Part 7:

Alternative processes for medical devices and
combination products

70. EN ISO 13485:2016+AC:2018 27 May 2024

Medical devices - Quality management systems -

Requirements for regulatory purposes

71. EN 13718-1:2014+A1:2020 27 May 2024

Medical vehicles and their equipment - Air

ambulances - Part 1: Requirements for medical devices
used in air ambulances

72. EN 13795-1:2019 27 May 2024

Surgical clothing and drapes - Requirements and test

methods - Part 1: Surgical drapes and gowns

73. EN 13795-2:2019 27 May 2024

Surgical clothing and drapes - Requirements and test

methods - Part 2: Clean air suits

74. EN 13976-1:2018 27 May 2024

Rescue systems - Transportation of incubators - Part 1:

Interface requirements

75. EN 13976-2:2018 27 May 2024

Rescue systems - Transportation of incubators - Part 2:

System requirements

76. EN 14139:2010 27 May 2024

Ophthalmic optics - Specifications for ready-to-wear

spectacles

77. EN ISO 14155:2020 27 May 2024

Clinical investigation of medical devices for human

EN 8 EN
 subjects - Good clinical practice

78. EN ISO 14160:2011 27 May 2024

Sterilization of health care products - Liquid chemical

sterilizing agents for single-use medical devices
utilizing animal tissues and their derivatives -
Requirements for characterization, development,
validation and routine control of a sterilization process
for medical devices

79. EN 14180:2014 27 May 2024

Sterilizers for medical purposes - Low temperature

steam and formaldehyde sterilizers - Requirements and
testing

80. EN ISO 14602:2011 27 May 2024

Non-active surgical implants - Implants for

osteosynthesis - Particular requirements

81. EN ISO 14607:2018 27 May 2024

Non-active surgical implants - Mammary implants -

Particular requirements

82. EN ISO 14630:2012 27 May 2024

Non-active surgical implants - General requirements

83. EN 14683:2019+AC:2019 27 May 2024

Medical face masks - Requirements and test methods

84. EN 14885:2018 27 May 2024

Chemical disinfectants and antiseptics - Application of

European standards for chemical disinfectants and
antiseptics

85. EN ISO 14889:2013+A1:2017 27 May 2024

Ophthalmic optics - Spectacle lenses - Fundamental

requirements for uncut finished lenses

86. EN ISO 14937:2009 27 May 2024

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

EN 9 EN
 87. EN ISO 14971:2019 27 May 2024

Medical devices - Application of risk management to

medical devices

88. EN ISO 15001:2011 27 May 2024

Anaesthetic and respiratory equipment - Compatibility

with oxygen

89. EN ISO 15004-1:2020 27 May 2024

Ophthalmic instruments - Fundamental requirements

and test methods - Part 1: General requirements
applicable to all ophthalmic instruments

90. EN ISO 15223-1:2016 27 May 2024

Medical devices - Symbols to be used with medical

device labels, labelling and information to be supplied
- Part 1: General requirements

91. EN ISO 15883-1:2009+A1:2014 27 May 2024

Washer-disinfectors - Part 1: General requirements,

terms and definitions and tests

92. EN ISO 15883-2:2009 27 May 2024

Washer-disinfectors - Part 2: Requirements and tests

for washer-disinfectors employing thermal disinfection
for surgical instruments, anaesthetic equipment, bowls,
dishes, receivers, utensils, glassware, etc.

93. EN ISO 15883-3:2009 27 May 2024

Washer-disinfectors - Part 3: Requirements and tests

for washer-disinfectors employing thermal disinfection
for human waste containers

94. EN ISO 15883-4:2018 27 May 2024

Washer-disinfectors - Part 4: Requirements and tests

for washer-disinfectors employing chemical
disinfection for thermolabile endoscopes

95. EN ISO 15883-6:2015 27 May 2024

Washer-disinfectors - Part 6: Requirements and tests

for washer-disinfectors employing thermal disinfection
for non-invasive, non-critical medical devices and
healthcare equipment

EN 10 EN
 96. EN ISO 15883-7:2016 27 May 2024

Washer-disinfectors - Part 7: Requirements and tests

for washer-disinfectors employing chemical
disinfection for non-invasive, non-critical thermolabile
medical devices and healthcare equipment

97. EN ISO 16061:2015 27 May 2024

Instrumentation for use in association with non-active

surgical implants - General requirements

98. EN ISO 17664:2017 27 May 2024

Processing of health care products - Information to be

provided by the medical device manufacturer for the
processing of medical devices

99. EN ISO 17665-1:2006 27 May 2024

Sterilization of health care products - Moist heat - Part

1: Requirements for the development, validation and
routine control of a sterilization process for medical
devices

100. EN ISO 18562-1:2020 27 May 2024

Biocompatibility evaluation of breathing gas pathways

in healthcare applications - Part 1: Evaluation and
testing within a risk management process

101. EN ISO 18562-2:2020 27 May 2024

Biocompatibility evaluation of breathing gas pathways

in healthcare applications - Part 2: Tests for emissions
of particulate matter

102. EN ISO 18562-3:2020 27 May 2024

Biocompatibility evaluation of breathing gas pathways

in healthcare applications - Part 3: Tests for emissions
of volatile organic compounds (VOCs)

