EN ISO 14607-2009 en Non-active surgical implants - Mammary implants - Particular requirements《非活性外科植入物 乳房植入物 特殊要求》.pdf
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1、BS EN ISO 14607:2009ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDNon-active surgical implants Mammary implants Particular requirementsThis British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November
2、 2009. BSI 2009ISBN 978 0 580 68133 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 14607:2009National forewordThis British Standard is the UK implementation of EN ISO 14607:2009.It is identical to ISO 14607:2007. It supersedes BS EN ISO 14607:2007which is withdrawn.The UK part
3、icipation in its preparation was entrusted to TechnicalCommittee CH/150, Implants for surgery.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible
4、 for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14607May 2009ICS 11.040.40 Supersedes EN ISO 14607:2007 English VersionNon-active surgical implants - Mammary implants - Particularrequir
5、ements (ISO 14607:2007)Implants chirurgicaux non actifs - Implants mammaires -Exigences particulires (ISO 14607:2007)Nichtaktive chirurgische Implantate - Mammaimplantate -Besondere Anforderungen (ISO 14607:2007)This European Standard was approved by CEN on 19 April 2009.CEN members are bound to com
6、ply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Manageme
7、nt Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theoff
8、icial versions.CEN members are the national standards bodies 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, Slov
9、enia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN nation
10、al Members.Ref. No. EN ISO 14607:2009: EBS EN ISO 14607:2009EN ISO 14607:2009 (E) 3 Foreword The text of ISO 14607:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14607:2009
11、by 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, either by publication of an identical text or by endorsement, at the latest by November 2009, and conflicting national st
12、andards shall be withdrawn at the latest by March 2010. 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 IS
13、O 14607:2007. 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 EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document
14、. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy
15、, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14607:2007 has been approved by CEN as a EN ISO 14607:2009 without any modification. BS EN ISO 14607:2009E
16、N ISO 14607:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 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 mea
17、ns of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with th
18、e clauses of this standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA Correspondence between this European Standard and Directive 93/
19、42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1 - 2 - 3 - 4 - 7.1 5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - 8.2 - 9.2 7 1 - 2 - 3 - 4 - 5 - 6 - 6.a - 7.1 - 7.2 -
20、 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 8 1 - 2 - 3 - 5 - 7.1 - 7.2 9 1 - 2 - 7.2 - 8.1 - 8.3 - 8.4 10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6 11 1 - 2 - 13 Subclause 11.7 requires that the information detailed in Annex F be given to the patient by the medical staff, in accordance with the Essential Requirements 1
21、3.6 k) and l). The part of ER 13.3.a concerning the information on the authorized representative is not addressed in this European Standard ER 13.6.q) This relevant Essential Requirement is not addressed in this European Standard. WARNING Other requirements and other EU Directives may be applicable
22、to the product(s) falling within the scope of this standard. BS EN ISO 14607:2009ISO 14607:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Intended performance 2 5 Design attributes. 2 6 Materials 3
23、7 Design evaluation . 3 7.1 General. 3 7.2 Pre-clinical evaluation 3 7.3 Clinical evaluation 6 7.4 Post-market surveillance . 7 8 Manufacturing . 7 9 Sterilization 7 10 Packaging 7 11 Information supplied by the manufacturer 7 11.1 General. 7 11.2 Resterilization . 8 11.3 Base dimensions 8 11.4 Effe
24、cts on diagnostic techniques . 8 11.5 Filling materials. 8 11.6 Information on expected lifetime 8 11.7 Information for the patient . 8 11.8 Labels. 9 11.9 Information for the user . 9 11.10 Marking on implants. 9 11.11 Manufacturers device card . 9 Annex A (normative) Test for surface characteristi
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