CAN CSA-Z11140-2007 Sterilization of health care products - Chemical indicators - Part 1 General requirements (Second Edition).pdf

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1、 Reference numberISO 11140-1:2005(E)ISO 2005INTERNATIONAL STANDARD ISO11140-1Second edition2005-07-15Sterilization of health care products Chemical indicators Part 1: General requirements Strilisation des produits de sant Indicateurs chimiques Partie 1: Exigences gnrales National Standard of CanadaC

2、AN/CSA-Z11140-1-07(ISO 11140-1:2005)International Standard ISO 11140-1:2005 (second edition, 2005-07-15) has been adopted withoutmodification (IDT) as CSA Standard CAN/CSA-Z11140-1-07, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-55436-445-0 March

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34、anadian 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 Store at www.ShopCSA.caCAN/CSA-Z11140-1-07Sterilization of health care products Chemical indicators Part 1: General r

35、equirementsPrepared byInternational Organization for StandardizationRegistered trade-mark of Canadian Standards AssociationReviewed byCAN/CSA-Z11140-1-07Sterilization of health care products Chemicalindicators Part 1: General requirementsMarch 2007 Canadian Standards Association CSA/3CAN/CSA-Z11140-

36、1-07Sterilization of health care products Chemical indicators Part 1: General requirementsCSA PrefaceThis is the second edition of CAN/CSA-Z11140-1, Sterilization of health care products Chemicalindicators Part 1: General requirements, which is an adoption without modification of the identically tit

37、led ISO (International Organization for Standardization) Standard 11140-1 (second edition, 2005-07-15). It supersedes the previous edition published in 1998 as CAN/CSA-Z11140-1 (adoptedISO 11140-1:1995).This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization,

38、 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 the Standards Council of Canada.March 2007 Canadian Standards Association 2007All righ

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41、A.ca or call toll-free 1-800-463-6727 or 416-747-4044.Reference numberISO 11140-1:2005(E)ISO 2005INTERNATIONAL STANDARD ISO11140-1Second edition2005-07-15Sterilization of health care products Chemical indicators Part 1: General requirements Strilisation des produits de sant Indicateurs chimiques Par

42、tie 1: Exigences gnrales ISO 11140-1:2005(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 perfo

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45、ecretariat at the address given below. ISO 2005 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

46、 address below or ISOs member 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 2005 All rights reservedCAN/CSA-Z11140-1-07ISO 11140-1:2005(E) ISO 2005 All rights re

47、served iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Classification. 3 5 General requirements. 4 6 Performance requirements 6 7 Test methods. 7 8 Additional requirements for process (Class 1) indicators . 10 9 Additional requirements

48、for single variable (Class 3) indicators 13 10 Additional requirements for multi-variable (Class 4) indicators 13 11 Additional requirements for steam integrating (Class 5) indicators . 14 12 Additional requirements for dry heat integrating (Class 5) indicators . 14 13 Additional requirements for et

49、hylene oxide integrating (Class 5) indicators 15 14 Additional requirements for emulating (Class 6) indicators 16 Annex A (informative) Method for demonstrating shelf life of the product . 17 Annex B (informative) Examples of testing indicators. 18 Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in ISO 11138 and microbial inactivation 19 Annex D