Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO (ISO :2009)

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1 Standard Recommendation S.R. CEN ISO/TS :2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO (ISO :2009) NSAI 2009 No copying without NSAI permission except as permitted by copyright law.

2 This document was published under the authority of the NSAI and comes into effect on: 23 February, 2009 CEN ISO/TS : January, 2009 ICS number: Swift Square, Northwood, Santry Dublin 9 T F E W T F W standards.ie Údarás um Chaighdeáin Náisiúnta na héireann

3 TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION IS CEN ISO/TS :2009 CEN ISO/TS January 2009 ICS English Version Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO (ISO :2009) Stérilisation des produits de santé - Chaleur humide - Partie 2: Directives relatives à l'application de l'iso (ISO :2009) Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 2: Leitfaden für die Anwendung von ISO (ISO :2009) This Technical Specification (CEN/TS) was approved by CEN on 23 November 2008 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. 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 STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS :2009: E

4 CEN ISO/TS :2009 (E) IS CEN ISO/TS :2009 Contents Page Foreword...3 2

5 IS CEN ISO/TS :2009 CEN ISO/TS :2009 (E) Foreword This document (CEN ISO/TS :2009) has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" of the International Organization for Standardization (ISO) and has been taken over as CEN/TS ISO :2009 by Technical Committee CEN/TC 204 Sterilization of medical devices the secretariat of which is held by BSI. 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: 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 CEN/TS ISO :2009 without any modification. 3

6

7 IS CEN ISO/TS :2009 TECHNICAL SPECIFICATION ISO/TS First edition Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO Stérilisation des produits de santé Chaleur humide Partie 2: Directives relatives à l'application de l'iso Reference number ISO/TS :2009(E) ISO 2009

8 ISO/TS :2009(E) IS CEN ISO/TS :2009 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. COPYRIGHT PROTECTED DOCUMENT ISO 2009 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 Fax Web Published in Switzerland ii ISO 2009 All rights reserved

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