# C_2016173EN.01009201.xml

| 13.5.2016 | EN | Official Journal of the European Union | C 173/92 |
| --- | --- | --- | --- |

13.5.2016

EN

Official Journal of the European Union

C 173/92

---

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

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2016/C 173/02)

| ESO (1) | Reference and title of the standard
  (and reference document) | First publication OJ | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices | 31.7.2002 | EN 556:1994 + A1:1998
  Note 2.1 | Date expired
  (30.4.2002) |
| | EN 556-1:2001/AC:2006 | 15.11.2006 | | |
| CEN | EN 556-2:2015
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | This is the first publication | EN 556-2:2003
  Note 2.1 | 30.6.2016 |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | 23.7.2008 | EN 980:2003
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN 1041:2008
  Information supplied by the manufacturer of medical devices | 19.2.2009 | EN 1041:1998
  Note 2.1 | Date expired
  (31.8.2011) |
| CEN | EN ISO 10993-1:2009
  Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) | 2.12.2009 | EN ISO 10993-1:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| | EN ISO 10993-1:2009/AC:2010 | 18.1.2011 | | |
| CEN | EN ISO 10993-3:2014
  Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) | 10.7.2015 | | |
| CEN | 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) | 2.12.2009 | EN ISO 10993-4:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-5:2009
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) | 2.12.2009 | EN ISO 10993-5:1999
  Note 2.1 | Date expired
  (31.12.2009) |
| CEN | EN ISO 10993-6:2009
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | 2.12.2009 | EN ISO 10993-6:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-7:2008
  Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) | 7.7.2010 | | |
| | EN ISO 10993-7:2008/AC:2009 | 7.7.2010 | | |
| CEN | 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) | 2.12.2009 | EN ISO 10993-9:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-11:2009
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | 2.12.2009 | EN ISO 10993-11:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-12:2012
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012) | 24.1.2013 | EN ISO 10993-12:2009
  Note 2.1 | Date expired
  (31.1.2013) |
| CEN | 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) | 18.1.2011 | EN ISO 10993-13:2009
  Note 2.1 | Date expired
  (31.12.2010) |
| CEN | EN ISO 10993-16:2010
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) | 7.7.2010 | EN ISO 10993-16:2009
  Note 2.1 | Date expired
  (31.8.2010) |
| CEN | EN ISO 10993-17:2009
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | 2.12.2009 | EN ISO 10993-17:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-18:2009
  Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) | 2.12.2009 | EN ISO 10993-18:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | 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) | 9.8.2007 | EN 550:1994
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | 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) | This is the first publication | EN ISO 11137-1:2006
  Note 2.1 | 30.6.2016 |
| CEN | EN ISO 11137-2:2015
  Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | This is the first publication | EN ISO 11137-2:2013
  Note 2.1 | 30.6.2016 |
| CEN | 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) | 2.12.2009 | EN ISO 11138-2:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | 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) | 2.12.2009 | EN ISO 11138-3:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11140-1:2009
  Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | 2.12.2009 | EN ISO 11140-1:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | 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) | 2.12.2009 | EN ISO 11607-1:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | 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) | 7.9.2006 | EN 1174-1:1996
  EN 1174-2:1996
  EN 1174-3:1996
  Note 2.1 | Date expired
  (31.10.2006) |
| | EN ISO 11737-1:2006/AC:2009 | 2.12.2009 | | |
| CEN | 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) | 7.7.2010 | | |
| CEN | EN ISO 13408-1:2015
  Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) | This is the first publication | EN ISO 13408-1:2011
  Note 2.1 | 30.6.2016 |
| CEN | EN ISO 13408-2:2011
  Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-3:2011
  Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-4:2011
  Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-5:2011
  Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-6:2011
  Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | 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) | This is the first publication | | |
| CEN | EN ISO 13485:2012
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | 30.8.2012 | EN ISO 13485:2003
  Note 2.1 | Date expired
  (30.8.2012) |
| | EN ISO 13485:2012/AC:2012 | 30.8.2012 | | |
| CEN | EN ISO 14155:2011
  Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011) | 27.4.2012 | EN ISO 14155:2011
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | 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) | 7.7.2010 | EN ISO 14937:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 14971:2012
  Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 30.8.2012 | EN ISO 14971:2009
  Note 2.1 | Date expired
  (30.8.2012) |
| CEN | 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) | 15.11.2006 | EN 554:1994
  Note 2.1 | Date expired
  (31.8.2009) |
| Cenelec | EN 45502-1:1997
  Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer | 27.8.1998 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | 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) | 8.7.2004 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | 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) | 27.11.2008 | | |
| | EN 45502-2-2:2008/AC:2009 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 45502-2-3:2010
  Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  IEC 60601-1:2005 | 27.11.2008 | EN 60601-1:1990
  - A13:1996
  - A1:1993
  - A2:1995
  Note 2.1 | Date expired
  (1.6.2012) |
| | EN 60601-1:2006/AC:2010 | 18.1.2011 | | |
| | EN 60601-1:2006/A1:2013
  IEC 60601-1:2005/A1:2012 | 10.7.2015 | Note 3 | 31.12.2017 |
| Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.
  The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 90/385/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 90/385/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013. |
| Cenelec | 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 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  IEC 62304:2006 | 27.11.2008 | | |
| | EN 62304:2006/AC:2008 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |

ESO (1)

1

Reference and title of the standard

(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

(1)

(2)

(3)

(4)

(5)

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

31.7.2002

EN 556:1994 + A1:1998

Note 2.1

Date expired

(30.4.2002)

EN 556-1:2001/AC:2006

15.11.2006

CEN

EN 556-2:2015

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

This is the first publication

EN 556-2:2003

Note 2.1

30.6.2016

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

23.7.2008

EN 980:2003

Note 2.1

Date expired

(31.5.2010)

