CAN CSA-Z11138-1-2007 Sterilization of health care products - Biological indicators - Part 1 General requirements (First Edition).pdf

1、 Reference numberISO 11138-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11138-1Second edition2006-07-01Sterilization of health care products Biological indicators Part 1: General requirements Strilisation des produits de sant Indicateurs biologiques Partie 1: Exigences gnrales National Standard of Can

2、adaCAN/CSA-Z11138-1-07(ISO 11138-1:2006)International Standard ISO 11138-1:2006 (second edition, 2006-07-01) has been adopted withoutmodification (IDT) as CSA Standard CAN/CSA-Z11138-1-07, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-55436-446-9 M

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34、y 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 Store at www.ShopCSA.caCAN/CSA-Z11138-1-07Sterilization of health care products Biological indicators Part 1: Gene

35、ralrequirementsPrepared byInternational Organization for StandardizationRegistered trade-mark of Canadian Standards AssociationReviewed byCAN/CSA-Z11138-1-07Sterilization of health care products Biologicalindicators Part 1: General requirementsMarch 2007 Canadian Standards Association CSA/3CAN/CSA-Z

36、11138-1-07Sterilization of health care products Biological indicators Part 1: General requirementsCSA PrefaceThis is the first edition of CAN/CSA-Z11138-1, Sterilization of health care products Biological indicators Part 1: General requirements, which is an adoption without modification of the ident

37、ically titled ISO (International Organization for Standardization) Standard 11138-1 (second edition, 2006-07-01). 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, an

38、d 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 rights reserved. No part of this publication may be reproduced in any form whatsoever without

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40、andards 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 Store at www.ShopCSA.ca or call toll-free 1-800-463-6727 or 416-747-4044.Blank pageReference numberISO 11138

41、-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11138-1Second edition2006-07-01Sterilization of health care products Biological indicators Part 1: General requirements Strilisation des produits de sant Indicateurs biologiques Partie 1: Exigences gnrales ISO 11138-1:2006(E) PDF disclaimer This PDF file m

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43、ponsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creat

44、ion parameters were optimized for printing. Every care has been taken to 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. ISO 2006 All rights reserved. Unless

45、 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 member body in the country of the requester. ISO cop

46、yright 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 11138-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 1.1 General. 1 1.2 Exclusions .

47、 1 2 Normative references . 1 3 Terms and definitions. 2 4 General manufacturing requirements. 4 4.1 Manufacturing controls 4 4.2 Test organism . 5 4.3 Information supplied by manufacturer (labelling). 6 4.4 Storage and transport 6 5 Specific manufacturing requirements 7 5.1 Suspensions 7 5.2 Carrie

48、r, primary and secondary packaging . 7 5.3 Inoculated carrier 8 5.4 Biological indicators. 8 5.5 Self-contained biological indicators. 8 6 Determination of resistance 8 6.1 General resistance requirements 8 6.2 Test organism . 9 6.3 Population of test organisms 9 6.4 Resistance characteristics 9 6.5

49、 Test conditions . 10 7 Culture conditions 10 7.1 Incubator 10 7.2 Growth medium. 10 7.3 Incubation 10 Annex A (normative) Determination of viable count 11 Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes 13 Annex C (normative) D value determination by survivor curve method 15 Annex D (normative) D value determination by fraction negative method 19 Annex E (normative)