# C_2011016EN.01003701.xml

| 18.1.2011 | EN | Official Journal of the European Union | C 16/37 |
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18.1.2011

EN

Official Journal of the European Union

C 16/37

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Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

(Publication of titles and references of harmonised standards under the directive)

2011/C 16/03

| ESO (1) | Reference and title of the harmonised standard
  (and reference document) | First publication OJ | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| 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 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | 9.8.2007 | | |
| 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 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 12322:1999
  In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media | 9.10.1999 | | |
| EN 12322:1999/A1:2001 | 31.7.2002 | Note 3 | Date expired
  (30.4.2002) |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | 2.4.2004 | EN ISO 13488:2000
  EN ISO 13485:2000
  Note 2.1 | Date expired
  (31.7.2009) |
| EN ISO 13485:2003/AC:2009 | 7.7.2010 | | |
| CEN | EN 13532:2002
  General requirements for in vitro diagnostic medical devices for self-testing | 17.12.2002 | | |
| CEN | EN 13612:2002
  Performance evaluation of in vitro diagnostic medical devices | 17.12.2002 | | |
| EN 13612:2002/AC:2002 | 2.12.2009 | | |
| CEN | EN 13640:2002
  Stability testing of in vitro diagnostic reagents | 17.12.2002 | | |
| CEN | EN 13641:2002
  Elimination or reduction of risk of infection related to in vitro diagnostic reagents | 17.12.2002 | | |
| CEN | EN 13975:2003
  Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects | 21.11.2003 | | |
| CEN | EN 14136:2004
  Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures | 15.11.2006 | | |
| CEN | EN 14254:2004
  In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans | 28.4.2005 | | |
| CEN | EN 14820:2004
  Single-use containers for human venous blood specimen collection | 28.4.2005 | | |
| 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
  (30.4.2010) |
| CEN | EN ISO 14971:2009
  Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 7.7.2010 | EN ISO 14971:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | 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) | 7.7.2010 | | |
| CEN | 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) | 7.7.2010 | | |
| CEN | EN ISO 15197:2003
  In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) | 28.4.2005 | | |
| EN ISO 15197:2003/AC:2005 | 2.12.2009 | | |
| CEN | 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) | 28.4.2005 | | |
| CEN | EN ISO 18113-1:2009
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) | 7.7.2010 | | |
| CEN | EN ISO 18113-2:2009
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) | 7.7.2010 | EN 375:2001
  Note 2.1 | 31.12.2012 |
| CEN | EN ISO 18113-3:2009
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) | 7.7.2010 | EN 591:2001
  Note 2.1 | 31.12.2012 |
| CEN | EN ISO 18113-4:2009
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) | 7.7.2010 | EN 376:2002
  Note 2.1 | 31.12.2012 |
| CEN | EN ISO 18113-5:2009
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) | 7.7.2010 | EN 592:2002
  Note 2.1 | 31.12.2012 |
| CEN | 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) | 21.11.2003 | | |
| CEN | 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) | 9.8.2007 | | |
| Cenelec | 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
  IEC 61010-2-101:2002 (Modified) | 17.12.2002 | | |
| Cenelec | 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
  IEC 61326-2-6:2005 | 27.11.2008 | | |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  IEC 62304:2006 | 27.11.2008 | | |
| EN 62304:2006/AC:2008 | This is the first publication | | |
| Cenelec | EN 62366:2008
  Medical devices — Application of usability engineering to medical devices
  IEC 62366:2007 | 27.11.2008 | | |

ESO (1)

1

Reference and title of the harmonised standard

(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

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 556-2:2003

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

9.8.2007

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 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 12322:1999

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

9.10.1999

EN 12322:1999/A1:2001

31.7.2002

Note 3

Date expired

(30.4.2002)

CEN

EN ISO 13485:2003

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

2.4.2004

EN ISO 13488:2000

EN ISO 13485:2000

Note 2.1

Date expired

(31.7.2009)

EN ISO 13485:2003/AC:2009

7.7.2010

CEN

EN 13532:2002

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

17.12.2002

CEN

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

17.12.2002

EN 13612:2002/AC:2002

2.12.2009

CEN

EN 13640:2002

Stability testing of in vitro diagnostic reagents

17.12.2002

CEN

EN 13641:2002

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

17.12.2002

CEN

EN 13975:2003

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

21.11.2003

CEN

EN 14136:2004

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

15.11.2006

CEN

EN 14254:2004

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

28.4.2005

CEN

EN 14820:2004

Single-use containers for human venous blood specimen collection

28.4.2005

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

(30.4.2010)

CEN

EN ISO 14971:2009

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

7.7.2010

EN ISO 14971:2007

Note 2.1

Date expired

(21.3.2010)

CEN

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)

7.7.2010

CEN

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)

7.7.2010

CEN

EN ISO 15197:2003

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

28.4.2005

EN ISO 15197:2003/AC:2005

2.12.2009

CEN

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)

28.4.2005

CEN

EN ISO 18113-1:2009

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

7.7.2010

CEN

EN ISO 18113-2:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

7.7.2010

EN 375:2001

Note 2.1

31.12.2012

CEN

EN ISO 18113-3:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

7.7.2010

EN 591:2001

Note 2.1

31.12.2012

CEN

EN ISO 18113-4:2009

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

7.7.2010

EN 376:2002

Note 2.1

31.12.2012

CEN

EN ISO 18113-5:2009

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

7.7.2010

EN 592:2002

Note 2.1

31.12.2012

CEN

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)

21.11.2003

CEN

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)

9.8.2007

Cenelec

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

IEC 61010-2-101:2002 (Modified)

17.12.2002

Cenelec

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

IEC 61326-2-6:2005

27.11.2008

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

IEC 62304:2006

27.11.2008

EN 62304:2006/AC:2008

This is the first publication

Cenelec

EN 62366:2008

Medical devices — Application of usability engineering to medical devices

IEC 62366:2007

27.11.2008

| 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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 (column 3) 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 requirements of the directive. |
| --- | --- |

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 (column 3) 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 requirements of the directive.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3).

2

3

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

—

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

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

—

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

Official Journal of the European Union

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

—

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

Official Journal of the European Union

| — | More information about harmonised standards on the Internet at:
  http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm |
| --- | --- |

—

More information about harmonised standards on the Internet at:

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

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(1)  ESO: European Standards Organisation:

1

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

—

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

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

—

CENELEC: Avenue Marnix 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 204, 21.7.1998, p. 37.

2

(3)  OJ L 217, 5.8.1998, p. 18.

3

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