# Official Journal L 90I/2020

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 090I |
| | |
| English edition | Legislation | Volume 6325 March 2020 |

ISSN 1977-0677

Official Journal

of the European Union

L 090I

English edition

Legislation

Volume 6325 March 2020

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC | 1 |
| | * | Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC | 25 |
| | * | Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council | 33 |

Contents

II   Non-legislative acts

page

DECISIONS

*

Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC

1

*

Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC

25

*

Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council

in vitro

33

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

DECISIONS

| 25.3.2020 | EN | Official Journal of the European Union | LI 90/1 |
| --- | --- | --- | --- |

25.3.2020

EN

Official Journal of the European Union

LI 90/1

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COMMISSION IMPLEMENTING DECISION (EU) 2020/437

of 24 March 2020

on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC

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 Council (1), and in particular Article 10(6) thereof,

Whereas:

| (1) | In accordance with Article 5(1) of Council Directive 93/42/EEC (2), Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of medical devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Union. |
| --- | --- |

(1)

In accordance with Article 5(1) of Council Directive 93/42/EEC (2), Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of medical devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Union.

| (2) | By letters BC/CEN/CENELEC/09/89 of 19 December 1991, M/023 - BC/CEN/03/023/93-08 of 5 August 1993 and M/295 of 9 September 1999, the Commission made requests to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 93/42/EEC. |
| --- | --- |

(2)

By letters BC/CEN/CENELEC/09/89 of 19 December 1991, M/023 - BC/CEN/03/023/93-08 of 5 August 1993 and M/295 of 9 September 1999, the Commission made requests to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 93/42/EEC.

| (3) | On the basis of the request M/295 of 9 September 1999, CEN revised the harmonised standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011, the references of which have been published in the Official Journal of the European Union (3), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019. |
| --- | --- |

(3)

On the basis of the request M/295 of 9 September 1999, CEN revised the harmonised standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011, the references of which have been published in the Official Journal of the European Union (3), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019.

| (4) | The Commission together with CEN has assessed whether standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 comply with the request. |
| --- | --- |

(4)

The Commission together with CEN has assessed whether standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 comply with the request.

| (5) | The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union. |
| --- | --- |

(5)

The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

| (6) | The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 replace the harmonised standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011 respectively. It is therefore necessary to withdraw the references of standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011 from the Official Journal of the European Union. |
| --- | --- |

(6)

The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 replace the harmonised standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011 respectively. It is therefore necessary to withdraw the references of standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011 from the Official Journal of the European Union.

| (7) | On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and EN ISO 13485:2016, the references of which have been published in the Official Journal of the European Union (4), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018. |
| --- | --- |

(7)

On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and EN ISO 13485:2016, the references of which have been published in the Official Journal of the European Union (4), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018.

| (8) | The Commission together with CEN has assessed whether standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 comply with the request. |
| --- | --- |

(8)

The Commission together with CEN has assessed whether standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 comply with the request.

| (9) | The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards and of the corrigendum in the Official Journal of the European Union. |
| --- | --- |

(9)

The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards and of the corrigendum in the Official Journal of the European Union.

| (10) | The harmonised standard EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standard EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the reference of standard EN ISO 13408-2:2011 and of corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European Union. |
| --- | --- |

(10)

The harmonised standard EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standard EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the reference of standard EN ISO 13408-2:2011 and of corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European Union.

| (11) | On the basis of the request M/023 - BC/CEN/03/023/93-08 of 5 August 1993, CEN revised the harmonised standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009, the references of which have been published in the Official Journal of the European Union (5), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017. |
| --- | --- |

(11)

On the basis of the request M/023 - BC/CEN/03/023/93-08 of 5 August 1993, CEN revised the harmonised standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009, the references of which have been published in the Official Journal of the European Union (5), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017.

| (12) | The Commission together with CEN has assessed whether standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 comply with the request. |
| --- | --- |

(12)

The Commission together with CEN has assessed whether standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 comply with the request.

| (13) | The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union. |
| --- | --- |

(13)

The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

| (14) | The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 replace the harmonised standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009 respectively. It is therefore necessary to withdraw the references of standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009 from the Official Journal of the European Union. |
| --- | --- |

(14)

The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 replace the harmonised standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009 respectively. It is therefore necessary to withdraw the references of standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009 from the Official Journal of the European Union.

| (15) | On the basis of the request M/295 of 9 September 1999, CEN drafted the new harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019 and EN ISO 81060-2:2019. The Commission together with CEN has assessed whether those standards comply with the request. |
| --- | --- |

(15)

On the basis of the request M/295 of 9 September 1999, CEN drafted the new harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019 and EN ISO 81060-2:2019. The Commission together with CEN has assessed whether those standards comply with the request.

| (16) | The harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019 and EN ISO 81060-2:2019 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union. |
| --- | --- |

(16)

The harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019 and EN ISO 81060-2:2019 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

| (17) | On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN drafted the new harmonised standard EN ISO 25424:2019. The Commission together with CEN has assessed whether that standard complies with the request. |
| --- | --- |

(17)

On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN drafted the new harmonised standard EN ISO 25424:2019. The Commission together with CEN has assessed whether that standard complies with the request.

| (18) | The harmonised standard EN ISO 25424:2019 satisfies the requirements, which it aims to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union. |
| --- | --- |

(18)

The harmonised standard EN ISO 25424:2019 satisfies the requirements, which it aims to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union.

| (19) | In order to give manufacturers sufficient time to adapt their products to the revised specifications in standards and the corrigendum published by this Decision, it is necessary to defer the withdrawal of the reference of the standards and the corrigendum that are replaced. |
| --- | --- |

(19)

In order to give manufacturers sufficient time to adapt their products to the revised specifications in standards and the corrigendum published by this Decision, it is necessary to defer the withdrawal of the reference of the standards and the corrigendum that are replaced.

| (20) | In the interests of clarity and legal certainty, a complete list of references of harmonised standards drafted in support of Directive 93/42/EEC and satisfying the essential requirements they aim to cover should be published in one act. The other references of standards published in the Commission communication 2017/C 389/03 (6) should therefore also be included in this Decision. That Communication should therefore be repealed from the date of entry into force of this Decision. However, it should continue to apply in respect of the references of the standards that are withdrawn by this Decision, given that it is necessary to defer withdrawal of those references. |
| --- | --- |

(20)

In the interests of clarity and legal certainty, a complete list of references of harmonised standards drafted in support of Directive 93/42/EEC and satisfying the essential requirements they aim to cover should be published in one act. The other references of standards published in the Commission communication 2017/C 389/03 (6) should therefore also be included in this Decision. That Communication should therefore be repealed from the date of entry into force of this Decision. However, it should continue to apply in respect of the references of the standards that are withdrawn by this Decision, given that it is necessary to defer withdrawal of those references.

| (21) | In accordance with the second subparagraph of Article 120(2) of Regulation (EU) 2017/745 of the European Parliament and of the Council (7), certificates issued by notified bodies in accordance with Directive 93/42/EEC from 25 May 2017 are to remain valid until the end of the period indicated on the certificate, which is not to exceed five years from its issuance. They are to however become void at the latest on 27 May 2024. In accordance with the first subparagraph of Article 120(3) of Regulation (EU) 2017/745 a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 93/42/EEC and that is valid by virtue of Article 120(2), may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with Directive 93/42/EEC, and provided there are no significant changes in the design and intended purpose. This Decision should therefore apply only until 26 May 2024. |
| --- | --- |

(21)

In accordance with the second subparagraph of Article 120(2) of Regulation (EU) 2017/745 of the European Parliament and of the Council (7), certificates issued by notified bodies in accordance with Directive 93/42/EEC from 25 May 2017 are to remain valid until the end of the period indicated on the certificate, which is not to exceed five years from its issuance. They are to however become void at the latest on 27 May 2024. In accordance with the first subparagraph of Article 120(3) of Regulation (EU) 2017/745 a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 93/42/EEC and that is valid by virtue of Article 120(2), may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with Directive 93/42/EEC, and provided there are no significant changes in the design and intended purpose. This Decision should therefore apply only until 26 May 2024.

| (22) | The requirements for medical devices laid down in Directive 93/42/EEC are different from those laid down in Regulation (EU) 2017/745. The standards drafted in support of Directive 93/42/EEC should therefore not be used to demonstrate conformity with requirements of Regulation (EU) 2017/745. |
| --- | --- |

(22)

The requirements for medical devices laid down in Directive 93/42/EEC are different from those laid down in Regulation (EU) 2017/745. The standards drafted in support of Directive 93/42/EEC should therefore not be used to demonstrate conformity with requirements of Regulation (EU) 2017/745.

| (23) | Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication, |
| --- | --- |

(23)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication,

HAS ADOPTED THIS DECISION:

Article 1

The references of the harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annex I to this Decision are hereby published in the Official Journal of the European Union.

Article 2

Commission communication 2017/C 389/03 is repealed. It shall continue to apply until 30 September 2021 in respect of the references of the standards listed in Annex II to this Decision.

Article 3

The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745.

Article 4

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply until 26 May 2024.

Done at Brussels, 24 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 316, 14.11.2012, p. 12.

1

(2)  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).