103. EN ISO 18562-4:2020 27 May 2024

Biocompatibility evaluation of breathing gas pathways

in healthcare applications - Part 4: Tests for leachables
in condensate

104. EN ISO 20857:2013 27 May 2024

Sterilization of health care products - Dry heat -

EN 11 EN
 Requirements for the development, validation and
routine control of a sterilization process for medical
devices

105. EN ISO 21534:2009 27 May 2024

Non-active surgical implants - Joint replacement

implants - Particular requirements

106. EN ISO 21535:2009+A1:2016 27 May 2024

Non-active surgical implants - Joint replacement

implants - Specific requirements for hip-joint
replacement implants

107. EN ISO 21536:2009+A1:2014 27 May 2024

Non-active surgical implants - Joint replacement

implants - Specific requirements for knee-joint
replacement implants

108. EN ISO 21987:2017 27 May 2024

Ophthalmic optics - Mounted spectacle lenses

109. EN ISO 22442-1:2020 27 May 2024

Medical devices utilizing animal tissues and their

derivatives - Part 1: Application of risk management

110. EN ISO 22442-2:2020 27 May 2024

Medical devices utilizing animal tissues and their

derivatives - Part 2: Controls on sourcing, collection
and handling

111. EN ISO 22442-3:2007 27 May 2024

Medical devices utilizing animal tissues and their

derivatives - Part 3: Validation of the elimination
and/or inactivation of viruses and transmissible
spongiform encephalopathy (TSE) agents

112. EN ISO 22523:2006 27 May 2024

External limb prostheses and external orthoses -

Requirements and test methods

113. EN ISO 22675:2016 27 May 2024

Prosthetics - Testing of ankle-foot devices and foot

units - Requirements and test methods

EN 12 EN
 114. EN ISO 23908:2013 27 May 2024

Sharps injury protection - Requirements and test

methods - Sharps protection features for single-use
hypodermic needles, introducers for catheters and
needles used for blood sampling

115. EN ISO 25424:2019 27 May 2024

Sterilization of health care products - Low temperature

steam and formaldehyde - Requirements for
development, validation and routine control of a
sterilization process for medical devices

116. EN ISO 25539-1:2017 27 May 2024

Cardiovascular implants - Endovascular devices - Part

1: Endovascular prostheses

117. EN ISO 25539-2:2020 27 May 2024

Cardiovascular implants - Endovascular devices - Part

2: Vascular stents

118. EN ISO 25539-3:2011 27 May 2024

Cardiovascular implants - Endovascular devices - Part

3: Vena cava filters

119. EN 50637:2017 27 May 2024

Medical electrical equipment - Particular requirements

for the basic safety and essential performance of
medical beds for children

120. EN 60118-0:2015 27 May 2024

Electroacoustics - Hearing aids - Part 0: Measurement

of the performance characteristics of hearing aids

121. EN IEC 60118-13:2020 27 May 2024

Electroacoustics - Hearing aids - Part 13:

Requirements and methods of measurement for
electromagnetic immunity to mobile digital wireless
devices

122. EN 60601-1:2006+A1:2013+AC:2014+A12:2014 27 May 2024

+A2:2020

Medical electrical equipment - Part 1: General

requirements for basic safety and essential

EN 13 EN
 performance

123. EN 60601-1-2:2015+A1:2020 27 May 2024

Medical electrical equipment - Part 1-2: General

requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests

124. EN 60601-1-3:2008+AC:2014+A11:2016+A1:2020 27 May 2024

Medical electrical equipment - Part 1-3: General

requirements for basic safety and essential
performance - Collateral standard: Radiation
protection in diagnostic X-ray equipment

125. EN 60601-1-6:2010+A1:2015+A2:2020 27 May 2024

Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability

126. EN 60601-1-8:2007+AC:2014+A11:2017+A2:2020 27 May 2024

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

127. EN 60601-1-10:2008+A1:2015+A2:2020 27 May 2024

Medical electrical equipment - Part 1-10: General

requirements for basic safety and essential
performance - Collateral standard: Requirements for
the development of physiologic closed-loop controller

128. EN 60601-1-11:2015+A1:2020 27 May 2024

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 healthcare environment

129. EN 60601-1-12:2015+A1:2020 27 May 2024

Medical electrical equipment - Part 1-12: General

requirements for basic safety and essential
performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical

EN 14 EN
 systems intended for use in the emergency medical
services environment

130. EN 60601-2-1:2015 27 May 2024

Medical electrical equipment - Part 2-1: Particular

requirements for the basic safety and essential
performance of electron accelerators in the range 1
MeV to 50 MeV

131. EN IEC 60601-2-2:2018 27 May 2024

Medical electrical equipment - Part 2-2: Particular

requirements for the basic safety and essential
performance of high frequency surgical equipment and
high frequency surgical accessories

132. EN 60601-2-3:2015+A1:2016 27 May 2024

Medical electrical equipment - Part 2-3: Particular

requirements for the basic safety and essential
performance of short-wave therapy equipment

