EN ISO 14630:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)Non-active surgical implants - General requirements (ISO 14630:2008)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN ISO 14630:2009SIST EN ISO 14630:2009en01-julij-2009SIST EN ISO 14630:2009SLOVENSKI
STANDARDSIST EN ISO 14630:20081DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14630May 2009ICS 11.040.40Supersedes EN ISO 14630:2008
English VersionNon-active surgical implants - General requirements (ISO14630:2008)Implants chirurgicaux non actifs - Exigences générales(ISO 14630:2008)Nichtaktive chirurgische Implantate - AllgemeineAnforderungen (ISO 14630:2008)This European Standard was approved by CEN on 19 April 2009.CEN members are bound to comply 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 Management 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 theofficial 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, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14630:2009: ESIST EN ISO 14630:2009

Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 SIST EN ISO 14630:2009

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 means 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 the 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 93/42/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 – 5- 7. 1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
Part of ER 1 relating to risk of use error is not addressed by this European Standard.
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - 8.2 - 9.2
7 1 - 2 - 3 - 4 - 6 -6.a - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 -
Part of ER 7.1 relating to the results of biophysical or modelling research is not explicitly addressed by this European Standard.
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2
- 8.1 - 8.3 - 8.4 - 8.5
10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
11 1 - 2 - 8.7 - 13 The part of ER 13.3.a concerning the information on the authorized representative is not addressed in this European Standard
ER: 13.3 f) is only partially addressed: Safety issue is addressed, but not the regulatory requirement (consistency around Europe).
ER: 13.6.h) relating to single use is not addressed by this European Standard.
ER 13.6 q) is not addressed by this European Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 14630:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO14630Third edition2008-01-15Non-active surgical implants — General requirements Implants chirurgicaux non actifs — Exigences générales
ISO 14630:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2008 – All rights reserved
ISO 14630:2008(E) © ISO 2008 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Intended performance.3 5 Design attributes.4 6 Materials.5 7 Design evaluation.5 7.1 General.5 7.2 Pre-clinical evaluation.5 7.3 Clinical evaluation.6 7.4 Post-market surveillance.6 8 Manufacture.6 9 Sterilization.6 9.1 General.6 9.2 Products supplied sterile.6 9.3 Sterilization by the user.7 9.4 Sterilization residuals.7 10 Packaging.7 10.1 Protection from damage in storage and transport.7 10.2 Maintenance of sterility in transit.8 11 Information supplied by the manufacturer.8 11.1 General.8 11.2 Labelling.9 11.3 Instructions for use.9 11.4 Restrictions on combinations.11 11.5 Marking on implants.11 11.6 Marking for special purposes.11 Annex A (informative)
Correspondence between this International Standard and ISO/TR 14283:2004.12 Bibliography.13
ISO 14630:2008(E) iv © ISO 2008 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14630 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This third edition cancels and replaces the second edition (ISO 14630:2005), which has been technically revised. SIST EN ISO 14630:2009

ISO 14630:2008(E) © ISO 2008 – All rights r
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