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欧盟体外诊断器械指令IVDD9879EC相关标准

阅读: 2017年02月20日

  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 

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Reference of   superseded standard

Date of   cessation of presumption of conformity of superseded standard 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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