CAN CSA-ISO 14937-2011 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of.pdf

1、Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesCAN/CSA-ISO 14937:11(ISO 14937:2009, IDT)National Standard of CanadaNOT FOR RESALE.PUBLICATION NON

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18、 you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.CSA Standards Update ServiceCAN/CSA-ISO 14937:11October 2011Title:Sterilization of health care products General requirem ents for characterization of a ste

19、rilizing agent and the development, validation and routine control of a sterilization process for medical devicesPagination:48 pages (CSA/1CSA/4, ivii, and 37 text)To register for e-mail notification about any updates to this publicationgo to www.ShopCSA.caclick on E-mail Services under MY ACCOUNTcl

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36、 Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caPrepared byInternational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-ISO 14937:11Sterilization of health care products General requirements for characterization of a sterilizing agent

37、and the development, validation and routine control of a sterilization process for medical devicesCAN/CSA-ISO 14937:11Sterilization of health care products General requirements forcharacterization of a sterilizing agent and the development, validationand routine control of a sterilization process fo

38、r medical devicesCSA/4 Canadian Standards Association October 2011CAN/CSA-ISO 14937:11Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of asterilization process for medical devicesCSA PrefaceThi

39、s is the second edition of CAN/CSA-ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices, which is an adoption without modification of the id

40、entically titled ISO (International Organization for Standardization) Standard 14937 (second edition, 2009-10-15). It supersedes the previous edition published in 2001 as CAN/CSA-ISO 14937 (adopted ISO 14937:2000).This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Ste

41、rilization, under the jurisdiction of the CSA 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 the Standards Council of Canada.October 2011 Canadian Standards Associa

42、tion 2011All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of thepublisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be interpreted as “this National S

43、tandard 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 416-747-4000www.csa.caTo purchase CSA Standards and related publications, visit CSAs Online Sto

44、re at www.ShopCSA.ca or call toll-free 1-800-463-6727 or 416-747-4044.CSA Standards are subject to periodic review, and suggestions for their improvement will be referred to the appropriate committee. To submit a proposal for change to CSA Standards, please send the following information to inquirie

45、scsa.ca and include “Proposal for change” in the subject line:(a) Standard designation (number);(b) relevant clause, table, and/or figure number;(c) wording of the proposed change; and(d) rationale for the change.Reference numberISO 14937:2009(E)ISO 2009INTERNATIONAL STANDARD ISO14937Second edition2

46、009-10-15Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Strilisation des produits de sant Exigences gnrales pour la caractrisation dun agent stri

47、lisant et pour la mise au point, la validation et la vrification de routine dun processus de strilisation pour dispositifs mdicaux ISO 14937:2009(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 n

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