133. EN 60601-2-4:2011+A1:2019 27 May 2024

Medical electrical equipment - Part 2-4: Particular

requirements for the basic safety and essential
performance of cardiac defibrillators

134. EN 60601-2-5:2015 27 May 2024

Medical electrical equipment - Part 2-5: Particular

requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment

135. EN 60601-2-6:2015+A1:2016 27 May 2024

Medical electrical equipment - Part 2-6: Particular

requirements for the basic safety and essential
performance of microwave therapy equipment

136. EN 60601-2-8:2015+A1:2016 27 May 2024

Medical electrical equipment - Part 2-8: Particular

requirements for the basic safety and essential
performance of therapeutic X-ray equipment operating
in the range 10 kV to 1 MV

137. EN 60601-2-10:2015+A1:2016 27 May 2024

Medical electrical equipment - Part 2-10: Particular

requirements for the basic safety and essential

EN 15 EN
 performance of nerve and muscle stimulators

138. EN 60601-2-11:2015 27 May 2024

Medical electrical equipment - Part 2-11: Particular

requirements for the basic safety and essential
performance of gamma beam therapy equipment

139. EN IEC 60601-2-16:2019 27 May 2024

Medical electrical equipment - Part 2-16: Particular

requirements for the basic safety and essential
performance of haemodialysis, haemodiafiltration and
haemofiltration equipment

140. EN 60601-2-17:2015 27 May 2024

Medical electrical equipment - Part 2-17: Particular

requirements for the basic safety and essential
performance of automatically-controlled
brachytherapy afterloading equipment

141. EN 60601-2-18:2015 27 May 2024

Medical electrical equipment - Part 2-18: Particular

requirements for the basic safety and essential
performance of endoscopic equipment

142. EN IEC 60601-2-19:2020 27 May 2024

Medical electrical equipment - Part 2-19: Particular

requirements for the basic safety and essential
performance of infant incubators

143. EN IEC 60601-2-20:2020 27 May 2024

Medical electrical equipment - Part 2-20: Particular

requirements for the basic safety and essential
performance of infant transport incubators

144. EN IEC 60601-2-21:2020 27 May 2024

Medical electrical equipment - Part 2-21: Particular

requirements for the basic safety and essential
performance of infant radiant warmers

145. EN 60601-2-23:2015 27 May 2024

Medical electrical equipment - Part 2-23: Particular

requirements for the basic safety and essential
performance of transcutaneous partial pressure

EN 16 EN
 monitoring equipment

146. EN 60601-2-24:2015 27 May 2024

Medical electrical equipment - Part 2-24: Particular

requirements for the basic safety and essential
performance of infusion pumps and controllers

147. EN 60601-2-25:2015 27 May 2024

Medical electrical equipment - Part 2-25: Particular

requirements for the basic safety and essential
performance of electrocardiographs

148. EN 60601-2-27:2014 27 May 2024

Medical electrical equipment - Part 2-27: Particular

requirements for the basic safety and essential
performance of electrocardiographic monitoring
equipment

149. EN IEC 60601-2-28:2019 27 May 2024

Medical electrical equipment - Part 2-28: Particular

requirements for the basic safety and essential
performance of X-ray tube assemblies for medical
diagnosis

150. EN 60601-2-29:2008+A11:2011 27 May 2024

Medical electrical equipment - Part 2-29: Particular

requirements for the basic safety and essential
performance of radiotherapy simulators

151. EN IEC 60601-2-31:2020 27 May 2024

Medical electrical equipment - Part 2-31: Particular

requirements for the basic safety and essential
performance of external cardiac pacemakers with
internal power source

152. EN 60601-2- 27 May 2024

33:2010+A11:2011+A1:2015+A2:2015+A12:2016

Medical electrical equipment - Part 2-33: Particular

requirements for the basic safety and essential
performance of magnetic resonance equipment for
medical diagnosis

153. EN 60601-2-34:2014 27 May 2024

Medical electrical equipment - Part 2-34: Particular

EN 17 EN
 requirements for the basic safety and essential
performance of invasive blood pressure monitoring
equipment

154. EN 60601-2-36:2015 27 May 2024

Medical electrical equipment - Part 2-36: Particular

requirements for the basic safety and essential
performance of equipment for extracorporeally
induced lithotripsy

155. EN 60601-2-37:2008+A11:2011+A1:2015 27 May 2024

Medical electrical equipment - Part 2-37: Particular

requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment

156. EN IEC 60601-2-39:2019 27 May 2024

Medical electrical equipment - Part 2-39: Particular

requirements for basic safety and essential
performance of peritoneal dialysis equipment

157. EN 60601-2-40:2019 27 May 2024

Medical electrical equipment - Part 2-40: Particular

requirements for the basic safety and essential
performance of electromyographs and evoked response
equipment

158. EN 60601-2-41:2009+A11:2011+A1:2015 27 May 2024

Medical electrical equipment - Part 2-41: Particular

requirements for basic safety and essential
performance of surgical luminaires and luminaires for
diagnosis

159. EN 60601-2-43:2010+AC:2014+A1:2018+A2:2020 27 May 2024

Medical electrical equipment - Part 2-43: Particular

requirements for the basic safety and essential
performance of X-ray equipment for interventional
procedures

