|
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Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard
|
| 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 62366:2008
Medical devices - Application of usability engineering to medical devices
IEC 62366:2007
|
27/11/2008 |
|
|
| CEN |
EN 375:2001
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
|
31/07/2002 |
|
|
| CEN |
EN 376:2002
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
|
31/07/2002 |
|
|
| 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 591:2001
Instructions for use for in vitro diagnostic instruments for professional use
|
31/07/2002 |
|
|
| CEN |
EN 592:2002
Instructions for use for in vitro diagnostic instruments for self-testing
|
31/07/2002 |
|
|
| CEN |
EN 980:2008
Symbols for use in the labelling of medical devices
|
23/07/2008 |
EN 980:2003
Note 2.1 |
31/05/2010 |
| CEN |
EN 12286:1998
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
|
10/08/1999 |
|
|
| |
EN 12286:1998/A1:2000 |
14/11/2001 |
Note 3 |
Date expired
(24/11/2000) |
| CEN |
EN 12287:1999
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
|
14/10/2000 |
|
|
| 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 |
31/07/2009 |
| |
EN ISO 13485:2003/AC:2007 |
09/08/2007 |
|
|
| 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 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 14937:2000
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 14937:2000)
|
31/07/2002 |
|
|
| CEN |
EN ISO 14971:2007
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
|
09/08/2007 |
EN ISO 14971:2000
Note 2.1 |
31/03/2010 |
| 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 15225:2000
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)
|
31/07/2002 |
|
|
| 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 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 |
|