2

(3)  
  OJ C 389, 17.11.2017, p. 29.

3

(4)  
  OJ C 389, 17.11.2017, p. 29.

4

(5)  
  OJ C 389, 17.11.2017, p. 29.

5

(6)  Commission communication in the framework of the implementation of Council Directive 93/42/EEC concerning medical devices (2017/C 389/03) (OJ C 389, 17.11.2017, p. 29).

6

(7)  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).

7

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ANNEX I

| No | Reference of the standard |
| --- | --- |
| 1. | EN 285:2006+A2:2009
  Sterilization - Steam sterilizers - Large sterilizers |
| 2. | EN 455-1:2000
  Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
| 3. | EN 455-2:2009+A2:2013
  Medical gloves for single use - Part 2: Requirements and testing for physical properties |
| 4. | EN 455-3:2006
  Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| 5. | EN 455-4:2009
  Medical gloves for single use - Part 4: Requirements and testing for shelf life determination |
| 6. | EN 556-1:2001
  Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  EN 556-1:2001/AC:2006 |
| 7. | EN 556-2:2015
  Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
| 8. | EN 794-3:1998+A2:2009
  Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
| 9. | EN 1041:2008
  Information supplied by the manufacturer of medical devices |
| 10. | EN 1060-3:1997+A2:2009
  Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
| 11. | EN 1060-4:2004
  Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| 12. | EN ISO 1135-4:2011
  Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010) |
| 13. | EN 1282-2:2005+A1:2009
  Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
| 14. | EN 1422:1997+A1:2009
  Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| 15. | EN 1618:1997
  Catheters other than intravascular catheters - Test methods for common properties |
| 16. | EN 1639:2009
  Dentistry - Medical devices for dentistry - Instruments |
| 17. | EN 1640:2009
  Dentistry - Medical devices for dentistry - Equipment |
| 18. | EN 1641:2009
  Dentistry - Medical devices for dentistry - Materials |
| 19. | EN 1642:2011
  Dentistry - Medical devices for dentistry - Dental implants |
| 20. | EN 1707:1996
  Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| 21. | EN 1782:1998+A1:2009
  Tracheal tubes and connectors |
| 22. | EN 1789:2007+A1:2010
  Medical vehicles and their equipment - Road ambulances |
| 23. | EN 1820:2005+A1:2009
  Anaesthetic reservoir bags (ISO 5362:2000, modified) |
| 24. | EN 1865-1:2010+A1:2015
  Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
| 25. | EN 1865-2:2010+A1:2015
  Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| 26. | EN 1865-3:2012
  Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| 27. | EN 1865-4:2012
  Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
| 28. | EN 1865-5:2012
  Patient handling equipment used in road ambulances - Part 5: Stretcher support |
| 29. | EN 1985:1998
  Walking aids - General requirements and test methods
  Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
| 30. | EN ISO 3826-2:2008
  Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
| 31. | EN ISO 3826-3:2007
  Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826- 3:2006) |
| 32. | EN ISO 3826-4:2015
  Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
| 33. | EN ISO 4074:2002
  Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) |
| 34. | EN ISO 4135:2001
  Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
| 35. | EN ISO 5359:2008
  Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
  EN ISO 5359:2008/A1:2011 |
| 36. | EN ISO 5360:2009
  Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006) |
| 37. | EN ISO 5366-1:2009
  Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) |
| 38. | EN ISO 5840:2009
  Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
| 39. | EN ISO 7197:2009
  Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| 40. | EN ISO 7376:2009
  Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) |
| 41. | EN ISO 7396-1:2007
  Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
  EN ISO 7396-1:2007/A1:2010
  EN ISO 7396-1:2007/A2:2010 |
| 42. | EN ISO 7396-2:2007
  Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
| 43. | EN ISO 7886-3:2009
  Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) |
| 44. | EN ISO 7886-4:2009
  Sterile hypodermic syringes for single use - Part 4: Syringes with reuse prevention feature (ISO 7886-4:2006) |
| 45. | EN ISO 8185:2009
  Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| 46. | EN ISO 8359:2009
  Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
  EN ISO 8359:2009/A1:2012 |
| 47. | EN ISO 8835-2:2009
  Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835- 2:2007) |
| 48. | EN ISO 8835-3:2009
  Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)
  EN ISO 8835-3:2009/A1:2010 |
| 49. | EN ISO 8835-4:2009
  Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835- 4:2004) |
| 50. | EN ISO 8835-5:2009
  Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
| 51. | EN ISO 9170-1:2008
  Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) |
| 52. | EN ISO 9170-2:2008
  Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
| 53. | EN ISO 9360-1:2009
  Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
| 54. | EN ISO 9360-2:2009
  Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) |
| 55. | EN ISO 9713:2009
  Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) |
| 56. | EN ISO 10079-1:2009
  Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) |
| 57. | EN ISO 10079-2:2009
  Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
| 58. | EN ISO 10079-3:2009
  Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
| 59. | EN ISO 10328:2016
  Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016) |
| 60. | EN ISO 10524-1:2006
  Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524- 1:2006) |
| 61. | EN ISO 10524-2:2006
  Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
| 62. | EN ISO 10524-3:2006
  Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) |
| 63. | EN ISO 10524-4:2008
  Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524- 4:2008) |
| 64. | EN ISO 10535:2006
  Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)
  Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
| 65. | EN ISO 10555-1:2009
  Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004) |
| 66. | EN ISO 10651-2:2009
  Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651- 2:2004) |
| 67. | EN ISO 10651-4:2009
  Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
| 68. | EN ISO 10651-6:2009
  Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
| 69. | EN ISO 10993-1:2009
  Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
  EN ISO 10993-1:2009/AC:2010 |
| 70. | EN ISO 10993-3:2014
  Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
| 71. | EN ISO 10993-4:2009
  Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
| 72. | EN ISO 10993-5:2009
  Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| 73. | EN ISO 10993-6:2009
  Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
| 74. | EN ISO 10993-7:2008
  Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
  EN ISO 10993-7:2008/AC:2009 |
| 75. | EN ISO 10993-9:2009
  Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
| 76. | EN ISO 10993-11:2018
  Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017) |
| 77. | EN ISO 10993-12:2012
  Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| 78. | EN ISO 10993-13:2010
  Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| 79. | EN ISO 10993-14:2009
  Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| 80. | EN ISO 10993-15:2009
  Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
| 81. | EN ISO 10993-16:2010
  Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
| 82. | EN ISO 10993-17:2009
  Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| 83. | EN ISO 10993-18:2009
  Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| 84. | EN ISO 11135-1:2007
  Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
| 85. | 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 (ISO 11137-1:2006, including Amd 1:2013)
  EN ISO 11137-1:2015/A2:2019 |
| 86. | EN ISO 11137-2:2015
  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| 87. | EN ISO 11138-2:2009
  Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
| 88. | EN ISO 11138-3:2009
  Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
| 89. | EN ISO 11140-1:2009
  Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) |
| 90. | EN ISO 11140-3:2009
  Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) |
| 91. | EN ISO 11197:2009
  Medical supply units (ISO 11197:2004) |
| 92. | EN ISO 11607-1:2009
  Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
| 93. | EN ISO 11607-2:2006
  Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) |
| 94. | EN ISO 11608-7:2017
  Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
| 95. | EN ISO 11737-1:2006
  Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
  EN ISO 11737-1:2006/AC:2009 |
| 96. | 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 (ISO 11737-2:2009) |
| 97. | EN ISO 11810-1:2009
  Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005) |
| 98. | EN ISO 11810-2:2009
  Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007) |
| 99. | EN ISO 11979-8:2009
  Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979- 8:2006) |
| 100. | EN ISO 11990:2018
  Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018) |
| 101. | EN 12006-2:1998+A1:2009
  Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
| 102. | EN 12006-3:1998+A1:2009
  Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
| 103. | EN 12183:2009
  Manual wheelchairs - Requirements and test methods |
| 104. | EN 12184:2009
  Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| 105. | EN 12342:1998+A1:2009
  Breathing tubes intended for use with anaesthetic apparatus and ventilators |
| 106. | EN 12470-1:2000+A1:2009
  Clinical thermometers - Part 1: Metallic liquid- in-glass thermometers with maximum device |
| 107. | EN 12470-2:2000+A1:2009
  Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
| 108. | EN 12470-3:2000+A1:2009
  Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
| 109. | EN 12470-4:2000+A1:2009
  Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
| 110. | EN 12470-5:2003
  Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)
  Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
| 111. | EN ISO 12870:2009
  Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004) |
| 112. | EN 13060:2014
  Small steam sterilizers |
| 113. | EN ISO 13408-1:2015
  Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| 114. | EN ISO 13408-2:2018
  Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| 115. | EN ISO 13408-3:2011
  Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) |
| 116. | EN ISO 13408-4:2011
  Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
| 117. | EN ISO 13408-5:2011
  Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| 118. | EN ISO 13408-6:2011
  Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) |
| 119. | EN ISO 13408-7:2015
  Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
| 120. | EN ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  EN ISO 13485:2016/AC:2018 |
| 121. | EN 13544-1:2007+A1:2009
  Respiratory therapy equipment - Part 1: Nebulizing systems and their component |
| 122. | EN 13544-2:2002+A1:2009
  Respiratory therapy equipment - Part 2: Tubing and connectors |
| 123. | EN 13544-3:2001+A1:2009
  Respiratory therapy equipment - Part 3: Air entrainment devices |
| 124. | EN 13624:2003
  Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1) |
| 125. | EN 13718-1:2008
  Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| 126. | EN 13718-2:2015
  Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| 127. | EN 13726-1:2002
  Test methods for primary wound dressings - Part 1: Aspects of absorbency
  EN 13726-1:2002/AC:2003 |
| 128. | EN 13726-2:2002
  Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings |
| 129. | EN 13727:2012
  Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1) |
| 130. | EN 13795-1:2019
  Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns |
| 131. | EN 13795-2:2019
  Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits |
| 132. | EN 13867:2002+A1:2009
  Concentrates for haemodialysis and related therapies |
| 133. | EN 13976-1:2011
  Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| 134. | EN 13976-2:2018
  Rescue systems - Transportation of incubators - Part 2: System requirements |
| 135. | EN 14079:2003
  Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
| 136. | EN 14139:2010
  Ophthalmic optics - Specifications for ready-to- wear spectacles |
| 137. | EN ISO 14155:2011
  Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  EN ISO 14155:2011/AC:2011 |
| 138. | EN 14180:2003+A2:2009
  Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| 139. | EN 14348:2005
  Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1) |
| 140. | EN ISO 14408:2009
  Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005) |
| 141. | EN 14561:2006
  Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) |
| 142. | EN 14562:2006
  Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) |
| 143. | EN 14563:2008
  Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2) |
| 144. | EN ISO 14602:2011
  Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) |
| 145. | EN ISO 14607:2009
  Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007) |
| 146. | EN ISO 14630:2009
  Non-active surgical implants - General requirements (ISO 14630:2008) |
| 147. | EN 14683:2019+AC:2019