160. EN 60601-2-44:2009+A11:2011+A1:2012+A2:2016 27 May 2024

Medical electrical equipment - Part 2-44: Particular

requirements for the basic safety and essential
performance of X-ray equipment for computed
tomography

EN 18 EN
 161. EN 60601-2-45:2011+A1:2015 27 May 2024

Medical electrical equipment - Part 2-45: Particular

requirements for the basic safety and essential
performance of mammographic X-ray equipment and
mammographic stereotactic devices

162. EN IEC 60601-2-46:2019 27 May 2024

Medical electrical equipment - Part 2-46: Particular

requirements for the basic safety and essential
performance of operating tables

163. EN 60601-2-47:2015 27 May 2024

Medical electrical equipment - Part 2-47: Particular

requirements for the basic safety and essential
performance of ambulatory electrocardiographic
systems

164. EN 60601-2-50:2009+A11:2011+A1:2016 27 May 2024

Medical electrical equipment - Part 2-50: Particular

requirements for the basic safety and essential
performance of infant phototherapy equipment

165. EN 60601-2-52:2010+AC:2011+A1:2015 27 May 2024

Medical electrical equipment - Part 2-52: Particular

requirements for the basic safety and essential
performance of medical beds

166. EN 60601-2-54:2009+A1:2015+A2:2019 27 May 2024

Medical electrical equipment - Part 2-54: Particular

requirements for the basic safety and essential
performance of X-ray equipment for radiography and
radioscopy

167. EN 60601-2-62:2015 27 May 2024

Medical electrical equipment - Part 2-62: Particular

requirements for the basic safety and essential
performance of high intensity therapeutic ultrasound
(HITU) equipment

168. EN 60601-2-63:2015+A1:2019 27 May 2024

Medical electrical equipment - Part 2-63: Particular

requirements for the basic safety and essential
performance of dental extra-oral X-ray equipment

EN 19 EN
 169. EN 60601-2-64:2015 27 May 2024

Medical electrical equipment - Part 2-64: Particular

requirements for the basic safety and essential
performance of light ion beam medical electrical
equipment

170. EN 60601-2-65:2013+A1:2020 27 May 2024

Medical electrical equipment - Part 2-65: Particular

requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment

171. EN IEC 60601-2-66:2020 27 May 2024

Medical electrical equipment - Part 2-66: Particular

requirements for the basic safety and essential
performance of hearing aids and hearing aid systems

172. EN 60601-2-68:2015 27 May 2024

Medical electrical equipment - Part 2-68: Particular

requirements for the basic safety and essential
performance of X-ray-based image-guided
radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and
radionuclide beam therapy equipment

173. EN IEC 60601-2-75:2019 27 May 2024

Medical electrical equipment - Part 2-75: Particular

requirements for the basic safety and essential
performance of photodynamic therapy and
photodynamic diagnosis equipment

174. EN IEC 60601-2-76:2019 27 May 2024

Medical electrical equipment - Part 2-76: Particular

requirements for the basic safety and essential
performance of low energy ionized gas haemostasis
equipment

175. EN IEC 60601-2-83:2020 27 May 2024

Medical electrical equipment - Part 2-83: Particular

requirements for the basic safety and essential
performance of home light therapy equipment

176. EN 61010-1:2010+A1:2019+AC:2019 27 May 2024

Safety requirements for electrical equipment for

measurement, control, and laboratory use - Part 1:

EN 20 EN
 General requirements

177. EN 61326-1:2013 27 May 2024

Electrical equipment for measurement, control and

laboratory use - EMC requirements - Part 1: General
requirements

178. EN 62083:2009 27 May 2024

Medical electrical equipment - Requirements for the

safety of radiotherapy treatment planning systems

179. EN 62304:2006+A1:2015 27 May 2024

Medical device software - Software life-cycle

processes

180. EN 62366-1:2015+AC:2015+AC:2016+A1:2020 27 May 2024

Medical devices - Application of usability engineering

to medical devices

181. EN 80001-1:2011 27 May 2024

Safety, effectiveness and security in the

implementation and use of connected medical devices
or connected health software - Part 1: Application of
risk management

182. EN ISO 80369-1:2018 27 May 2024

Small-bore connectors for liquids and gases in

healthcare applications - Part 1: General requirements

183. EN ISO 80369-3:2016 27 May 2024

Small-bore connectors for liquids and gases in

healthcare applications - Part 3: Connectors for enteral
applications

184. EN ISO 80369-5:2016+AC:2017-02 27 May 2024

Small-bore connectors for liquids and gases in

healthcare applications - Part 5: Connectors for limb
cuff inflation applications

185. EN ISO 80369-6:2016 27 May 2014

Small bore connectors for liquids and gases in

healthcare applications - Part 6: Connectors for
neuraxial applications

EN 21 EN
 186. EN ISO 80369-7:2017 27 May 2024

Small-bore connectors for liquids and gases in

healthcare applications - Part 7: Connectors for
intravascular or hypodermic applications

187. EN ISO 80369-20:2015 27 May 2024

Small-bore connectors for liquids and gases in

healthcare applications - Part 20: Common test
methods

188. EN ISO 80601-2-12:2020 27 May 2024

Medical electrical equipment - Part 2-12: Particular

requirements for basic safety and essential
performance of critical care ventilators

