DIN EN ISO 14602-2012 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602 2010) German version EN ISO 14602 2011《稳定性外科植入物 接骨术植入物 详细要求》.pdf
《DIN EN ISO 14602-2012 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602 2010) German version EN ISO 14602 2011《稳定性外科植入物 接骨术植入物 详细要求》.pdf》由会员分享,可在线阅读,更多相关《DIN EN ISO 14602-2012 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602 2010) German version EN ISO 14602 2011《稳定性外科植入物 接骨术植入物 详细要求》.pdf(21页珍藏版)》请在麦多课文档分享上搜索。
1、June 2012 Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1
2、1.040.40!$|vj“1898371www.din.deDDIN EN ISO 14602Non-active surgical implants Implants for osteosynthesis Particular requirements (ISO 14602:2010)English translation of DIN EN ISO 14602:2012-06Nichtaktive chirurgische Implantate Implantate zur Osteosynthese Besondere Anforderungen (ISO 14602:2010)Eng
3、lische bersetzung von DIN EN ISO 14602:2012-06Implants chirurgicaux non actifs Implants pour ostosynthse Exigences particulires (ISO 14602:2010)Traduction anglaise de DIN EN ISO 14602:2012-06SupersedesDIN EN ISO 14602:2010-08www.beuth.deIn case of doubt, the German-language original shall be conside
4、red authoritative.Document comprises 21 pages05.12 DIN EN ISO 14602:2012-06 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 5 “Osteosynthesis and spinal devices” in collaboration with
5、 Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-02-15 AA Endoprothetik und
6、 Osteosynthese. The DIN Standard corresponding to the International Standard referred to in Clause 2 of this document is as follows: ISO 14630 DIN EN ISO 14630 Amendments This standard differs from DIN EN ISO 14602:2010-08 as follows: a) Annex ZA “Relationship between this European Standard and the
7、Essential Requirements of EU Directive 93/42/EEC” has been updated. Previous editions DIN EN ISO 14602: 1998-08, 2009-08, 2010-08 National Annex NA(informative) Bibliography DIN EN ISO 14630, Non-active surgical implants General requirements EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1
8、4602 October 2011 ICS 11.040.40 Supersedes EN ISO 14602:2010English Version Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) Implants chirurgicaux non actifs - Implants pour ostosynthse - Exigences particulires (ISO 14602:2010)Nichtaktive chirurgi
9、sche Implantate - Implantate zur Osteosynthese - Besondere Anforderungen This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a nationa
10、l standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A versio
11、n in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Cze
12、ch 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. Management Centre: Avenue Marnix 17, B-1000 Brus
13、sels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14602:2011: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG (ISO 14602:2010) Contents Page Foreword . 3 Introductio
14、n . 4 1 Scope . 5 2 Normative references 5 3 Terms and definitions 5 4 Intended performance . 5 4.1 General 5 4.2 Intended purpose . 6 4.3 Functional characteristics . 6 4.4 Intended conditions of use . 7 5 Design attributes 7 6 Materials 8 7 Design evaluation. 8 7.1 General 8 7.2 Pre-clinical evalu
15、ation . 8 7.3 Clinical evaluation 8 7.4 Post-market surveillance . 8 8 Manufacturing . 9 9 Sterilization . 9 10 Packaging . 9 11 Information supplied by manufacturer 9 11.1 General 9 11.2 Labelling 9 11.3 Instructions for use 9 11.4 Restrictions on combinations . 9 11.5 Marking on implant 9 11.6 Mar
16、king for special purposes . 9 Annex A (informative) Correspondence of the clauses of this International Standard to the fundamental principles outlined in ISO/TR 14283 . 10 Annex B (informative) ISO standards referring to implants and associated instruments found acceptable through clinical use for
17、given applications in osteosynthesis 11 Annex C (informative) ISO Standards referring to materials found acceptable through proven clinical use 14 Annex D (informative) Standards related to testing and design evaluation 16 Bibliography 17 Annex ZA (informative) Relationship between this European Sta
18、ndard and the Essential Requirements of EU Directive 93/42/EEC 18 2DIN EN ISO 14602:2012-06 EN ISO 14602:2011 (E) Foreword This document (EN ISO 14602:2011) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ in collaboration with Technical Committee CEN/TC 285 “Non-active sur
19、gical implants” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the latest by April 20
20、12. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14602:2010. This new edition contains a revised An
21、nex ZA. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Acco
22、rding to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, It
23、aly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14602:2010 has been approved by CEN as EN ISO 14602:2011 without any modification. 3DIN EN ISO 14602:20
24、12-06 EN ISO 14602:2011 (E) Introduction In general, non-active surgical implants for osteosynthesis are used in trauma treatment or corrective surgery. They maintain the reduction of fractured bones and stabilize bony (or adjacent) structures to allow bone healing or fusion and/or to provide suppor
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