  Medical face masks - Requirements and test methods |
| 148. | EN ISO 14889:2009
  Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
| 149. | EN 14931:2006
  Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
| 150. | 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 (ISO 14937:2009) |
| 151. | EN ISO 14971:2012
  Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| 152. | EN ISO 15001:2011
  Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| 153. | EN ISO 15002:2008
  Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| 154. | EN ISO 15004-1:2009
  Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
| 155. | 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 (ISO 15223-1:2016, Corrected version 2017-03) |
| 156. | EN ISO 15747:2019
  Plastic containers for intravenous injections (ISO 15747:2018) |
| 157. | EN ISO 15798:2010
  Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010) |
| 158. | EN ISO 15883-1:2009
  Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
| 159. | EN ISO 15883-2:2009
  Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) |
| 160. | EN ISO 15883-3:2009
  Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) |
| 161. | EN ISO 15883-4:2018
  Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018) |
| 162. | EN 15986:2011
  Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalate |
| 163. | EN ISO 16061:2009
  Instrumentation for use in association with non- active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03- 15) |
| 164. | EN ISO 16201:2006
  Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006) |
| 165. | EN ISO 17510-1:2009
  Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| 166. | EN ISO 17510-2:2009
  Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) |
| 167. | EN ISO 17664:2017
  Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) |
| 168. | 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 (ISO 17665-1:2006) |
| 169. | EN ISO 18777:2009
  Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) |
| 170. | EN ISO 18778:2009
  Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| 171. | EN ISO 18779:2005
  Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
| 172. | EN ISO 19054:2006
  Rail systems for supporting medical equipment (ISO 19054:2005) |
| 173. | EN 20594-1:1993
  Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
  EN 20594-1:1993/A1:1997
  EN 20594-1:1993/AC:1996 |
| 174. | EN ISO 21534:2009
  Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) |
| 175. | EN ISO 21535:2009
  Non-active surgical implants - Joint replacement implants - Specific requirements for hip- joint replacement implants (ISO 21535:2007) |
| 176. | EN ISO 21536:2009
  Non-active surgical implants - Joint replacement implants - Specific requirements for knee- joint replacement implants (ISO 21536:2007) |
| 177. | EN ISO 21649:2009
  Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| 178. | EN ISO 21969:2009
  High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| 179. | EN ISO 21987:2017
  Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017) |
| 180. | EN ISO 22442-1:2007
  Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007) |
| 181. | EN ISO 22442-2:2007
  Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) |
| 182. | 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 (TSE) agents (ISO 22442-3:2007) |
| 183. | EN ISO 22523:2006
  External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
  Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
| 184. | EN ISO 22675:2016
  Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) |
| 185. | EN ISO 23328-1:2008
  Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328- 1:2003) |
| 186. | EN ISO 23328-2:2009
  Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002) |
| 187. | EN ISO 23747:2009
  Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) |
| 188. | EN ISO 25424:2019
  Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
| 189. | EN ISO 25539-1:2009
  Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
  EN ISO 25539-1:2009/AC:2011 |
| 190. | EN ISO 25539-2:2009
  Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539- 2:2008)
  EN ISO 25539-2:2009/AC:2011 |
| 191. | EN ISO 26782:2009
  Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
  EN ISO 26782:2009/AC:2009 |
| 192. | EN 27740:1992
  Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
  EN 27740:1992/A1:1997
  EN 27740:1992/AC:1996 |
| 193. | EN 60118-13:2005
  Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 194. | EN 60522:1999
  Determination of the permanent filtration of X- ray tube assemblies (IEC 60522:1999)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 195. | EN 60580:2000
  Medical electrical equipment - Dose area product meters (IEC 60580:2000)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 196. | EN 60601-1:2006
  Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
  EN 60601-1:2006/AC:2010
  EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012) |
| 197. | EN 60601-1-1:2001
  Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 198. | EN 60601-1-2:2015
  Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014) |
| 199. | EN 60601-1-3:2008
  Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008)
  EN 60601-1-3:2008/AC:2010
  EN 60601-1-3:2008/A11:2016
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 200. | EN 60601-1-4:1996
  Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996)
  EN 60601-1-4:1996/A1:1999 (IEC 60601-1-4:1996/A1:1999)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 201. | EN 60601-1-6:2010
  Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 202. | EN 60601-1-8:2007
  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 (IEC 60601-1-8:2006)
  EN 60601-1-8:2007/AC:2010
  EN 60601-1-8:2007/A11:2017
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 203. | EN 60601-1-10:2008
  Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 204. | EN 60601-1-11:2010
  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 (IEC 60601-1-11:2010)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 205. | EN 60601-2-1:1998
  Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998)
  EN 60601-2-1:1998/A1:2002 (IEC 60601-2-1:1998/A1:2002)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 206. | EN 60601-2-2:2009
  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 (IEC 60601-2-2:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 207. | EN 60601-2-3:1993
  Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991)
  EN 60601-2-3:1993/A1:1998 (IEC 60601-2-3:1991/A1:1998)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 208. | EN 60601-2-4:2003
  Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 209. | EN 60601-2-5:2000
  Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 210. | EN 60601-2-8:1997
  Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987)
  EN 60601-2-8:1997/A1:1997 (IEC 60601-2-8:1987/A1:1997)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 211. | EN 60601-2-10:2000
  Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987)
  EN 60601-2-10:2000/A1:2001 (IEC 60601-2-10:1987/A1:2001)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 212. | EN 60601-2-11:1997
  Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)
  EN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 213. | EN 60601-2-12:2006
  Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators (IEC 60601-2-12:2001)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 214. | EN 60601-2-13:2006
  Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (IEC 60601-2-13:2003)
  EN 60601-2-13:2006/A1:2007 (IEC 60601-2-13:2003/A1:2006)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 215. | EN 60601-2-16:1998
  Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998)
  EN 60601-2-16:1998/AC:1999
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 216. | EN 60601-2-17:2004
  Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 217. | EN 60601-2-18:1996
  Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)
  EN 60601-2-18:1996/A1:2000 (IEC 60601-2-18:1996/A1:2000)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 218. | EN 60601-2-19:2009
  Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 219. | EN 60601-2-20:2009
  Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 220. | EN 60601-2-21:2009
  Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 221. | EN 60601-2-22:1996
  Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995)
  Notice: This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 222. | EN 60601-2-23:2000
  Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1999)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 223. | EN 60601-2-24:1998
  Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 224. | EN 60601-2-25:1995
  Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993)
  EN 60601-2-25:1995/A1:1999 (IEC 60601-2-25:1993/A1:1999)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 225. | EN 60601-2-26:2003
  Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 226. | EN 60601-2-27:2006
  Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005)
  EN 60601-2-27:2006/AC:2006
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 227. | EN 60601-2-28:2010
  Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2010)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 228. | EN 60601-2-29:2008
  Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 229. | EN 60601-2-30:2000
  Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non- invasive blood pressure monitoring equipment (IEC 60601-2-30:1999)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 230. | EN 60601-2-33:2010
  Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
  EN 60601-2-33:2010/A1:2015 (IEC 60601-2-33:2010/A1:2013)
  EN 60601-2-33:2010/A2:2015 (IEC 60601-2-33:2010/A2:2015)
  EN 60601-2-33:2010/AC:2016-03
  EN 60601-2-33:2010/A12:2016 |
| 231. | EN 60601-2-34:2000
  Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 232. | EN 60601-2-36:1997
  Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 233. | EN 60601-2-37:2008
  Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 234. | EN 60601-2-39:2008
  Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 235. | EN 60601-2-40:1998
  Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 236. | EN 60601-2-41:2009
  Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 237. | EN 60601-2-43:2010
  Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 238. | EN 60601-2-44:2009
  Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 239. | EN 60601-2-45:2001
  Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 240. | EN 60601-2-46:1998
  Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 241. | EN 60601-2-47:2001
  Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 242. | EN 60601-2-49:2001
  Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 243. | EN 60601-2-50:2009
  Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 244. | EN 60601-2-51:2003
  Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 245. | EN 60601-2-52:2010
  Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)
  EN 60601-2-52:2010/AC:2011
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 246. | EN 60601-2-54:2009
  Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 247. | EN 60627:2001
  Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)
  EN 60627:2001/AC:2002
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 248. | EN 60645-1:2001
  Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers (IEC 60645-1:2001)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 249. | EN 60645-2:1997
  Audiometers - Part 2: Equipment for speech audiometry (IEC 60645-2:1993)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 250. | EN 60645-3:2007
  Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration (IEC 60645-3:2007)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 251. | EN 60645-4:1995
  Audiometers - Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 252. | EN 61217:2012
  Radiotherapy equipment - Coordinates, movements and scales (IEC 61217:2011) |
| 253. | EN 61676:2002
  Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002)
  EN 61676:2002/A1:2009 (IEC 61676:2002/A1:2008)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 254. | EN 62083:2009
  Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 255. | EN 62220-1:2004
  Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency (IEC 62220-1:2003)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 256. | EN 62220-1-2:2007
  Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography (IEC 62220-1-2:2007)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 257. | EN 62220-1-3:2008
  Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging (IEC 62220-1-3:2008)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 258. | EN 62304:2006
  Medical device software - Software life-cycle processes (IEC 62304:2006)
  EN 62304:2006/AC:2008
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 259. | EN 62366:2008
  Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 260. | EN 80601-2-35:2009
  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 (IEC 80601-2-35:2009)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 261. | EN 80601-2-58:2009
  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 (IEC 80601-2-58:2008)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 262. | EN 80601-2-59:2009
  Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 80601-2-59:2008)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 263. | EN ISO 81060-1:2012
  Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
| 264. | EN ISO 81060-2:2019
  Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018) |