189. EN ISO 80601-2-13:2011+A1:2019+A2:2019 27 May 2024

Medical electrical equipment - Part 2-13: Particular

requirements for basic safety and essential
performance of an anaesthetic workstation

190. EN IEC 80601-2-26:2020 27 May 2024

Medical electrical equipment - Part 2-26: Particular

requirements for the basic safety and essential
performance of electroencephalographs

191. EN IEC 80601-2-30:2019 27 May 2024

Medical electrical equipment - Part 2-30: Particular

requirements for the basic safety and essential
performance of automated non-invasive
sphygmomanometers

192. EN IEC 80601-2-35:2019 27 May 2024

Medical electrical equipment - Part 2-35: Particular

requirements for the basic safety and essential
performance of heating devices using blankets, pads
and mattresses and intended for heating in medical use

193. EN IEC 80601-2-49:2019 27 May 2024

Medical electrical equipment - Part 2-49: Particular

requirements for the basic safety and essential
performance of multifunction patient monitoring
equipment

EN 22 EN
 194. EN ISO 80601-2-56:2017+A1:2020 27 May 2024

Medical electrical equipment - Part 2-56: Particular

requirements for basic safety and essential
performance of clinical thermometers for body
temperature measurement

195. EN 80601-2-58:2015+A1:2019 27 May 2024

Medical electrical equipment - Part 2-58: Particular

requirements for the basic safety and essential
performance of lens removal devices and vitrectomy
devices for ophthalmic surgery

196. EN IEC 80601-2-59:2019 27 May 2024

Medical electrical equipment - Part 2-59: Particular

requirements for the basic safety and essential
performance of screening thermographs for human
febrile temperature screening

197. EN IEC 80601-2-60:2020 27 May 2024

Medical electrical equipment - Part 2-60: Particular

requirements for the basic safety and essential
performance of dental equipment

198. EN ISO 80601-2-69:2020 27 May 2024

Medical electrical equipment - Part 2-69: Particular

requirements for basic safety and essential
performance of oxygen concentrator equipment

199. EN IEC 80601-2-71:2018 27 May 2024

Medical electrical equipment - Part 2-71: Particular

requirements for the basic safety and essential
performance of functional near-infrared spectroscopy
(NIRS) equipment

200. EN IEC 80601-2-78:2020 27 May 2024

Medical electrical equipment - Part 2-78: Particular

requirements for basic safety and essential
performance of medical robots for rehabilitation,
assessment, compensation or alleviation

201. EN 82304-1:2017 27 May 2024

Health Software - Part 1: General requirements for

product safety

EN 23 EN
 Table 2: List of new harmonised standards to be drafted and deadlines for their
adoption

Reference information Deadline for the adoption

1. Medical gloves for single use - Part 5: Extractable 27 May 2024

chemical residues (prEN 455-5)

2. Radiation protection - Sealed radioactive sources - 27 May 2024

Leakage test methods (ISO 9978)

3. Biological evaluation of medical devices - Part 23: 27 May 2024

Tests for irritation (ISO 10993-23)

4. Active implantable medical devices - Electromagnetic 27 May 2024

compatibility - EMC test protocols for implantable
cardiac pacemakers, implantable cardioverter
defibrillators and cardiac resynchronization devices
(ISO 14117)

5. Stainless steel steam boilers (prEN 14222) 27 May 2024

6. Implants for surgery - Active implantable medical 27 May 2024

devices - Part 1: General requirements for safety,
marking and for information to be provided by the
manufacturer (ISO 14708-1)

7. Implants for surgery - Active implantable medical 27 May 2024

devices - Part 2: Cardiac pacemakers (ISO 14708-2)

8. Implants for surgery - Active implantable medical 27 May 2024

devices - Part 3: Implantable neurostimulators (ISO
14708-3)

9. Implants for surgery - Active implantable medical 27 May 2024

devices - Part 4: Implantable infusion pumps (ISO
14708-4)

10. Implants for surgery - Active implantable medical 27 May 2024

devices - Part 5: Circulatory support devices (ISO
14708-5)

11. Implants for surgery - Active implantable medical 27 May 2024

devices - Part 6: Particular requirements for active
implantable medical devices intended to treat
tachyarrhythmia (including implantable defibrillators)
(ISO 14708-6)

12. Implants for surgery - Active implantable medical 27 May 2024

devices - Part 7: Particular requirements for cochlear

EN 24 EN
 and auditory brainstem implant systems (ISO 14708-7)

13. Washer-disinfectors - Part 5: Performance 27 May 2024

requirements and test method criteria for
demonstrating cleaning efficacy (ISO 15883-5)

14. Sterilizers for medical purposes - Low temperature 27 May 2024

vapourized hydrogen peroxide sterilizers -
Requirements and testing (prEN 17180)

15. Sterilization of medical devices - Information to be 27 May 2024

provided by the manufacturer for the processing of
resterilizable medical devices (ISO 17664-1)

16. Processing of health care products - Information to be 27 May 2024

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)

