《EN 1041-2016医疗器械厂商提供的信息》.doc

Information supplied by the manufacturer of medical devices 医疗器械厂商提供的信息 ICS 01.110; 11.040.01; 11.120.01  EUROPEAN STANDARD EN 1041 NORME EUROPéENNE EUROP?ISCHE NORM August 2008 ICS 01.110; 11.040.01; 11.120.01 Supersedes EN 1041:1998 English version Information supplied by the manufacturer of medical devices 医疗器械厂商提供的信息 Informations fournies par le fabricant de dispositifs Bereitstellung von Informationen durch den Hersteller von médicaux Medizinprodukten This European Standard was approved by CEN on 4 July 2008. CEN andCENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and/or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat: rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels ? 2008 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN 1041:2008 E worldwide for CEN national Members and for CENELEC Members. BS EN 1041:2008 EN 1041:2008 (E) Contents Page Foreword 3 Introduction 4 1 Scope 5 2 Nor