No

Reference of the standard

1.

EN 285:2006+A2:2009

Sterilization - Steam sterilizers - Large sterilizers

2.

EN 455-1:2000

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

3.

EN 455-2:2009+A2:2013

Medical gloves for single use - Part 2: Requirements and testing for physical properties

4.

EN 455-3:2006

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

5.

EN 455-4:2009

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

6.

EN 556-1:2001

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

EN 556-1:2001/AC:2006

7.

EN 556-2:2015

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

8.

EN 794-3:1998+A2:2009

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

9.

EN 1041:2008

Information supplied by the manufacturer of medical devices

10.

EN 1060-3:1997+A2:2009

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

11.

EN 1060-4:2004

Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

12.

EN ISO 1135-4:2011

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)

13.

EN 1282-2:2005+A1:2009

Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

14.

EN 1422:1997+A1:2009

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

15.

EN 1618:1997

Catheters other than intravascular catheters - Test methods for common properties

16.

EN 1639:2009

Dentistry - Medical devices for dentistry - Instruments

17.

EN 1640:2009

Dentistry - Medical devices for dentistry - Equipment

18.

EN 1641:2009

Dentistry - Medical devices for dentistry - Materials

19.

EN 1642:2011

Dentistry - Medical devices for dentistry - Dental implants

20.

EN 1707:1996

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

21.

EN 1782:1998+A1:2009

Tracheal tubes and connectors

22.

EN 1789:2007+A1:2010

Medical vehicles and their equipment - Road ambulances

23.

EN 1820:2005+A1:2009

Anaesthetic reservoir bags (ISO 5362:2000, modified)

24.

EN 1865-1:2010+A1:2015

Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment

25.

EN 1865-2:2010+A1:2015

Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher

26.

EN 1865-3:2012

Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

27.

EN 1865-4:2012

Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair

28.

EN 1865-5:2012

Patient handling equipment used in road ambulances - Part 5: Stretcher support

29.

EN 1985:1998

Walking aids - General requirements and test methods

Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.

30.

EN ISO 3826-2:2008

Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)

31.

EN ISO 3826-3:2007

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826- 3:2006)

32.

EN ISO 3826-4:2015

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

33.

EN ISO 4074:2002

Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)

34.

EN ISO 4135:2001

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)

35.

EN ISO 5359:2008

Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

EN ISO 5359:2008/A1:2011

36.

EN ISO 5360:2009

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

37.

EN ISO 5366-1:2009

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

38.

EN ISO 5840:2009

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

39.

EN ISO 7197:2009

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

40.

EN ISO 7376:2009

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

41.

EN ISO 7396-1:2007

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

EN ISO 7396-1:2007/A1:2010

EN ISO 7396-1:2007/A2:2010

42.

EN ISO 7396-2:2007

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

43.

EN ISO 7886-3:2009

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

44.

EN ISO 7886-4:2009

Sterile hypodermic syringes for single use - Part 4: Syringes with reuse prevention feature (ISO 7886-4:2006)

45.

EN ISO 8185:2009

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

46.

EN ISO 8359:2009

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

EN ISO 8359:2009/A1:2012

47.

EN ISO 8835-2:2009

Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835- 2:2007)

48.

EN ISO 8835-3:2009

Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

EN ISO 8835-3:2009/A1:2010

49.

EN ISO 8835-4:2009

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835- 4:2004)

50.

EN ISO 8835-5:2009

Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

51.

EN ISO 9170-1:2008

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)

52.

EN ISO 9170-2:2008

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

53.

EN ISO 9360-1:2009

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

54.

EN ISO 9360-2:2009

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)

55.

EN ISO 9713:2009

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

56.

EN ISO 10079-1:2009

Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

57.

EN ISO 10079-2:2009

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

58.

EN ISO 10079-3:2009

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

59.

EN ISO 10328:2016

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)

60.

EN ISO 10524-1:2006

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524- 1:2006)

61.

EN ISO 10524-2:2006

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

62.

EN ISO 10524-3:2006

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

63.

EN ISO 10524-4:2008

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524- 4:2008)

64.

EN ISO 10535:2006

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.

65.

EN ISO 10555-1:2009

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

66.

EN ISO 10651-2:2009

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651- 2:2004)

67.

EN ISO 10651-4:2009

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

68.

EN ISO 10651-6:2009

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

69.

EN ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-1:2009/AC:2010

70.

EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

71.

EN ISO 10993-4:2009

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

72.

EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

73.

EN ISO 10993-6:2009

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

74.

EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008/AC:2009

75.

EN ISO 10993-9:2009

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

76.

EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

77.

EN ISO 10993-12:2012

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

78.

EN ISO 10993-13:2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

79.

EN ISO 10993-14:2009

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

80.

EN ISO 10993-15:2009

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

81.

EN ISO 10993-16:2010

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

82.

EN ISO 10993-17:2009

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

83.

EN ISO 10993-18:2009

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

84.

EN ISO 11135-1:2007

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

85.

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 (ISO 11137-1:2006, including Amd 1:2013)

EN ISO 11137-1:2015/A2:2019

86.

EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

87.

EN ISO 11138-2:2009

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

88.

EN ISO 11138-3:2009

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

89.

EN ISO 11140-1:2009

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

90.

EN ISO 11140-3:2009

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

91.

EN ISO 11197:2009

Medical supply units (ISO 11197:2004)

92.

EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

93.

EN ISO 11607-2:2006

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

94.

EN ISO 11608-7:2017

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)

95.

EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

EN ISO 11737-1:2006/AC:2009

96.

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 (ISO 11737-2:2009)

97.

EN ISO 11810-1:2009

Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)

98.

EN ISO 11810-2:2009

Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)

99.

EN ISO 11979-8:2009

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979- 8:2006)

100.

EN ISO 11990:2018

Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)

101.

EN 12006-2:1998+A1:2009

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

102.

EN 12006-3:1998+A1:2009

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

103.

EN 12183:2009

Manual wheelchairs - Requirements and test methods

104.

EN 12184:2009

Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods

105.

EN 12342:1998+A1:2009

Breathing tubes intended for use with anaesthetic apparatus and ventilators

106.

EN 12470-1:2000+A1:2009

Clinical thermometers - Part 1: Metallic liquid- in-glass thermometers with maximum device

107.

EN 12470-2:2000+A1:2009

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

108.

EN 12470-3:2000+A1:2009

Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

109.

EN 12470-4:2000+A1:2009

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

110.

EN 12470-5:2003

Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)

Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.

111.

EN ISO 12870:2009

Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)

112.

EN 13060:2014

Small steam sterilizers

113.

EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

114.

EN ISO 13408-2:2018

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

115.

EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

116.

EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

117.

EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

118.

EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

119.

EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

120.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2018

121.

EN 13544-1:2007+A1:2009

Respiratory therapy equipment - Part 1: Nebulizing systems and their component

122.

EN 13544-2:2002+A1:2009

Respiratory therapy equipment - Part 2: Tubing and connectors

123.

EN 13544-3:2001+A1:2009

Respiratory therapy equipment - Part 3: Air entrainment devices

124.

EN 13624:2003

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

125.

EN 13718-1:2008

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

126.

EN 13718-2:2015

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

127.

EN 13726-1:2002

Test methods for primary wound dressings - Part 1: Aspects of absorbency

EN 13726-1:2002/AC:2003

128.

EN 13726-2:2002

Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings

129.

