医疗器械协调标准清单.doc

HYPERLINK http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/index_en.htm \o List of references of harmonised standards List of references of harmonised standards of Medical devices Directive 93/42/EEC Short name: Medical devices Base: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(OJ No L 169/1 of 1993-07-12) Modification: [-] Directive repealed as from 1.1.1995: 76/764/EEC Application Guide: Guidelines relating to the demarcation between Directives 90/385/EEC, 93/42/EEC and 65/65/EECGuidelines on a Medical Devices Vigilance System EC contact point: DG Enterprise Industry Mr. M. KOHLERTel. +32 2 296 75 83Fax. +32 2 296.70.13 HYPERLINK mailto:Entr-cosm-med-dev@ec.europa.eu \o entr-cosm-med-dev@ec.europa.eu \t _blank entr-cosm-med-dev@ec.europa.eu Website of Active Implantable HYPERLINK http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm \o Medical Devices \t _blank Medical Devices Publications in the Official Journal: I n relation to Council Directive 93/42/EEC on medical devicesOJ C 293 of 2009-12-02 This list replaces all the previous lists published in the Official Journal of the European Union. Summary list of titles and references of harmonised standards in relation to 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 lists are updated regularly, they may not be complete and they do not have any legal validity; only publication in the Official Journal produces legal affect. ESO HYPERLINK http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm \l (1)#(1) \o (1) (1) Reference and title of the harmonised standard(and reference document) First publication OJ HYPERLINK http://ec.europa.eu/enterprise/p