17. Assistive products for personal hygiene that support 27 May 2024
users - Requirements and test methods (ISO 17966)

18. Medical devices - Connectors for reservoir delivery 27 May 2024

systems for healthcare applications (ISO 18250)

19. Medical devices - Information to be provided by the 27 May 2024

manufacturer (ISO 20417)

20. Assistive products - General requirements and test 27 May 2024

methods (ISO 21856)

21. Lasers and laser-related equipment - Test methods for 27 May 2024
laser-induced damage threshold - Classification of
medical beam delivery systems (ISO 22248)

22. Cardiac rhythm management devices - Symbols to be 27 May 2024

used with cardiac rhythm management device labels,
and information to be supplied - General requirements
(ISO 27185)

23. Active implantable medical devices - Four-pole 27 May 2024

connector system for implantable cardiac rhythm
management devices - Dimensional and test
requirements (ISO 27186)

24. Medical electrical equipment - Part 4-5: Guidance and 27 May 2024
interpretation - Safety related technical security
specifications for medical devices (IEC TR 60601-4-5)

25. Medical electrical equipment - Part 2-86: Particular 27 May 2024

requirements for the basic safety and essential

EN 25 EN
 performance of electrocardiographs, including
diagnostic equipment, monitoring equipment,
ambulatory equipment, electrodes, cables and
leadwires (IEC 80601-2-86)

26. Medical electrical equipment - Part 2-89: Particular 27 May 2024

requirements for the basic safety and essential
performance of medical beds for children (IEC 80601-
2-89)

27. Health software and health IT systems safety, 27 May 2024

effectiveness and security - Part 5-1: Security -
Activities in the product life cycle (IEC 81001-5-1)

EN 26 EN
 ANNEX II
List of existing standards to be revised and list of new standards to be drafted as
referred to in Article 1(2)

Table 1: List of existing harmonised standards to be revised and deadlines for the
adoption of the revised harmonised standards

Reference information Deadline for the adoption

1. EN 556-1:2001+AC:2006 27 May 2024

Sterilization of medical devices - Requirements for

medical devices to be designated "STERILE" - Part 1:
Requirements for terminally sterilized medical devices

2. EN 556-2:2015 27 May 2024

Sterilization of medical devices - Requirements for

medical devices to be designated ''STERILE" - Part 2:
Requirements for aseptically processed medical
devices

3. EN ISO 7010:2012 27 May 2024

Graphical symbols - Safety colours and safety signs -

Registered safety signs

4. EN ISO 11135:2014+A1:2019 27 May 2024

Sterilization of health-care products - Ethylene oxide -

Requirements for the development, validation and
routine control of a sterilization process for medical
devices

5. EN ISO 11137-1:2015+A2:2019 27 May 2024

Sterilization of health care products - Radiation - Part

1: Requirements for development, validation and
routine control of a sterilization process for medical
devices

6. EN ISO 11137-2:2015 27 May 2024

Sterilization of health care products - Radiation - Part

2: Establishing the sterilization dose

7. EN ISO 11607-1:2020 27 May 2024

Packaging for terminally sterilized medical devices -

Part 1: Requirements for materials, sterile barrier

EN 27 EN
 systems and packaging systems

8. EN ISO 11607-2:2020 27 May 2024

Packaging for terminally sterilized medical devices -

Part 2: Validation requirements for forming, sealing
and assembly processes

9. EN ISO 11737-1:2018 27 May 2024

Sterilization of medical devices - Microbiological

methods - Part 1: Determination of a population of
microorganisms on products

10. EN ISO 11737-2:2020 27 May 2024

Sterilization of medical devices - Microbiological

methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization
process

11. EN ISO 13408-1:2015 27 May 2024

Aseptic processing of health care products - Part 1:
General requirements

12. EN ISO 13408-2:2018 27 May 2024

Aseptic processing of health care products - Part 2:
Filtration

13. EN ISO 13408-3:2011 27 May 2024

Aseptic processing of health care products - Part 3:
Lyophilization

14. EN ISO 13408-4:2011 27 May 2024

Aseptic processing of health care products - Part 4:
Clean-in-place technologies

15. EN ISO 13408-5:2011 27 May 2024

Aseptic processing of health care products - Part 5:
Sterilization in place

16. EN ISO 13408-6:2011+A1:2013 27 May 2024

Aseptic processing of health care products - Part 6:
Isolator systems

17. EN ISO 13408-7:2015 27 May 2024

EN 28 EN
 Aseptic processing of health care products - Part 7:
Alternative processes for medical devices and
combination products

18. EN ISO 13485:2016+AC:2018 27 May 2024

Medical devices - Quality management systems -
Requirements for regulatory purposes

19. EN 13532:2002 27 May 2024

General requirements for in vitro diagnostic medical
devices for self-testing

20. EN 13612:2002+AC:2002 27 May 2024

Performance evaluation of in vitro diagnostic medical
devices

21. EN 13641:2002 27 May 2024

Elimination or reduction of risk of infection related to
in vitro diagnostic reagents

22. EN 13975:2003 27 May 2024

Sampling procedures used for acceptance testing of in
vitro diagnostic medical devices - Statistical aspects