EN 13727:2012

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)

130.

EN 13795-1:2019

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

131.

EN 13795-2:2019

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

132.

EN 13867:2002+A1:2009

Concentrates for haemodialysis and related therapies

133.

EN 13976-1:2011

Rescue systems - Transportation of incubators - Part 1: Interface conditions

134.

EN 13976-2:2018

Rescue systems - Transportation of incubators - Part 2: System requirements

135.

EN 14079:2003

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

136.

EN 14139:2010

Ophthalmic optics - Specifications for ready-to- wear spectacles

137.

EN ISO 14155:2011

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

EN ISO 14155:2011/AC:2011

138.

EN 14180:2003+A2:2009

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

139.

EN 14348:2005

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)

140.

EN ISO 14408:2009

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)

141.

EN 14561:2006

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

142.

EN 14562:2006

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

143.

EN 14563:2008

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)

144.

EN ISO 14602:2011

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

145.

EN ISO 14607:2009

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

146.

EN ISO 14630:2009

Non-active surgical implants - General requirements (ISO 14630:2008)

147.

EN 14683:2019+AC:2019

Medical face masks - Requirements and test methods

148.

EN ISO 14889:2009

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)

149.

EN 14931:2006

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing

150.

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 (ISO 14937:2009)

151.

EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

152.

EN ISO 15001:2011

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

153.

EN ISO 15002:2008

Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)

154.

EN ISO 15004-1:2009

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

155.

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 (ISO 15223-1:2016, Corrected version 2017-03)

156.

EN ISO 15747:2019

Plastic containers for intravenous injections (ISO 15747:2018)

157.

EN ISO 15798:2010

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

158.

EN ISO 15883-1:2009

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

159.

EN ISO 15883-2:2009

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)

160.

EN ISO 15883-3:2009

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

161.

EN ISO 15883-4:2018

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)

162.

EN 15986:2011

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalate

163.

EN ISO 16061:2009

Instrumentation for use in association with non- active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03- 15)

164.

EN ISO 16201:2006

Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)

165.

EN ISO 17510-1:2009

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

166.

EN ISO 17510-2:2009

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

167.

EN ISO 17664:2017

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

168.

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 (ISO 17665-1:2006)

169.

EN ISO 18777:2009

Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)

170.

EN ISO 18778:2009

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

171.

EN ISO 18779:2005

Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)

172.

EN ISO 19054:2006

Rail systems for supporting medical equipment (ISO 19054:2005)

173.

EN 20594-1:1993

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)

EN 20594-1:1993/A1:1997

EN 20594-1:1993/AC:1996

174.

EN ISO 21534:2009

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

175.

EN ISO 21535:2009

Non-active surgical implants - Joint replacement implants - Specific requirements for hip- joint replacement implants (ISO 21535:2007)

176.

EN ISO 21536:2009

Non-active surgical implants - Joint replacement implants - Specific requirements for knee- joint replacement implants (ISO 21536:2007)

177.

EN ISO 21649:2009

Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

178.

EN ISO 21969:2009

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

179.

EN ISO 21987:2017

Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017)

180.

EN ISO 22442-1:2007

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)

181.

EN ISO 22442-2:2007

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

182.

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 (TSE) agents (ISO 22442-3:2007)

183.

EN ISO 22523:2006

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.

184.

EN ISO 22675:2016

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)

185.

EN ISO 23328-1:2008

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328- 1:2003)

186.

EN ISO 23328-2:2009

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

187.

EN ISO 23747:2009

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

188.

EN ISO 25424:2019

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

189.

EN ISO 25539-1:2009

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

EN ISO 25539-1:2009/AC:2011

190.

EN ISO 25539-2:2009

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539- 2:2008)

EN ISO 25539-2:2009/AC:2011

191.

EN ISO 26782:2009

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)

EN ISO 26782:2009/AC:2009

192.

EN 27740:1992

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 27740:1992/A1:1997

EN 27740:1992/AC:1996

193.

EN 60118-13:2005

Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

194.

EN 60522:1999

Determination of the permanent filtration of X- ray tube assemblies (IEC 60522:1999)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

195.

EN 60580:2000

Medical electrical equipment - Dose area product meters (IEC 60580:2000)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

196.

EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

EN 60601-1:2006/AC:2010

EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)

197.

EN 60601-1-1:2001

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

198.

EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014)

199.

EN 60601-1-3:2008

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008)

EN 60601-1-3:2008/AC:2010

EN 60601-1-3:2008/A11:2016

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

200.

EN 60601-1-4:1996

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996)

EN 60601-1-4:1996/A1:1999 (IEC 60601-1-4:1996/A1:1999)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

201.

EN 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

202.

EN 60601-1-8:2007

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 (IEC 60601-1-8:2006)

EN 60601-1-8:2007/AC:2010

EN 60601-1-8:2007/A11:2017

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

203.

EN 60601-1-10:2008

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

204.

EN 60601-1-11:2010

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 (IEC 60601-1-11:2010)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

205.

EN 60601-2-1:1998

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998)

EN 60601-2-1:1998/A1:2002 (IEC 60601-2-1:1998/A1:2002)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

206.

EN 60601-2-2:2009

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 (IEC 60601-2-2:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

207.

EN 60601-2-3:1993

Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991)

EN 60601-2-3:1993/A1:1998 (IEC 60601-2-3:1991/A1:1998)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

208.

EN 60601-2-4:2003

Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

209.

EN 60601-2-5:2000

Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

210.

EN 60601-2-8:1997

Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987)

EN 60601-2-8:1997/A1:1997 (IEC 60601-2-8:1987/A1:1997)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

211.

EN 60601-2-10:2000

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987)

EN 60601-2-10:2000/A1:2001 (IEC 60601-2-10:1987/A1:2001)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

212.

EN 60601-2-11:1997

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997)

EN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

213.

EN 60601-2-12:2006

Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators (IEC 60601-2-12:2001)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

214.

EN 60601-2-13:2006

Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (IEC 60601-2-13:2003)

EN 60601-2-13:2006/A1:2007 (IEC 60601-2-13:2003/A1:2006)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

215.

EN 60601-2-16:1998

Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998)

EN 60601-2-16:1998/AC:1999

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

216.

EN 60601-2-17:2004

Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

217.

EN 60601-2-18:1996

Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)

EN 60601-2-18:1996/A1:2000 (IEC 60601-2-18:1996/A1:2000)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

218.

EN 60601-2-19:2009

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

219.

EN 60601-2-20:2009

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

220.

EN 60601-2-21:2009

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

221.

EN 60601-2-22:1996

Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995)

Notice: This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

222.

EN 60601-2-23:2000

Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1999)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

223.

EN 60601-2-24:1998

Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

224.

EN 60601-2-25:1995

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993)

EN 60601-2-25:1995/A1:1999 (IEC 60601-2-25:1993/A1:1999)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

225.

EN 60601-2-26:2003

Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

226.

EN 60601-2-27:2006

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005)

EN 60601-2-27:2006/AC:2006

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

227.

EN 60601-2-28:2010

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2010)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

228.

EN 60601-2-29:2008

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

229.

EN 60601-2-30:2000

Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non- invasive blood pressure monitoring equipment (IEC 60601-2-30:1999)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

230.

EN 60601-2-33:2010

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)

EN 60601-2-33:2010/A1:2015 (IEC 60601-2-33:2010/A1:2013)

EN 60601-2-33:2010/A2:2015 (IEC 60601-2-33:2010/A2:2015)

EN 60601-2-33:2010/AC:2016-03

EN 60601-2-33:2010/A12:2016

231.

EN 60601-2-34:2000

Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

232.

EN 60601-2-36:1997

Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

233.

EN 60601-2-37:2008

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

234.

EN 60601-2-39:2008

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

235.

EN 60601-2-40:1998

Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

236.

EN 60601-2-41:2009

Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

237.

EN 60601-2-43:2010

Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

238.

EN 60601-2-44:2009

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

239.

EN 60601-2-45:2001

Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

240.

EN 60601-2-46:1998

Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

241.

EN 60601-2-47:2001

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

242.

EN 60601-2-49:2001

Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

243.

EN 60601-2-50:2009

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

244.

EN 60601-2-51:2003

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

245.

EN 60601-2-52:2010

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

EN 60601-2-52:2010/AC:2011

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

246.

EN 60601-2-54:2009

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

247.

EN 60627:2001

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)

EN 60627:2001/AC:2002

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

248.

EN 60645-1:2001

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers (IEC 60645-1:2001)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

249.

EN 60645-2:1997

Audiometers - Part 2: Equipment for speech audiometry (IEC 60645-2:1993)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

250.

EN 60645-3:2007

Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration (IEC 60645-3:2007)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

251.

EN 60645-4:1995

Audiometers - Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

252.

EN 61217:2012

Radiotherapy equipment - Coordinates, movements and scales (IEC 61217:2011)

253.

EN 61676:2002

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002)

EN 61676:2002/A1:2009 (IEC 61676:2002/A1:2008)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

254.

EN 62083:2009

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

255.

EN 62220-1:2004

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency (IEC 62220-1:2003)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

256.

EN 62220-1-2:2007

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography (IEC 62220-1-2:2007)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

257.

EN 62220-1-3:2008

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging (IEC 62220-1-3:2008)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

258.