CEN

EN 1041:2008

Information supplied by the manufacturer of medical devices

19.2.2009

EN 1041:1998

Note 2.1

Date expired

(31.8.2011)

CEN

EN ISO 10993-1:2009

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

2.12.2009

EN ISO 10993-1:2009

Note 2.1

Date expired

(21.3.2010)

EN ISO 10993-1:2009/AC:2010

18.1.2011

CEN

EN ISO 10993-3:2014

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

10.7.2015

CEN

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)

2.12.2009

EN ISO 10993-4:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-5:2009

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

2.12.2009

EN ISO 10993-5:1999

Note 2.1

Date expired

(31.12.2009)

CEN

EN ISO 10993-6:2009

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

2.12.2009

EN ISO 10993-6:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-7:2008

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

7.7.2010

EN ISO 10993-7:2008/AC:2009

7.7.2010

CEN

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)

2.12.2009

EN ISO 10993-9:2009

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-11:2009

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

2.12.2009

EN ISO 10993-11:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-12:2012

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

24.1.2013

EN ISO 10993-12:2009

Note 2.1

Date expired

(31.1.2013)

CEN

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)

18.1.2011

EN ISO 10993-13:2009

Note 2.1

Date expired

(31.12.2010)

CEN

EN ISO 10993-16:2010

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

7.7.2010

EN ISO 10993-16:2009

Note 2.1

Date expired

(31.8.2010)

CEN

EN ISO 10993-17:2009

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

2.12.2009

EN ISO 10993-17:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-18:2009

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

2.12.2009

EN ISO 10993-18:2005

Note 2.1

Date expired

(21.3.2010)

CEN

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)

9.8.2007

EN 550:1994

Note 2.1

Date expired

(31.5.2010)

CEN

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)

This is the first publication

EN ISO 11137-1:2006

Note 2.1

30.6.2016

CEN

EN ISO 11137-2:2015

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

This is the first publication

EN ISO 11137-2:2013

Note 2.1

30.6.2016

CEN

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)

2.12.2009

EN ISO 11138-2:2006

Note 2.1

Date expired

(21.3.2010)

CEN

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)

2.12.2009

EN ISO 11138-3:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11140-1:2009

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

2.12.2009

EN ISO 11140-1:2005

Note 2.1

Date expired

(21.3.2010)

CEN

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)

2.12.2009

EN ISO 11607-1:2006

Note 2.1

Date expired

(21.3.2010)

CEN

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)

7.9.2006

EN 1174-1:1996

EN 1174-2:1996

EN 1174-3:1996

Note 2.1

Date expired

(31.10.2006)

EN ISO 11737-1:2006/AC:2009

2.12.2009

CEN

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)

7.7.2010

CEN

EN ISO 13408-1:2015

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

This is the first publication

EN ISO 13408-1:2011

Note 2.1

30.6.2016

CEN

EN ISO 13408-2:2011

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

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-3:2011

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

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-4:2011

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

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-5:2011

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

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-6:2011

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

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

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)

This is the first publication

CEN

EN ISO 13485:2012

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

30.8.2012

EN ISO 13485:2003

Note 2.1

Date expired

(30.8.2012)

EN ISO 13485:2012/AC:2012

30.8.2012

CEN

EN ISO 14155:2011

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

27.4.2012

EN ISO 14155:2011

Note 2.1

Date expired

(30.4.2012)

CEN

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)

7.7.2010

EN ISO 14937:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 14971:2012

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

30.8.2012

EN ISO 14971:2009

Note 2.1

Date expired

(30.8.2012)

CEN

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)

15.11.2006

EN 554:1994

Note 2.1

Date expired

(31.8.2009)

Cenelec

EN 45502-1:1997

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

27.8.1998

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

Cenelec

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)

8.7.2004

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

Cenelec

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)

27.11.2008

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

18.1.2011

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

Cenelec

EN 45502-2-3:2010

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

18.1.2011

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

Cenelec

EN 60601-1:2006

Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

IEC 60601-1:2005

27.11.2008

EN 60601-1:1990

- A13:1996

- A1:1993

- A2:1995

Note 2.1

Date expired

(1.6.2012)

EN 60601-1:2006/AC:2010

18.1.2011

EN 60601-1:2006/A1:2013

IEC 60601-1:2005/A1:2012

10.7.2015

Note 3

31.12.2017

Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.

The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 90/385/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 90/385/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.

Cenelec

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

18.1.2011

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

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

IEC 62304:2006

27.11.2008

EN 62304:2006/AC:2008

18.1.2011

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

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1:

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.2: | The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.2:

The new standard has a broader scope than the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated, the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
| --- | --- |

Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated, the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2). |
| --- | --- |

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Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2).

Official Journal of the European Union

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| — | Standards are adopted by the European standardisation organisations in English (CEN and CENELEC also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
| --- | --- |

—

Standards are adopted by the European standardisation organisations in English (CEN and CENELEC also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

| — | References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
| --- | --- |

—

References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation.

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.

Official Journal of the European Union

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.

Official Journal of the European Union

| — | More information about harmonised standards and other European standards on the Internet at:
  http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm |
| --- | --- |

—

More information about harmonised standards and other European standards on the Internet at:

http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm

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(1)  ESO: European standardisation organisation:

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| — | CEN: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25500811; fax +32 25500819 (http://www.cen.eu) |
| --- | --- |

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CEN: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25500811; fax +32 25500819 (http://www.cen.eu)

| — | CENELEC: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu) |
| --- | --- |

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CENELEC: Avenue Marnix/Marnixlaan 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË; tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu)

| — | ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE; tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu) |
| --- | --- |

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ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE; tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu)

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

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