23. EN 14136:2004 27 May 2024

Use of external quality assessment schemes in the
assessment of the performance of in vitro diagnostic
examination procedures

24. EN ISO 14937:2009 27 May 2024

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

25. EN ISO 14971:2019 27 May 2024

Medical devices - Application of risk management to
medical devices

26. EN ISO 15193:2009 27 May 2024

In vitro diagnostic medical devices - Measurement of
quantities in samples of biological origin -
Requirements for content and presentation of reference

EN 29 EN
 measurement procedures

27. EN ISO 15194:2009 27 May 2024

In vitro diagnostic medical devices - Measurement of
quantities in samples of biological origin -
Requirements for certified reference materials and the
content of supporting documentation

28. EN ISO 15197:2015 27 May 2024

In vitro diagnostic test systems - Requirements for
blood-glucose monitoring systems for self-testing in
managing diabetes mellitus

29. EN ISO 15223-1:2016 27 May 2024

Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied
- Part 1: General requirements

30. EN ISO 17511:2003 27 May 2024

In vitro diagnostic medical devices - requirements for

establishing metrological traceability of values
assigned to calibrators, trueness control materials and
human samples

31. EN ISO 17664:2017 27 May 2024

Processing of health care products - Information to be

provided by the medical device manufacturer for the
processing of medical devices

32. EN ISO 17665-1:2006 27 May 2024

Sterilization of health care products - Moist heat - Part
1: Requirements for the development, validation and
routine control of a sterilization process for medical
devices

33. EN ISO 18113-1:2011 27 May 2024

In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 1:
Terms, definitions and general requirements

34. EN ISO 18113-2:2011 27 May 2024

In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 2: In

EN 30 EN
 vitro diagnostic reagents for professional use

35. EN ISO 18113-3:2011 27 May 2024

In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 3: In
vitro diagnostic instruments for professional use

36. EN ISO 18113-4:2011 27 May 2024

In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 4: In
vitro diagnostic reagents for self-testing

37. EN ISO 18113-5:2011 27 May 2024

In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 5: In
vitro diagnostic instruments for self-testing

38. EN ISO 20857:2013 27 May 2024

Sterilization of health care products - Dry heat -
Requirements for the development, validation and
routine control of a sterilization process for medical
devices

39. EN ISO 23640:2015 27 May 2024

In vitro diagnostic medical devices - Evaluation of
stability of in vitro diagnostic reagents

40. EN ISO 25424:2019 27 May 2024

Sterilization of health care products - Low temperature
steam and formaldehyde - Requirements for
development, validation and routine control of a
sterilization process for medical devices

41. EN 61326-1:2013 27 May 2024

Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 1: General
requirements

42. EN 61326-2-6:2013 27 May 2024

Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 2-6:
Particular requirements - In vitro diagnostic (IVD)
medical equipment

EN 31 EN
 43. EN 61010-1:2010+A1:2019+AC:2019 27 May 2024
Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 1:
General requirements

44. EN 61010-2-101:2017 27 May 2024

Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 2-101:
Particular requirements for in vitro diagnostic (IVD)
medical equipment

45. EN 62304:2006+A1:2015
27 May 2024
Medical device software - Software life-cycle
processes

46. EN 62366-1:2015+AC:2015+AC:2016+A1:2020 27 May 2024

Medical devices - Application of usability engineering
to medical devices

Table 2: List of new harmonised standards to be drafted and deadlines for their
adoption

Reference information Deadline for the adoption

1. Sterilization of medical devices - Information to be 27 May 2024

provided by the manufacturer for the processing of
resterilizable medical devices (ISO 17664-1)

2. Processing of health care products - Information to be 27 May 2024

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)

3. In vitro diagnostic medical devices - Clinical 27 May 2024

performance studies using specimens from human
subjects - Good study practice (ISO 20916)

EN 32 EN
 ANNEX III
Requirements for the standards referred to in Article 1
Part A. General requirements
1. Legal requirements to be supported by the harmonised standards
The harmonised standards shall support application of relevant safety and
performance requirements for medical devices and in vitro diagnostic medical
devices for human use and system and process requirements for economic operators
and sponsors of clinical investigations and performance studies set out in Regulations
(EU) 2017/745 and (EU) 2017/746.
The harmonised standards shall provide detailed technical, scientific, processual or
methodological specifications of safety and performance requirements with the
purpose of allowing compliance with relevant requirements of Regulations (EU)
2017/745 and (EU) 2017/746. Where appropriate, the harmonised standards shall
include methods to verify compliance with such specifications.
The structure of a harmonised standard shall be such that a clear distinction can be
made between its clauses and sub-clauses, which are necessary for compliance with
the safety and performance requirements of Regulation (EU) 2017/745 or Regulation
(EU) 2017/746 that the standard aims to cover and those which are not. The
relationship between the clauses and sub-clauses of a harmonised standard and the
requirements of Regulation (EU) 2017/745 or Regulation (EU) 2017/746 shall be
indicated in the Annexes Z to each standard. The relevant requirements of
Regulations (EU) 2017/745 and (EU) 2017/746 shall be taken into account from the
beginning and throughout the process of developing of the standards.
The normative body of a harmonised standard shall not:
(a) make any references to Regulation (EU) 2017/745 or Regulation (EU)
2017/746 or reproduce their requirements;
(b) contradict any definitions set out in Regulations (EU) 2017/745 and (EU)
2017/746 or define any legally relevant terms not defined in those Regulations.
Where a definition in a harmonised standard differs from a definition of the same
term set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746, the
differences shall be indicated in the foreword of that standard and in its Annex Z.
That Annex shall also state that, for the purpose of using the standard in support of
the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746, the
definitions set out in those Regulations prevail.
Each harmonised standard developed on the basis of the standardisation request
referred to in Article 1 shall refer to this Decision.
Each revised harmonised standard shall contain information on significant changes
introduced in that standard.
2. Legal requirements to be covered by an individual harmonised standard
When one of the harmonised standards listed in Annex I or in Annex II does not
cover all relevant requirements applicable to devices or system or process
requirements falling under its scope, or when it covers such requirements only
partially, that standard shall include in its Annex Z information on the relevant
applicable requirements or parts thereof that are not covered by it.