EN 62304:2006

Medical device software - Software life-cycle processes (IEC 62304:2006)

EN 62304:2006/AC:2008

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

259.

EN 62366:2008

Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

260.

EN 80601-2-35:2009

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 (IEC 80601-2-35:2009)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

261.

EN 80601-2-58:2009

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 (IEC 80601-2-58:2008)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

262.

EN 80601-2-59:2009

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 80601-2-59:2008)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

263.

EN ISO 81060-1:2012

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

264.

EN ISO 81060-2:2019

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)

---

ANNEX II

| No | Reference of the standard |
| --- | --- |
| 1. | EN ISO 10993-11:2009
  Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| 2. | 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 (ISO 11137-1:2006, including Amd 1:2013) |
| 3. | EN ISO 11990-1:2014
  Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011) |
| 4. | EN ISO 11990-2:2014
  Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010) |
| 5. | EN ISO 13408-2:2011
  Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
| 6. | EN ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  EN ISO 13485:2016/AC:2016 |
| 7. | EN 13976-2:2011
  Rescue systems - Transportation of incubators - Part 2: System requirements |
| 8. | EN 14683:2005
  Surgical masks - Requirements and test methods |
| 9. | EN ISO 15747:2011
  Plastic containers for intravenous injections (ISO 15747:2010) |
| 10. | EN ISO 15883-4:2009
  Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) |
| 11. | EN ISO 17664:2004
  Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) |
| 12. | EN ISO 21987:2009
  Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009) |

No

Reference of the standard

1.

EN ISO 10993-11:2009

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

2.

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 (ISO 11137-1:2006, including Amd 1:2013)

3.

EN ISO 11990-1:2014

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)

4.

EN ISO 11990-2:2014

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)

5.

EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

6.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2016

7.

EN 13976-2:2011

Rescue systems - Transportation of incubators - Part 2: System requirements

8.

EN 14683:2005

Surgical masks - Requirements and test methods

9.

EN ISO 15747:2011

Plastic containers for intravenous injections (ISO 15747:2010)

10.

EN ISO 15883-4:2009

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

11.

EN ISO 17664:2004

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

12.

EN ISO 21987:2009

Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)

---

| 25.3.2020 | EN | Official Journal of the European Union | LI 90/25 |
| --- | --- | --- | --- |

25.3.2020

EN

Official Journal of the European Union

LI 90/25

---

COMMISSION IMPLEMENTING DECISION (EU) 2020/438

of 24 March 2020

on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC

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 Council (1), and in particular Article 10(6) thereof,

Whereas:

| (1) | In accordance with Article 5(1) of Council Directive 90/385/EEC (2) Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of active implantable medical devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union. |
| --- | --- |

(1)

In accordance with Article 5(1) of Council Directive 90/385/EEC (2) Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of active implantable medical devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union.

| (2) | By letters BC/CEN/CENELEC/09/89 of 19 December 1991 and M/295 of 9 September 1999, the Commission made requests to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 90/385/EEC. |
| --- | --- |

(2)

By letters BC/CEN/CENELEC/09/89 of 19 December 1991 and M/295 of 9 September 1999, the Commission made requests to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 90/385/EEC.

| (3) | On the basis of the request M/295 of 9 September 1999, CEN revised the harmonised standard EN ISO 10993-11:2009, the reference of which has been published in the Official Journal of the European Union (3), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standard EN ISO 10993-11:2018. |
| --- | --- |

(3)

On the basis of the request M/295 of 9 September 1999, CEN revised the harmonised standard EN ISO 10993-11:2009, the reference of which has been published in the Official Journal of the European Union (3), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standard EN ISO 10993-11:2018.

| (4) | The Commission together with CEN has assessed whether the harmonised standard EN ISO 10993-11:2018 complies with the request. |
| --- | --- |

(4)

The Commission together with CEN has assessed whether the harmonised standard EN ISO 10993-11:2018 complies with the request.

| (5) | The harmonised standard EN ISO 10993-11:2018 satisfies the requirements which it aims to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union. |
| --- | --- |

(5)

The harmonised standard EN ISO 10993-11:2018 satisfies the requirements which it aims to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union.

| (6) | The harmonised standard EN ISO 10993-11:2018 replaces the harmonised standard EN ISO 10993-11:2009. It is therefore necessary to withdraw the reference of standard EN ISO 10993-11:2009 from the Official Journal of the European Union. In order to give manufacturers sufficient time to adapt their products to the revised specifications in standard EN ISO 10993-11:2018, it is necessary to defer the withdrawal of the reference of standard EN ISO 10993-11:2009. |
| --- | --- |

(6)

The harmonised standard EN ISO 10993-11:2018 replaces the harmonised standard EN ISO 10993-11:2009. It is therefore necessary to withdraw the reference of standard EN ISO 10993-11:2009 from the Official Journal of the European Union. In order to give manufacturers sufficient time to adapt their products to the revised specifications in standard EN ISO 10993-11:2018, it is necessary to defer the withdrawal of the reference of standard EN ISO 10993-11:2009.

| (7) | On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and EN ISO 13485:2016, the references of which have been published in the Official Journal of the European Union (4), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018. |
| --- | --- |

(7)

On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and EN ISO 13485:2016, the references of which have been published in the Official Journal of the European Union (4), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018.

| (8) | The Commission together with CEN has assessed whether the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 comply with the request. |
| --- | --- |

(8)

The Commission together with CEN has assessed whether the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 comply with the request.

| (9) | The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which they aim to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to publish the references of those standards and of the corrigendum in the Official Journal of the European Union. |
| --- | --- |

(9)

The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which they aim to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to publish the references of those standards and of the corrigendum in the Official Journal of the European Union.

| (10) | The harmonised standards EN ISO 11137-1:2015/A2:2019, EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the references of the harmonised standard EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and of corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European Union. In order to give manufacturers sufficient time to adapt their products to the revised specifications in the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018, it is necessary to defer the withdrawal of the references of harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and of corrigendum EN ISO 13485:2016/AC:2016. |
| --- | --- |

(10)

The harmonised standards EN ISO 11137-1:2015/A2:2019, EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the references of the harmonised standard EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and of corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European Union. In order to give manufacturers sufficient time to adapt their products to the revised specifications in the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018, it is necessary to defer the withdrawal of the references of harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and of corrigendum EN ISO 13485:2016/AC:2016.

| (11) | On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN drafted the new harmonised standard EN ISO 25424:2019. The Commission together with CEN has assessed whether that standard complies with the request. |
| --- | --- |

(11)

On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN drafted the new harmonised standard EN ISO 25424:2019. The Commission together with CEN has assessed whether that standard complies with the request.

| (12) | The harmonised standard EN ISO 25424:2019 satisfies the requirements which it aims to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union. |
| --- | --- |

(12)

The harmonised standard EN ISO 25424:2019 satisfies the requirements which it aims to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union.

| (13) | In the interests of clarity and legal certainty, a complete list of references of harmonised standards drafted in support of Directive 90/385/EEC and satisfying the essential requirements they aim to cover should be published in one act. The other references of standards published in the Commission communication 2017/C 389/02 (5) should therefore also be included in this Decision. That Communication should therefore be repealed from the date of entry into force of this Decision. However, it should continue to apply in respect of the references of the harmonised standards that are withdrawn by this Decision, given that it is necessary to defer withdrawal of those references. |
| --- | --- |

(13)

In the interests of clarity and legal certainty, a complete list of references of harmonised standards drafted in support of Directive 90/385/EEC and satisfying the essential requirements they aim to cover should be published in one act. The other references of standards published in the Commission communication 2017/C 389/02 (5) should therefore also be included in this Decision. That Communication should therefore be repealed from the date of entry into force of this Decision. However, it should continue to apply in respect of the references of the harmonised standards that are withdrawn by this Decision, given that it is necessary to defer withdrawal of those references.

| (14) | In accordance with the second subparagraph of Article 120(2) of Regulation (EU) 2017/745 of the European Parliament and of the Council (6), certificates issued by notified bodies in accordance with Directive 90/385/EEC from 25 May 2017 are to remain valid until the end of the period indicated on the certificate, which is not to exceed five years from its issuance. They are, however, to become void at the latest on 27 May 2024. In accordance with the first subparagraph of Article 120(3) of Regulation (EU) 2017/745 a device which has a certificate that was issued in accordance with Directive 90/385/EEC and that is valid by virtue of Article 120(2) of Regulation (EU) 2017/745, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with Directive 90/385/EEC, and provided there are no significant changes in the design and intended purpose. This Decision should therefore apply only until 26 May 2024. |
| --- | --- |

(14)

In accordance with the second subparagraph of Article 120(2) of Regulation (EU) 2017/745 of the European Parliament and of the Council (6), certificates issued by notified bodies in accordance with Directive 90/385/EEC from 25 May 2017 are to remain valid until the end of the period indicated on the certificate, which is not to exceed five years from its issuance. They are, however, to become void at the latest on 27 May 2024. In accordance with the first subparagraph of Article 120(3) of Regulation (EU) 2017/745 a device which has a certificate that was issued in accordance with Directive 90/385/EEC and that is valid by virtue of Article 120(2) of Regulation (EU) 2017/745, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with Directive 90/385/EEC, and provided there are no significant changes in the design and intended purpose. This Decision should therefore apply only until 26 May 2024.

| (15) | The requirements for implantable medical devices laid down in Directive 90/385/EEC are different from those laid down in Regulation (EU) 2017/745. The standards drafted in support of Directive 90/385/EEC should therefore not be used to demonstrate conformity with the requirements of Regulation (EU) 2017/745. |
| --- | --- |

(15)

The requirements for implantable medical devices laid down in Directive 90/385/EEC are different from those laid down in Regulation (EU) 2017/745. The standards drafted in support of Directive 90/385/EEC should therefore not be used to demonstrate conformity with the requirements of Regulation (EU) 2017/745.

| (16) | Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication, |
| --- | --- |

(16)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication,

HAS ADOPTED THIS DECISION:

Article 1

The references of the harmonised standards for active implantable medical devices drafted in support of Directive 90/385/EEC and listed in Annex I to this Decision are hereby published in the Official Journal of the European Union.

