EN ISO Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process

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1 ÖNORM EN ISO Edition: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (consolidated version) Biologische Beurteilung von Medizinprodukten Teil 1: Beurteilung und Prüfung im Rahmen eines Risikomanagementverfahrens (konsolidierte Fassung) Évaluation biologique des dispositifs médicaux Partie 1: Évaluation et essais au sein d'un processus de gestion du risque (version consolidée) Publisher and printing Austrian Standards Institute/ Österreichisches Normungsinstitut (ON) Heinestraße 38, 1020 Wien Copyright Austrian Standards Institute All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means electronic, mechanical and photocopying or any other data carrier without prior permission! Internet: Sale and distribution of national and foreign standards and technical regulations via Austrian Standards plus GmbH Heinestraße 38, 1020 Wien Internet: Webshop: Tel.: Fax: ICS Identical (IDT) with ISO : Cor 1: Identical (IDT) with EN ISO : AC: Supersedes ÖNORM EN ISO : responsible Committee 179 Medical technology

2 ÖNORM EN ISO :2011 National Foreword The present ÖNORM EN ISO has been reissued without prior public enquiry and represents a consolidated national new edition of EN ISO : , including Corrigendum EN ISO :2009/AC: Following clauses changed: Figure 1: On the left-hand side of the flowchart "1.0" and "7.0" was replaces by "Clause 1" and "Clause 7". On the lower right-hand side of the flowchart, the text in the bottom right rectangle was replaced. 2

3 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO October AC June 2010 ICS Supersedes EN ISO :2009 English version Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfung im Rahmen eines Risikomanagementverfahrens This European Standard was approved by CEN on 17 September This corrigendum becomes effective on 15 June 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 standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the 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 translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of 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, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.. Ref. Nr. EN ISO : AC:2010 E

4 EN ISO : AC:2010 (E) Contents Page Foreword...3 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices...4 Annex ZB (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices...5 2

5 EN ISO : AC:2010 (E) Foreword This document (EN ISO :2009) has been prepared by Technical Committee ISO/TC 194 "Biological evaluation of medical devices" in collaboration with Technical Committee CEN/TC 206 Biological evaluation of medical devices the secretariat of which is held by NEN. 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 2010, and conflicting national standards shall be withdrawn at the latest by April 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 :2009, June. 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 Directives. For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts of this document. 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO :2009 has been approved by CEN as a EN ISO :2009 without any modification. Endorsement notice The text of ISO :2009/Cor 1:2010 has been approved by CEN as a EN ISO :2009/AC:2010 without any modification. 3

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