BS EN ISO 14602-2011 Non-active surgical implants Implants for osteosynthesis Particular requirements《稳定性外科植入物 接骨术植入物 详细要求》.pdf
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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14602:2011Non-active surgical implants Implants for osteosynthesisParticular requirements (ISO 14602:2010)BS EN ISO 14602:2011 BRITISH STANDARDNational forewordThis Bri
2、tish Standard is the UK implementation of EN ISO14602:2011. It is identical to ISO 14602:2010. It supersedes BS EN ISO14602:2010 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/5, Surgical Implants - Osteosynthesis and spinaldevices.A list of org
3、anizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 76946 7ICS 11.040.40Compliance with a British Standard
4、cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14602 October 2011 ICS 1
5、1.040.40 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 chirurgische Implantate - Impla
6、ntate zur Osteosynthese - Besondere Anforderungen (ISO 14602:2010) 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 national stan
7、dard 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 version in a
8、ny 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, Czech Rep
9、ublic, 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. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN D
10、E NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 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: EBS EN ISO 14602:2011EN ISO 14602:2011 (E) 3 Foreword This doc
11、ument (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 surgical implants” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, e
12、ither 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 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/o
13、r 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 Annex ZA. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associa
14、tion, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impleme
15、nt this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Switz
16、erland 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. BS EN ISO 14602:2011EN ISO 14602:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Dir
17、ective 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices as amended by Directive 2007
18、/47/EC. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standa
19、rd, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between Directive 93/42/EEC and this European Standard Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directiv
20、e 93/42/EEC Qualifying remarks/Notes 5, 7, 8 and 10 7.2 6 7.3 5 7.5 1stsentence 5 and 6 7.6 10 8.3 9 8.4 9 8.5 10 8.6 11.2 8.7 11.4 9.1 5 and 6 9.2 2ndindent 11.1 13.2 11.2 13.3 a) 1stsentence 11.2 13.3 b) 11.2 13.3 c) 11.2 13.3 d) 11.2 13.3 e) 11.2 13.3 f) 11.6 13.3 g) 11.6 13.3 h) 10 and 11.2 13.3
21、 i) 11.2 13.3 j) BS EN ISO 14602:2011EN ISO 14602:2011 (E) 5 Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 11.2 13.3 k) 11.2 13.3 m) 11.2 and 11.3 13.4 4.3 13.5 11.3 13.6 a)11.3 and 11.4 13.6 c) 11.3 13.6 e)9 13.6 g)9 1
22、3.6 i) 11.3 b) 13.6 k) 11.3 13.6 n)11.3 b) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 14602:2011ISO 14602:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1
23、 2 Normative references1 3 Terms and definitions .1 4 Intended performance.1 4.1 General .1 4.2 Intended purpose 2 4.3 Functional characteristics2 4.4 Intended conditions of use.3 5 Design attributes .3 6 Materials .4 7 Design evaluation4 7.1 General .4 7.2 Pre-clinical evaluation.4 7.3 Clinical eva
24、luation .4 7.4 Post-market surveillance4 8 Manufacturing5 9 Sterilization 5 10 Packaging.5 11 Information supplied by manufacturer5 11.1 General .5 11.2 Labelling.5 11.3 Instructions for use .5 11.4 Restrictions on combinations5 11.5 Marking on implant5 11.6 Marking for special purposes 5 Annex A (i
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