Article 2

Commission communication 2017/C 389/02 is repealed. It shall continue to apply until 30 September 2021 in respect of the references of the harmonised standards listed in Annex II to this Decision.

Article 3

The harmonised standards for active implantable medical devices drafted in support of Directive 90/385/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745.

Article 4

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply until 26 May 2024.

Done at Brussels, 24 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 316, 14.11.2012, p. 12.

1

(2)  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).

2

(3)  
  OJ C 389, 17.11.2017, p. 22.

3

(4)  
  OJ C 389, 17.11.2017, p. 22.

4

(5)  Commission communication in the framework of the implementation of Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (2017/C 389/02) (OJ C 389, 17.11.2017, p. 22).

5

(6)  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).

6

---

ANNEX I

| No | Reference of the standard |
| --- | --- |
| 1. | EN 556-1:2001
  Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  EN 556-1:2001/AC:2006 |
| 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 |
| 3. | EN 1041:2008
  Information supplied by the manufacturer of medical devices |
| 4. | EN ISO 10993-1:2009
  Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
  EN ISO 10993-1:2009/AC:2010 |
| 5. | EN ISO 10993-3:2014
  Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
| 6. | EN ISO 10993-4:2009
  Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
| 7. | EN ISO 10993-5:2009
  Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| 8. | EN ISO 10993-6:2009
  Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
| 9. | EN ISO 10993-7:2008
  Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
  EN ISO 10993-7:2008/AC:2009 |
| 10. | EN ISO 10993-9:2009
  Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
| 11. | EN ISO 10993-11:2018
  Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017) |
| 12. | EN ISO 10993-12:2012
  Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| 13. | EN ISO 10993-13:2010
  Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| 14. | EN ISO 10993-16:2010
  Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
| 15. | EN ISO 10993-17:2009
  Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| 16. | EN ISO 10993-18:2009
  Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| 17. | EN ISO 11135-1:2007
  Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
| 18. | 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 (ISO 11137-1:2006, including Amd 1:2013)
  EN ISO 11137-1:2015/A2:2019 |
| 19. | EN ISO 11137-2:2015
  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| 20. | EN ISO 11138-2:2009
  Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
| 21. | EN ISO 11138-3:2009
  Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
| 22. | EN ISO 11140-1:2009
  Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) |
| 23. | EN ISO 11607-1:2009
  Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
| 24. | EN ISO 11737-1:2006
  Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
  EN ISO 11737-1:2006/AC:2009 |
| 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 (ISO 11737-2:2009) |
| 26. | EN ISO 13408-1:2015
  Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| 27. | EN ISO 13408-2:2018
  Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| 28. | EN ISO 13408-3:2011
  Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) |
| 29. | EN ISO 13408-4:2011
  Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
| 30. | EN ISO 13408-5:2011
  Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| 31. | EN ISO 13408-6:2011
  Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) |
| 32. | EN ISO 13408-7:2015
  Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
| 33. | EN ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  EN ISO 13485:2016/AC:2018 |
| 34. | EN ISO 14155:2011
  Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
  EN ISO 14155:2011/AC:2011 |
| 35. | 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 (ISO 14937:2009) |
| 36. | EN ISO 14971:2012
  Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| 37. | 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 (ISO 15223-1:2016, Corrected version 2017-03) |
| 38. | 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 (ISO 17665-1:2006) |
| 39. | EN ISO 25424:2019
  Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
| 40. | EN 45502-1:1997
  Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
| 41. | EN 45502-2-1:2003
  Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 42. | EN 45502-2-2:2008
  Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
  EN 45502-2-2:2008/AC:2009
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 43. | EN 45502-2-3:2010
  Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 44. | EN 60601-1:2006
  Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
  EN 60601-1:2006/AC:2010
  EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012) |
| 45. | EN 60601-1-6:2010
  Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| 46. | EN 62304:2006
  Medical device software - Software life-cycle processes (IEC 62304:2006)
  EN 62304:2006/AC:2008
  Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |

No

Reference of the standard

1.

EN 556-1:2001

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

EN 556-1:2001/AC:2006

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

3.

EN 1041:2008

Information supplied by the manufacturer of medical devices

4.

EN ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-1:2009/AC:2010

5.

EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

6.

EN ISO 10993-4:2009

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

7.

EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

8.

EN ISO 10993-6:2009

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

9.

EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008/AC:2009

10.

EN ISO 10993-9:2009

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

11.

EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

12.

EN ISO 10993-12:2012

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

13.

EN ISO 10993-13:2010

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

14.

EN ISO 10993-16:2010

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

15.

EN ISO 10993-17:2009

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

16.

EN ISO 10993-18:2009

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

17.

EN ISO 11135-1:2007

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

18.

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 (ISO 11137-1:2006, including Amd 1:2013)

EN ISO 11137-1:2015/A2:2019

19.

EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

20.

EN ISO 11138-2:2009

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

21.

EN ISO 11138-3:2009

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

22.

EN ISO 11140-1:2009

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

23.

EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

24.

EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

EN ISO 11737-1:2006/AC:2009

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 (ISO 11737-2:2009)

26.

EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

27.

EN ISO 13408-2:2018

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

28.

EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

29.

EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

30.

EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

31.

EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

32.

EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

33.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2018

34.

EN ISO 14155:2011

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

EN ISO 14155:2011/AC:2011

35.

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 (ISO 14937:2009)

36.

EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

37.

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 (ISO 15223-1:2016, Corrected version 2017-03)

38.

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 (ISO 17665-1:2006)

39.

EN ISO 25424:2019

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

40.

EN 45502-1:1997

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

41.

EN 45502-2-1:2003

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

42.

EN 45502-2-2:2008

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

EN 45502-2-2:2008/AC:2009

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

43.

EN 45502-2-3:2010

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

44.

EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

EN 60601-1:2006/AC:2010

EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)

45.

EN 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

46.

EN 62304:2006

Medical device software - Software life-cycle processes (IEC 62304:2006)

EN 62304:2006/AC:2008

Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

---

ANNEX II

| No | Reference of the standard |
| --- | --- |
| 1. | EN ISO 10993-11:2009
  Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| 2. | 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 (ISO 11137-1:2006, including Amd 1:2013) |
| 3. | EN ISO 13408-2:2011
  Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
| 4. | EN ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  EN ISO 13485:2016/AC:2016 |

No

Reference of the standard

1.

EN ISO 10993-11:2009

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

2.

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 (ISO 11137-1:2006, including Amd 1:2013)

3.

EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

4.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2016

---

| 25.3.2020 | EN | Official Journal of the European Union | LI 90/33 |
| --- | --- | --- | --- |

25.3.2020

EN

Official Journal of the European Union

LI 90/33

---

COMMISSION IMPLEMENTING DECISION (EU) 2020/439

of 24 March 2020

on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council

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 Council (1), and in particular Article 10(6) thereof,

Whereas:

| (1) | In accordance with Article 5(1) of Directive 98/79/EC of the European Parliament and of the Council (2), Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of in vitro diagnostic medical devices which are in conformity with the relevant national standards transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Union. |
| --- | --- |

(1)

In accordance with Article 5(1) of Directive 98/79/EC of the European Parliament and of the Council (2), Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of in vitro diagnostic medical devices which are in conformity with the relevant national standards transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Union.

| (2) | By letter BC/CEN/CENELEC/09/89 of 19 December 1991, the Commission made a request to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 98/79/EC. |
| --- | --- |

(2)

By letter BC/CEN/CENELEC/09/89 of 19 December 1991, the Commission made a request to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 98/79/EC.

| (3) | On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and EN ISO 13485:2016, the references of which have been published in the Official Journal of the European Union (3), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018. |
| --- | --- |

(3)

On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and EN ISO 13485:2016, the references of which have been published in the Official Journal of the European Union (3), in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018.

| (4) | The Commission together with CEN has assessed whether the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 comply with the request. |
| --- | --- |

(4)

The Commission together with CEN has assessed whether the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 comply with the request.

| (5) | The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which they aim to cover and which are set out in Directive 98/79/EC. It is therefore appropriate to publish the references of those standards and of the corrigendum in the Official Journal of the European Union. |
| --- | --- |

(5)

The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which they aim to cover and which are set out in Directive 98/79/EC. It is therefore appropriate to publish the references of those standards and of the corrigendum in the Official Journal of the European Union.

