1、 Reference numberISO 11137-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11137-1First edition2006-04-15Sterilization of health care products Radiation Part 1: Requirements for development, validationand routine control of a sterilization process for medical devices Strilisation des produits de sant Irr
2、adiation Partie 1: Exigences relatives la mise au point, la validation et au contrle de routine dun procd de strilisation pour les dispositifs mdicaux National Standard of CanadaCAN/CSA-Z11137-1-07(ISO 11137-1:2006)International Standard ISO 11137-1:2006 (first edition, 2006-04-15) has bee n adopted
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34、 for their particular purpose.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in March 2007 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontari
35、o, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z11137-1-07Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesPrepared byInternational Organizat
36、ion for StandardizationRegistered trade-mark of Canadian Standards AssociationReviewed byCAN/CSA-Z11137-1-07Sterilization of health care products Radiation Part 1: Requirements for development, validation androutine control of a sterilization process for medical devicesMarch 2007 Canadian Standards
37、Association CSA/3CAN/CSA-Z11137-1-07Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesCSA PrefaceThis is the first edition of CAN/CSA-Z11137-1, Sterilization of health care products Radia
38、tion Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-1 (first edition, 2006-04-15). This Standa
39、rd was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by
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42、purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free 1-800-463-6727 or 416-747-4044.Blank pageReference numberISO 11137-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11137-1First edition2006-04-15Sterilization of health care products Radiation Par
43、t 1: Requirements for development, validationand routine control of a sterilization process for medical devices Strilisation des produits de sant Irradiation Partie 1: Exigences relatives la mise au point, la validation et au contrle de routine dun procd de strilisation pour les dispositifs mdicaux
44、ISO 11137-1:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes 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 dow
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47、 given below. ISO 2006 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 ISOs me
48、mber body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ii ISO 2006 All rights reservedISO 11137-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduc
49、tion v 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Quality management system elements 8 4.1 Documentation 8 4.2 Management responsibility . 9 4.3 Product realization 9 4.4 Measurement, analysis and improvement Control of nonconforming product 9 5 Sterilizing agent characterization . 9 5.1 Sterilizing agent 9 5.2 Microbicidal effectiveness . 9 5.3 Material effects 9 5.4 Environmental considerations 10 6 Process
