1、European Standard EN ISO 16054 : 2002 has the status of a DIN Standard.National forewordThis standard has been published in accordance with a decision taken by CEN/TC 285 Non-active surgicalimplants to adopt, without alteration, International Standard ISO 16054 as a European Standard.The responsible
2、 German body involved in its preparation was the Normenausschuss Feinmechanik undOptik (Optics and Precision Mechanics Standards Committee), Technical Committee Chirurgische Implan-tate.DIN EN ISO 8402 and DIN EN ISO 13485 are the standards corresponding to International StandardsISO 8402 and ISO 13
3、485, respectively, referred to in clause 2 of the EN.National Annex NAStandard referred to(and not included in Normative references and Annex ZA)DIN EN ISO 13485 Quality systems Medical devices Particular requirements for the application ofEN ISO 9001 (ISO 13485 : 1996)ICS 11.040.40Chirurgische Impl
4、antate Mindestdatenstze fr chirurgische Implantate (ISO 16054 : 2000)Ref. No. DIN EN ISO 16054 : 2002-09English price group 09 Sales No. 110901.03DEUTSCHE NORM September 2002EN ISO 16054EN comprises 7 pages. No part of this standard may be reproduced without the prior permission ofDIN Deutsches Inst
5、itut fr Normung e.V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).Implants for surgeryMinimum data sets for surgical implants(ISO 16054 : 2000)English version of DIN EN ISO 16054English versionICS 11.040.40Management Centre: rue
6、de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr NormungImplants for surgeryMinimum data sets for surgical implants(ISO 16054 : 2000) 2002. CEN All rights of exploitation in any form and by any meansreserved worldwide for CEN n
7、ational members.Ref. No. EN ISO 16054 : 2002 EImplants chirurgicaux Ensemblesminimaux de donnes relatives auximplants chirurgicaux(ISO 16054 : 2000)Chirurgische Implantate Mindest-datenstze fr chirurgischeImplantate (ISO 16054:2000)This European Standard was approved by CEN on 2002-04-11.CEN members
8、 are bound to comply with the CEN/CENELEC Internal Regulationswhich stipulate the conditions for giving this European Standard the status of anational standard without any alteration.Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to t
9、he Management Centre or to anyCEN member.The European Standards exist in three official versions (English, French, German).A version in any other language made by translation under the responsibility of aCEN member into its own language and notified to the Management Centre hasthe same status as the
10、 official versions.CEN members are the national standards bodies of Austria, Belgium, the CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, Malta, the Netherlands, Norway, Portugal, Spain, Sweden, Switzer-land, and the United Kingdom.May 2002EN ISO 16054Pa
11、ge 2EN ISO 16054 : 2002ForewordInternational StandardISO 16054 : 2000 Implants for surgery Minimum data sets for surgical implants,which was prepared by ISO/TC 150 Implants for surgery, has been adopted by Technical Committee CEN/TC 285 Non-active surgical implants, the Secretariat of which is held
12、by NEN, as a European Standard.This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, and conflicting national standards withdrawn, by November 2002 at the latest.In accordance with the CEN/CENELEC Internal Regulations, t
13、he national standards organizations of the follow-ing countries are bound to implement this European Standard:Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, Malta, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and
14、 the United Kingdom.Endorsement noticeThe text of the International Standard ISO 16054 : 2000 was approved by CEN as a European Standard withoutany modification.NOTE: Normative references to international publications are listed in Annex ZA (normative.)Page 3EN ISO 16054 : 2002Page 4EN ISO 16054 : 2002Page 5EN ISO 16054 : 2002Page 6EN ISO 16054 : 2002Page 7EN ISO 16054 : 2002