| (6) | The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the references of the harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European Union. In order to give manufacturers sufficient time to adapt their products to the revised specifications in standards EN ISO 11137-1:2015/A2:2019, EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018, it is necessary to defer the withdrawal of the reference of the standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016. |
| --- | --- |

(6)

The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the references of the harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European Union. In order to give manufacturers sufficient time to adapt their products to the revised specifications in standards EN ISO 11137-1:2015/A2:2019, EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018, it is necessary to defer the withdrawal of the reference of the standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016.

| (7) | On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN drafted the new harmonised standard EN ISO 25424:2019. The Commission together with CEN has assessed whether that standard complies with the request. |
| --- | --- |

(7)

On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN drafted the new harmonised standard EN ISO 25424:2019. The Commission together with CEN has assessed whether that standard complies with the request.

| (8) | The harmonised standard EN ISO 25424:2019 satisfies the requirements which it aims to cover and which are set out in Directive 98/79/EC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union. |
| --- | --- |

(8)

The harmonised standard EN ISO 25424:2019 satisfies the requirements which it aims to cover and which are set out in Directive 98/79/EC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union.

| (9) | In the interests of clarity and legal certainty, a complete list of references of harmonised standards drafted in support of Directive 98/79/EC and satisfying the essential requirements they aim to cover should be published in one act. The other references of standards published in the Commission communication 2017/C 389/04 (4) should therefore also be included in this Decision. That Communication should therefore be repealed from the date of entry into force of this Decision. However, it should continue to apply in respect of the references of the standards that are withdrawn by this Decision, given that it is necessary to defer the withdrawal of those references. |
| --- | --- |

(9)

In the interests of clarity and legal certainty, a complete list of references of harmonised standards drafted in support of Directive 98/79/EC and satisfying the essential requirements they aim to cover should be published in one act. The other references of standards published in the Commission communication 2017/C 389/04 (4) should therefore also be included in this Decision. That Communication should therefore be repealed from the date of entry into force of this Decision. However, it should continue to apply in respect of the references of the standards that are withdrawn by this Decision, given that it is necessary to defer the withdrawal of those references.

| (10) | In accordance with the second subparagraph of Article 110(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council (5) certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 are to become void by 27 May 2024. In accordance with the first subparagraph of Article 110(3) of Regulation (EU) 2017/746 a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of Article 110(2) of Regulation (EU) 2017/746 may only be placed on the market or put into service provided that from 26 May 2022 it continues to comply with Directive 98/79/EC, and provided there are no significant changes in the design and intended purpose. This Decision should therefore apply only until 26 May 2024. |
| --- | --- |

(10)

In accordance with the second subparagraph of Article 110(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council (5) certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 are to become void by 27 May 2024. In accordance with the first subparagraph of Article 110(3) of Regulation (EU) 2017/746 a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of Article 110(2) of Regulation (EU) 2017/746 may only be placed on the market or put into service provided that from 26 May 2022 it continues to comply with Directive 98/79/EC, and provided there are no significant changes in the design and intended purpose. This Decision should therefore apply only until 26 May 2024.

| (11) | The requirements for in vitro diagnostic medical devices laid down in Directive 98/79/EC are different from those laid down in Regulation (EU) 2017/746. The standards drafted in support of Directive 98/79/EC should therefore not be used to demonstrate conformity with the requirements of Regulation (EU) 2017/746. |
| --- | --- |

(11)

The requirements for in vitro diagnostic medical devices laid down in Directive 98/79/EC are different from those laid down in Regulation (EU) 2017/746. The standards drafted in support of Directive 98/79/EC should therefore not be used to demonstrate conformity with the requirements of Regulation (EU) 2017/746.

| (12) | Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication, |
| --- | --- |

(12)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication,

HAS ADOPTED THIS DECISION:

Article 1

The references of the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC and listed in Annex I to this Decision are hereby published in the Official Journal of the European Union.

Article 2

Commission communication 2017/C 389/04 is repealed. It shall continue to apply until 30 September 2021 in respect of the references of the harmonised standards listed in Annex II to this Decision.

Article 3

The harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/746.

Article 4

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply until 26 May 2024.

Done at Brussels, 24 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 316, 14.11.2012, p. 12.

1

(2)  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).

2

(3)  
  OJ C 389, 17.11.2017, p. 62.

3

(4)  Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (2017/C 389/04) (OJ C 389, 17.11.2017, p. 62).

4

in vitro

(5)  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).

5

in vitro

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ANNEX I

| No | Reference of the standard |
| --- | --- |
| 1. | EN 556-1:2001
  Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  EN 556-1:2001/AC:2006 |
| 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 |
| 3. | 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 (ISO 11137-1:2006, including Amd 1:2013)
  EN ISO 11137-1:2015/A2:2019 |
| 4. | EN ISO 11137-2:2015
  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| 5. | 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 (ISO 11737-2:2009) |
| 6. | EN 12322:1999
  In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
  EN 12322:1999/A1:2001 |
| 7. | EN ISO 13408-1:2015
  Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| 8. | EN ISO 13408-2:2018
  Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| 9. | EN ISO 13408-3:2011
  Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) |
| 10. | EN ISO 13408-4:2011
  Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
| 11. | EN ISO 13408-5:2011
  Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| 12. | EN ISO 13408-6:2011
  Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) |
| 13. | EN ISO 13408-7:2015
  Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
| 14. | EN ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  EN ISO 13485:2016/AC:2018 |
| 15. | EN 13532:2002
  General requirements for in vitro diagnostic medical devices for self-testing |
| 16. | EN 13612:2002
  Performance evaluation of in vitro diagnostic medical devices
  EN 13612:2002/AC:2002 |
| 17. | EN 13641:2002
  Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| 18. | EN 13975:2003
  Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| 19. | EN 14136:2004
  Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| 20. | EN 14254:2004
  In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| 21. | EN 14820:2004
  Single-use containers for human venous blood specimen collection |
| 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 (ISO 14937:2009) |
| 23. | EN ISO 14971:2012
  Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| 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 (ISO 15193:2009) |
| 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 (ISO 15194:2009) |
| 26. | EN ISO 15197:2015
  In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| 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 (ISO 15223-1:2016, Corrected version 2017-03) |
| 28. | EN ISO 17511:2003
  In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
| 29. | EN ISO 18113-1:2011
  In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| 30. | 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 (ISO 18113-2:2009) |
| 31. | 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 (ISO 18113-3:2009) |
| 32. | 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 (ISO 18113-4:2009) |
| 33. | EN ISO 18113-5:2011
  In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| 34. | EN ISO 18153:2003
  In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) |
| 35. | EN ISO 20776-1:2006
  Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006) |
| 36. | EN ISO 23640:2015
  In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
| 37. | EN ISO 25424:2019
  Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
| 38. | EN 61010-2-101:2002
  Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| 39. | EN 61326-2-6:2006
  Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 40. | EN 62304:2006
  Medical device software - Software life-cycle processes (IEC 62304:2006)
  EN 62304:2006/AC:2008 |
| 41. | EN 62366:2008
  Medical devices - Application of usability engineering to medical devices |

No

Reference of the standard

1.

EN 556-1:2001

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

EN 556-1:2001/AC:2006

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

3.

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 (ISO 11137-1:2006, including Amd 1:2013)

EN ISO 11137-1:2015/A2:2019

4.

EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

5.

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 (ISO 11737-2:2009)

6.

EN 12322:1999

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN 12322:1999/A1:2001

7.

EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

8.

EN ISO 13408-2:2018

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

9.

EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

10.

EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

11.

EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

12.

EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

13.

EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

14.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2018

15.

EN 13532:2002

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

16.

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002/AC:2002

17.

EN 13641:2002

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

18.

EN 13975:2003

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

19.

EN 14136:2004

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

20.

EN 14254:2004

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

21.

EN 14820:2004

Single-use containers for human venous blood specimen collection

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 (ISO 14937:2009)

23.

EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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 (ISO 15193:2009)

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 (ISO 15194:2009)

26.

EN ISO 15197:2015

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

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 (ISO 15223-1:2016, Corrected version 2017-03)

28.

EN ISO 17511:2003

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

29.

EN ISO 18113-1:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

30.

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 (ISO 18113-2:2009)

31.

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 (ISO 18113-3:2009)

32.

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 (ISO 18113-4:2009)

33.

EN ISO 18113-5:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

34.

EN ISO 18153:2003

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

35.

EN ISO 20776-1:2006

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

36.

EN ISO 23640:2015

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

37.

EN ISO 25424:2019

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

38.

EN 61010-2-101:2002

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

39.

EN 61326-2-6:2006

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

40.

EN 62304:2006

Medical device software - Software life-cycle processes (IEC 62304:2006)

EN 62304:2006/AC:2008

41.

EN 62366:2008

Medical devices - Application of usability engineering to medical devices

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ANNEX II

| No | Reference of the standard |
| --- | --- |
| 1. | 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 (ISO 11137-1:2006, including Amd 1:2013) |
| 2. | EN ISO 13408-2:2011
  Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
| 3. | EN ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  EN ISO 13485:2016/AC:2016 |

No

Reference of the standard

1.

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 (ISO 11137-1:2006, including Amd 1:2013)

2.

EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

3.

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/AC:2016

---