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欧盟体外诊断器械IVDD98/79/EC相关标准
  [  2015-01-06 11:27 ]

欧盟体外诊断器械IVDD98/79/EC相关标准

The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.
Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.

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Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard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

31/07/2002

EN 556:1994 + A1:1998

Note 2.1

Date expired
(30/04/2002)

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

09/08/2007

 

 

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

23/07/2008

EN 980:2003

Note 2.1

Date expired
(31/05/2010)

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)

07/07/2010

 

 

CEN

EN 12322:1999

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

09/10/1999

 

 

EN 12322:1999/A1:2001

 

31/07/2002

Note 3

Date expired
(30/04/2002)

CEN

EN ISO 13485:2003

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

02/04/2004

EN ISO 13488:2000
EN ISO 13485:2000


Note 2.1

Date expired
(31/07/2009)

EN ISO 13485:2003/AC:2009

 

07/07/2010

 

 

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

 

02/12/2009

 

 

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

28/04/2005

 

 

CEN

EN 14820:2004

Single-use containers for human venous blood specimen collection

28/04/2005

 

 

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)

07/07/2010

EN ISO 14937:2000

Note 2.1

Date expired
(30/04/2010)

CEN

EN ISO 14971:2009

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

07/07/2010

EN ISO 14971:2007

Note 2.1

Date expired
(21/03/2010)

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)

07/07/2010

 

 

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)

07/07/2010

 

 

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)

28/04/2005

 

 

EN ISO 15197:2003/AC:2005

 

02/12/2009

 

 

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)

28/04/2005

 

 

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)

07/07/2010

 

 

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)

07/07/2010

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)

07/07/2010

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)

07/07/2010

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)

07/07/2010

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)

09/08/2007

 

 

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 (new)

 

This is the first publication

 

 

Cenelec

EN 62366:2008

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

27/11/2008

 

 

 

(1) ESO: European Standardisation Organisation:

CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.org)

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

 

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 2.2: 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 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.


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