Directive 98/79/EC. Commission communication in relation to Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 280 page 11 of
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1 Directive 98/79/EC Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( OJ No L 331/1) EC Contact Point DG Enterprise - G.4 Mr. Antonio Lacerda De Queiroz / Hannu Seitsonen Tel / , Fax entr-medical-devices@cec.eu.int Web site at Publications in the Official Journal Only the publications from, and 2003 are listed hereunder. You can access the 1998, 1999 and publications on devices OJ C 280 page 11 of Corrigendum to Commission communication (page 9 of OJ )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 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 devices OJ C 314 page 8 of devices OJ C 314 page 9 of Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 182 page 8 of Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 182 pages 9-10 of Important notice: EN 12180: devices OJ C 319 page 9 of Directive 98/79/EC on in-vitro diagnostic medical devices OJ C 319 page 13 of Summary list of titles and references of harmonised standards related to in vitro diagnostic medical devices: 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.
2 European Standards Bodies Standard reference EN 375: EN 376: EN 455-1: EN 455-2: EN 552: 1994/ A2: EN 556-1: EN 591: EN 592: EN 794-1: 1997/ A1: EN 928: 1995 EN 980: 1996/ A1:1999 EN 980: 1996/ A2: EN : 1997/ A1: Titles Information supplied by the manufacturer with in vitro diagnostic reagents for professional use Information supplied by the manufacturer with in vitro diagnostic reagents for selftesting Medical gloves for single use - Part 1: Requirements and testing for freedom from holes Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Corrigendum 1996) Sterilisation of medical devices - Validation and routine control of sterilisation by irradiation Sterilisation of medical devices - Requirements for medical devices to be designated 'Sterile' - Part 1: Requirements for terminally sterilised medical devices Instructions for use in vitro diagnostic instruments for professional use Instructions for use for in vitro diagnostic instruments for self-testing Lung ventilators - Part 1: Particular requirements for critical care ventilators In vitro diagnostic systems - Guidance on the application of EN and EN and of EN and EN for in vitro diagnostic medical devices Graphical symbols for use in the labelling of medical devices Graphical symbols for use in the labelling of medical devices Agent specific filling systems for anaesthetic vaporisers - Part 1: Rectangular keyed filling systems Reference of the superseded standard Publication OJ
3 EN 1658: : 4135: : : : : EN 12180: EN 12286: 1998 EN 12286: 1998/ A1: EN 12287: 1999 EN 12322: 1999 Requirements for marking of in vitro diagnostic instruments Natural latex rubber condoms - Requirements and test methods (ISO 4074:) Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:) 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 :) Part 8: Selection and qualification of reference materials for biological tests (ISO :) Part 14: Identification and quantification of degradation products from ceramics (ISO :) Part 15: Identification and quantification of degradation products from metals and alloys (ISO :) Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants Important notice: The references of EN 12180:, published on page 10 of OJ, will be deleted in an "Official Journal Corrigendum" in April biological origin - Presentation of reference measurement procedures biological origin - Presentation of reference measurement procedures biological origin - Description of reference materials Culture media for microbiology - Performance criteria for culture media C 293 of C 288 of
4 EN 12322: 1999/ A1: EN 12718: corrigendum ENV 12719: corrigendum EN : EN 13485: EN 13488: EN 13532: EN : EN : EN 13612: EN 13640: EN 13641: EN 13975:2003 Culture media for microbiology - Performance criteria for culture media Corrigendum to page 9 of : the references to EN 12718: are deleted in OJ C 273 of Corrigendum to page 9 of : the references to EN 12718: are deleted in OJ C 273 of Breathing system filters for anaesthetic and respiratory use - Part 1: Test method to assess filtration performance Quality systems - Medical devices - Particular requirements for the application of 9001:1994 (revision of EN 46001:1996) EN standard EN 46001: (Note 1) Quality systems - Medical devices - Particular requirements for the application of 9002:1994 (revision of EN :1996) EN standard EN 46002: (Note 1) General requirements for in vitro diagnostic medical devices for self-testing Respiratory therapy equipment - Part 1: Nebulising systems and their components Respiratory therapy equipment - Part 3: Air entrainment devices Performance evaluation of in vitro diagnostic medical devices Stability testing of in vitro diagnostic medical devices Elimination or reduction of risk of infection related to in vitro diagnostic reagents Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects C 280 of
5 14937: 14971: 18153: : ELEC EN : 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:) Medical devices - Application of risk management to medical devices (ISO 14971:) EN 1441 standard: (Note 1) Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment None C 280 of Reference document: IEC : (Modified) 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.
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