1、 Reference numberISO/TS 11135-2:2008(E)ISO 2008TECHNICAL SPECIFICATION ISO/TS11135-2First edition2008-08-01Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 Strilisation des produits de sant Oxyde dthylne Partie 2: Directives relatives lapplicati
2、on de lISO 11135-1 National Standard of CanadaCAN/CSA-Z11135-2-09(ISO/TS 11135-2:2008)Technical Specification ISO/TS 11135-2:2008 (first edition, 2008-08-01) has been adopted withoutmodification (IDT) as CSA Standard CAN/CSA-Z11135-2-09, which has been approved as a National Standardof Canada by the
3、 Standards Council of Canada.ISBN 978-1-55491-079-3 March 2009 International Organization for Standardization (ISO), 2008. All rights reserved.NOT FOR RESALE. Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process appr
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34、ian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in March 2009 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online
35、 Store at www.ShopCSA.caCAN/CSA-Z11135-2-09Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1Registered trade-mark of Canadian Standards AssociationReviewed byPrepared byInternational Organization for StandardizationCAN/CSA-Z11135-2-09Sterilizatio
36、n of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1March 2009 Canadian Standards Association CSA/3CAN/CSA-Z11135-2-09Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1CSA PrefaceThis is the first edition of
37、CAN/CSA-Z11135-2, Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 11135-2 (first edition, 2008-08-
38、01). This Standard 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 Standa
39、rd of Canada by the Standards Council of Canada.March 2009 Canadian Standards Association 2009All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this Tech
40、nical Specification” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-
41、4000www.csa.caTo 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.Reference numberISO/TS 11135-2:2008(E)ISO 2008TECHNICAL SPECIFICATION ISO/TS11135-2First edition2008-08-01Sterilization of health care products
42、 Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 Strilisation des produits de sant Oxyde dthylne Partie 2: Directives relatives lapplication de lISO 11135-1 ISO/TS 11135-2:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing polic
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45、 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 2008 All rights reserved. Unless otherwise specified, no part of this publi
46、cation 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 member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Genev
47、a 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ii ISO 2008 All rights reservedCAN/CSA-Z11135-2-09ISO/TS 11135-2:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions.
48、2 4 Quality management systems . 2 4.1 Documentation 2 4.2 Management responsibility . 2 4.3 Product realization 3 4.4 Measurement, analysis and improvement Control of non-conforming product . 3 5 Sterilizing agent characterization . 3 5.1 Sterilizing agent 3 5.2 Microbicidal effectiveness . 3 5.3 M
49、aterials effects 3 5.4 Environmental considerations 3 6 Process and equipment characterization 4 6.1 Process characterization . 4 6.2 Equipment characterization. 4 7 Product definition . 5 7.1 General. 5 7.2 Product safety and performance. 8 7.3 Microbiological quality. 9 7.4 Documentation 9 8 Process definition. 9 9 Validation. 12 9.1 Installation qualification. 13 9.2 Operational qualification 14 9.3 Performance qualification 15 9.4 Varying load configurations 19 9.5 Review and approval of validatio
