Commission communication in relation to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 280 page 11 of 2003-11-21
Corrigendum to Commission communication (page 9 of OJ C 182 of 2002-07-31)in relation to Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices OJ C 273 page 11 of 2003-11-14
Commission communication in relation to Directive 93/42/EEC on medical devices, Directive 98/79/EC on in-vitro diagnostic medical devices and Directive 90/385/EEC on active implantable medical devices OJ C 32 page 14 of 2003-02-11
Commission communication in relation to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 314 page 8 of 2002-12-17
Commission communication in relation to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 314 page 9 of 2002-12-17
Commission communication in relation to Directive 93/42/EEC on medical devices and to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 182 page 8 of 2002-07-31
Commission communication in relation to Directive 93/42/EEC on medical devices and to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 182 pages 9-10 of 2002-07-31
Important notice: EN 12180:2000
Commission communication in relation to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 319 page 9 of 2001-11-14
Commission communication in relation to Directive 93/42/EEC on medical devices and to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 319 page 13 of 2001-11-14
The information contained in the summary list is a compilation of the references of standards which have been published 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 produces legal affect.
European
Standards
Bodies |
Standard reference |
Titles |
Reference of the superseded standard |
Publication OJ |
CEN |
EN 375: 2001 |
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use |
|
C 182 of 2002-07-31 |
CEN |
EN 376: 2002 |
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing |
|
C 182 of 2002-07-31 |
CEN |
EN 455-1: 2000 |
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
|
C 319 of 2001-11-14 |
CEN |
EN 455-2: 2000 |
Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Corrigendum 1996) |
|
C 182 of 2002-07-31 |
CEN |
EN 552: 1994/ A2:2000 |
Sterilisation of medical devices - Validation and routine control of sterilisation by irradiation |
|
C 182 of 2002-07-31 |
CEN |
EN 556-1: 2001 |
Sterilisation of medical devices - Requirements for medical devices to be designated 'Sterile' - Part 1: Requirements for terminally sterilised medical devices |
|
C 182 of 2002-07-31 |
CEN |
EN 591: 2001 |
Instructions for use in vitro diagnostic instruments for professional use |
|
C 182 of 2002-07-31 |
CEN |
EN 592: 2002 |
Instructions for use for in vitro diagnostic instruments for self-testing |
|
C 182 of 2002-07-31 |
CEN |
EN 794-1: 1997/ A1:2000 |
Lung ventilators - Part 1: Particular requirements for critical care ventilators |
|
C 182 of 2002-07-31 |
CEN |
EN 928: 1995 |
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices |
|
C 227 of 1999-08-10 |
CEN |
EN 980: 1996/ A1:1999 |
Graphical symbols for use in the labelling of medical devices |
|
C 319 of 2001-11-14 |
CEN |
EN 980: 1996/ A2:2001 |
Graphical symbols for use in the labelling of medical devices |
|
C 182 of 2002-07-31 |
CEN |
EN 1280-1: 1997/ A1:2000 |
Agent specific filling systems for anaesthetic vaporisers - Part 1: Rectangular keyed filling systems |
|
C 182 of 2002-07-31 |
CEN |
EN 1658: 1996 |
Requirements for marking of in vitro diagnostic instruments |
|
C 227 of 1999-08-10 |
CEN |
EN ISO 4074: 2002 |
Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 4135: 2001 |
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 9360-1: 2000 |
Anaesthesic and respiratory equipment - Heat and moisture exhangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
|
C 319 of 2001-11-14 |
CEN |
EN ISO 10993-8: 2001 |
Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 10993-14: 2001 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 10993-15: 2000 |
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
|
C 319 of 2001-11-14 |
CEN |
EN 12180: 2000 |
Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants |
|
C 182 of 2002-07-31 |
Important notice : The references of EN 12180:2000, published on page 10 of OJ C 182 of 2002-07-31, will be deleted in an "Official Journal Corrigendum" in April 2003. |
CEN |
EN 12286: 1998 |
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures |
|
C 227 of 1999-08-10 |
CEN |
EN 12286: 1998/ A1:2000 |
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures |
|
C 319 of 2001-11-14 |
CEN |
EN 12287: 1999 |
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials |
|
C 293 of 2000-10-14 |
CEN |
EN 12322: 1999 |
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
|
C 288 of 1999-10-09 |
CEN |
EN 12322: 1999/ A1:2001 |
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
|
C 182 of 2002-07-31 |
CEN |
EN 12718: 2001
corrigendum |
Corrigendum to page 9 of C 182 of 2002-07-31:
the references to EN 12718:2001 are deleted in OJ C 273 of 2003-11-14 |
CEN |
ENV 12719: 2001
corrigendum |
Corrigendum to page 9 of C 182 of 2002-07-31:
the references to EN 12718:2001 are deleted in OJ C 273 of 2003-11-14 |
CEN |
EN 13328-1: 2001 |
Breathing system filters for anaesthetic and respiratory use - Part 1: Test method to assess filtration performance |
|
C 182 of 2002-07-31 |
CEN |
EN 13485:
2000 |
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001:1994 (revision of EN 46001:1996) |
EN 46001 |
C 182 of 2002-07-31 |
Date of cessation of presumption of conformity of the superseded standard EN 46001:
2004-03-01 ( Note 1 ) |
CEN |
EN 13488:
2000 |
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002:1994 (revision of EN 46002 :1996) |
EN 46002 |
C 182 of 2002-07-31 |
Date of cessation of presumption of conformity of the superseded standard EN 46002:
2004-03-01 ( Note 1 ) |
CEN |
EN 13532: 2002 |
General requirements for in vitro diagnostic medical devices for self-testing |
|
C 314 of 2002-12-17 |
CEN |
EN 13544-1: 2001 |
Respiratory therapy equipment - Part 1: Nebulising systems and their components |
|
C 182 of 2002-07-31 |
CEN |
EN 13544-3: 2001 |
Respiratory therapy equipment - Part 3: Air entrainment devices |
|
C 182 of 2002-07-31 |
CEN |
EN 13612: 2002 |
Performance evaluation of in vitro diagnostic medical devices |
|
C 314 of 2002-12-17 |
CEN |
EN 13640: 2002 |
Stability testing of in vitro diagnostic medical devices |
|
C 314 of 2002-12-17 |
CEN |
EN 13641: 2002 |
Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
|
C 314 of 2002-12-17 |
CEN |
EN 13975:2003 |
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
|
C 280 of 2003-11-21 |
CEN |
EN ISO 14937: 2000 |
Sterilisation of health care products - General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000) |
|
C 182 of 2002-07-31 |
CEN |
EN ISO 14971:
2000 |
Medical devices - Application of risk management to medical devices (ISO 14971:2000) |
EN 1441 |
C 182 of 2002-07-31 |
Date of cessation of presumption of conformity of the superseded standard:
2004-04-01 ( Note 1 ) |
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) |
|
C 280 of 2003-11-21 |
CEN |
EN ISO 15225: 2000 |
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) |
|
C 182 of 2002-07-31 |
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
Reference document:
IEC 61010-2-101:2002 (Modified) |
None |
|
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.