EN 33 EN
 Where appropriate, the harmonised standard shall include information as to whether
a particular requirement is addressed with regard to the design, manufacturing, or
packaging of the device.
3. Reduction of risk
The specifications of harmonised standards concerning the reduction of risk which
may be associated with the device shall take into account the general requirements
laid down in point 2 of Chapter I of Annex I to Regulation (EU) 2017/745 and in
point 2 of Chapter I of Annex I to Regulation (EU) 2017/746 to reduce risks as far as
possible without adversely affecting the benefit-risk ratio.
4. Normative references
Normative references included in a harmonised standard shall be clear and specific
and ensure identification of all specifications covered by the standard. Where a
standard refers to another standard or a clause in that standard, and that standard or
clause contains a further normative reference or references (‘a normative reference
chain’), the whole normative reference chain shall be clear and specific. Normative
reference chains shall be avoided.
Clauses of a standard, which do not provide for technical, scientific or
methodological specifications, but are limited to a normative reference to another
standard or a clause in that standard shall not claim coverage of the legal
requirements that are addressed in the standard normatively referred to.
Standards which do not ensure compliance with legal requirements on their own, but
require application of another standard, shall contain a clear statement to that effect.
They shall not claim coverage of the legal requirements covered by that other
standard.
Standards containing normative references to undated standards shall indicate the
dated version of any such referenced standard.
5. Publicly available description of the meaning of symbols
Where a harmonised standard provides a description of the meaning of symbols to be
used in the information supplied by the manufacturer that description shall be made
publicly available. Public availability of such descriptions shall not affect any
copyright to a harmonised standard or its parts.
Part B. Specific requirements
1. Requirements for all harmonised standards listed in Annexes I and II
The harmonised standards shall ensure safety and effectiveness of devices and a high
level of protection of health and safety of patients, users or others persons. They shall
reflect the generally acknowledged state of the art.
2. Requirements for certain specific standards listed in Annexes I and II
2.1 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization
residuals (EN ISO 10993-7:2008+AC:2009) and Part 17: Establishment of allowable
limits for leachable substances (EN ISO 10993-17:2009)
In the standard EN ISO 10993-7:2008+AC:2009, the method of calculation of residue
limits for ethylene oxide sterilant laid down in point 4.3.1 of that standard shall be
modified in such a way as to take into account also patients with a weight lower/higher

EN 34 EN
 than 70 kg, in particular neonates and other patients with a weight substantially below
the adults’ standard weight of 70 kg.
In the standard EN ISO 10993-17:2009, the method of calculation of concomitant
exposure to ethylene oxide sterilant laid down in points 6.2.2 and 6.3.2 of that
standard shall be modified in such a way as to take into account certain clinical
situations involving use of several medical devices in neonates with a bodyweight
lower than 3,5 kg.
2.2 Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (EN ISO 15223-1:2016)
The existing standard EN ISO 15223-1:2016 shall be modified by the addition of a
symbol which indicates that a device is a medical device or an in vitro diagnostic
medical device to facilitate application of section 23.2(q) of Chapter III of Annex I to
Regulation (EU) 2017/745 or section 20.2(e) of Chapter III of Annex I to Regulation
(EU) 2017/746, as appropriate.
2.3 Sharps injury protection - Requirements and test methods - Sharps protection features
for single-use hypodermic needles, introducers for catheters and needles used for
blood sampling (EN ISO 23908:2013)
The existing standard EN ISO 23908:2013 shall be modified by describing technical
solutions for safety-engineered mechanisms to be applied in design and manufacture
of devices to ensure compliance with points 11.1 and 22.2 of Chapter II of Annex I to
Regulation (EU) 2017/745. The standard shall apply to devices which are intended to
be used for administration and/or extraction of body/blood fluids and/or medicinal
substances.
2.4 Health software - Part 1: General requirements for product safety (EN 82304-1:2017)
The existing standard EN 82304-1:2017 shall be modified by ensuring a clear
separation between products (software) which fall within the scope of Regulation (EU)
2017/745 and those that do not, ensuring that there is no ambiguity on its legal effect
and on which products could claim presumption of conformity on its basis.

EN 35 EN