CAN CSA-Z17665-2009 Sterilization of health care products - Moist heat - Part 2 Guidance on the application of ISO 17665-1 (First Edition).pdf

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1、Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1CAN/CSA-Z17665-2-09(ISO/TS 17665-2:2009, IDT)National Standard of CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Legal Notice for StandardsCanadian Standards Association (CSA) standards are de

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35、4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caPrepared byInternational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-Z17665-2-09Sterilization of health care products Moist heat Part 2: Guidanceon the application of ISO 17665-1CAN/CSA-Z17665-

36、2-09Sterilization of health care products Moist heat Part 2: Guidanceon the application of ISO 17665-1CSA/4 Canadian Standards Association November 2009CAN/CSA-Z17665-2-09Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO17665-1CSA PrefaceThis is the first ed

37、ition of CAN/CSA-Z17665-2, Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 17665-2 (first edition, 200

38、9-01-15).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 St

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43、hange.Reference numberISO/TS 17665-2:2009(E)ISO 2009TECHNICAL SPECIFICATION ISO/TS17665-2First edition2009-01-15Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1 Strilisation des produits de sant Chaleur humide Partie 2: Directives relatives lapplica

44、tion de lISO 17665-1 International Organization for Standardization (ISO), 2009. All rights reserved. NOT FOR RESALE.ISO/TS 17665-2:2009(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 edi

45、ted 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 Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a t

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47、dies. 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

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49、opyrightiso.org Web www.iso.org ii ISO 2009 All rights reservedCAN/CSA-Z17665-2-09ISO/TS 17665-2:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Quality management system elements 2 5 Sterilizing agent characterization . 2 5.1 Sterilizing agent 2 5.2 Microbicidal effectiveness . 2 5.3 Material effects 3 5.4 Environmental considerations 3 6 Process and equipment characterization 3 6.1 Proce