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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

3、arch2007Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and

4、develop a standard. Although CSA administers the process and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranti

5、es, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringement of any third partys intellectual property rights. CSA does not warrant th

6、e accuracy, completeness, or currency of any of the information published in this document. CSA makes no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COM

7、PANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER CO

8、MMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In

9、publishing and making this document available, CSA is not undertaking to render professional or other services for or on behalf of any person or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directed to those who have the

10、appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility whatsoever arising in any way from any and all use of or reliance on the information contained in this document. CSA is a private not-for-profit company that publishes voluntary standards and related do

11、cuments. CSA has no power, nor does it undertake, to enforce compliance with the contents of the standards or other documents it publishes. Intellectual property rights and ownershipAs between CSA and the users of this document (whether it be in printed or electronic form), CSA is the owner, or the

12、authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and all inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and

13、applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate laws that protect CSAs and/or others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for such use, modification, copying

14、, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual property rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA shall not be held responsible for ident

15、ifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA for informational and non-commercial use only. Th

16、e user of this document is authorized to do only the following:If this document is in electronic form:.load this document onto a computer for the sole purpose of reviewing it;.search and browse this document; and.print this document. Limited copies of this document in print or paper form may be dist

17、ributed only to persons who are authorized by CSA to have such copies, and only if this Legal Notice appears on each such copy.In addition, users may not and may not permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without aut

18、horization from CSA; or.make an electronic copy of this document.If you do not agree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them

19、immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the Natio

20、nal Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional

21、 organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, compa

22、nies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and skills to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining membership

23、s together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSAs standards development activities. The Association offers certification and testing services in support of and as an extension to its standards development act

24、ivities. To ensure the integrity of its certification process, the Association regularly and continually audits and inspects products that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspectio

25、n and testing agencies in eight countries. Since 1919, the Association has developed the necessary expertise to meet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and service

26、s through the use of standards, certification and related services to meet national and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is thecoordi

27、nating body of the National StandardsSystem, a coalition of independent, autonomousorganizations working towards the furtherdevelopment and improvement of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary standardization as a meanso

28、f advancing the national economy, benefiting thehealth, safety, and welfare of the public, assistingand protecting the consumer, facilitating domesticand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a standardprepared o

29、r reviewed by an accredited Standards Development Organization (SDO) and approved by the SCC according to the requirements of CAN-P-2. Approval does not refer to the technical content of the standard; this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of c

30、apable individuals whose collective interests provide, to the greatest practicable extent, a balance of representation of general interests, producers, regulators, users (including consumers), and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard

31、 which is capable of making a significant and timely contribution to the national interest.Those who have a need to apply standards areencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO which publishes the stand

32、ard.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Sta

33、ndard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in March 2007 b

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

39、 the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this International Standard” 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 St

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

42、ay 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 performing the editing. In downloading this file, parties accept therein the res

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)

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