欧盟体外诊断器械IVDD98/79/EC相关标准 - 体外诊断注册标准源兴医疗

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ESO (1)	Reference and title of the harmonised standard (and reference document)	First publication OJ	Reference of superseded standard	Date of cessation of presumption of conformity of superseded standard Note 1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)
CEN	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
CEN	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)
CEN	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
CEN	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
CEN	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
Cenelec	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.