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Reference of superseded standard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Date of cessation of presumption of conformity of superseded standard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.
