1、Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of resultsCAN/CSA-Z15882-09(ISO 15882:2008, IDT)National Standard of CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Legal Notice for StandardsCanadian Standards Association (CSA) standar
2、ds 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 develop a standard. Although CSA administers the process and establishes rules
3、 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, warranties, or conditions of any kind, express or implied, including, without limitati
4、on, 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 the accuracy, completeness, or currency of any of the information published in t
5、his 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 COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT,
6、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 COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGEN
7、CE), 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 publishing and making this document available, CSA is not undertaking to rende
8、r 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 appropriate degree of experience to use and apply its contents, and CSA accept
9、s 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 documents. CSA has no power, nor does it undertake, to enforce compliance with t
10、he 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 authorized licensee, of all works contained herein that are protected by copyr
11、ight, 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 applications for patents. Without limitation, the unauthorized use, modificati
12、on, 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, or disclosure. To the extent permitted by licence or by law, CSA reserves al
13、l 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 identifying any or all such patent rights. Users of this standard are expressly adv
14、ised 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. The user of this document is authorized to do only the following:If this documen
15、t 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 if it is in PDF format. Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA to ha
16、ve 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 authorization from CSA; or.make an electronic copy of this
17、 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 immediately. Use of this document constitutes your acce
18、ptance of the terms and conditions of this Legal Notice.CSA Standards Update ServiceCAN/CSA-Z15882-09November 2009Title:Sterilization of health care products Chemical indi cators Guidancefor selection, use and interpretation of resultsPagination:40 pages (CSA/1CSA/4, iv, and 31 text)To register for
19、e-mail notification about any updates to this publicationgo to www.ShopCSA.caclick on E-mail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publication is 2419711.If you require assistance, please e-mail techsupportcsa.ca
20、or call 416-747-2233.Visit CSAs policy on privacy at www.csagroup.org/legal to find out how we protect your personal information.TheCanadianStandardsAssociation(CSA),under whose auspices this National Standard hasbeen produced, was chartered in 1919 andaccredited by the Standards Council of Canadato
21、 the National Standards system in 1973. It is anot-for-profit, nonstatutory, voluntary membershipassociation engaged in standards development andcertification activities.CSA standards reflect a national consensus ofproducers and users including manufacturers,consumers, retailers, unions and professi
22、onalorganizations, and governmental agencies. Thestandards are used widely by industry and commerceand often adopted by municipal, provincial, andfederal governments in their regulations, particularlyin the fields of health, safety, building andconstruction, and the environment.Individuals, companie
23、s, and associations acrossCanada indicate their support for CSAs standardsdevelopment by volunteering their time and skillsto CSA Committee work and supporting theAssociations objectives through sustainingmemberships. The more than 7000 committeevolunteers and the 2000 sustaining membershipstogether
24、 form CSAs total membership from whichits Directors are chosen. Sustaining membershipsrepresent a major source of income for CSAsstandards development activities.The Association offers certification and testingservices in support of and as an extension to itsstandards development activities. To ensu
25、re theintegrity of its certification process, the Associationregularly and continually audits and inspects productsthat bear the CSA Mark.In addition to its head office and laboratorycomplex in Toronto, CSA has regional branch officesin major centres across Canada and inspection andtesting agencies
26、in eight countries. Since 1919, theAssociation has developed the necessary expertise tomeet its corporate mission: CSA is an independentservice organization whose mission is to provide anopen and effective forum for activities facilitating theexchange of goods and services through the use ofstandard
27、s, certification and related services to meetnational and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaTheStandardsCouncilofCanada(SCC) is thecoordinating body of the National Standar
28、dsSystem, 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 meansof advancing the national economy, b
29、enefiting 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 or reviewed by an accredited Standar
30、dsDevelopment Organization (SDO) and approvedby the SCC according to the requirements of CAN-P-2.Approval does not refer to the technical content of thestandard; this remains the continuing responsibility ofthe SDO. An NSC reflects a consensus of a number ofcapable individuals whose collective inter
31、ests provide,to the greatest practicable extent, a balance ofrepresentation of general interests, producers,regulators, users (including consumers), and otherswith relevant interests, as may be appropriate to thesubject in hand. It normally is a standard which iscapable of making a significant and t
32、imely contributionto 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 whichpublishes the standard.The responsibility for approving standards as
33、National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaAlthoughtheintendedprimaryapplicationofthisStandardisstatedinitsScope,itisimportanttonotethatitremainstheresponsibilityoftheuserstojudgeitssuitabilityfortheirparticularpurp
34、ose.Registeredtrade-markofCanadianStandardsAssociationCettenormeestofferteenanglaisseulementpourlemoment.LaCSApublieralaversionenfranaisdsquelleseraproduiteparlorganismerdacteur.Reviewed byNational Standard of CanadaPublished in November 2009 by Canadian Standards AssociationA not-for-profit private
35、 sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, 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-Z15882-09Sterilization of health care produc
36、ts Chemical indicators Guidancefor selection, use and interpretation of resultsCAN/CSA-Z15882-09Sterilization of health care products Chemical indicators Guidancefor selection, use and interpretation of resultsCSA/4 Canadian Standards Association November 2009CAN/CSA-Z15882-09Sterilization of health
37、 care products Chemical indicators Guidancefor selection, use and interpretation of resultsCSA PrefaceThis is the second edition of CAN/CSA-Z15882, Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results, which is an adoption without modifi
38、cation of the identically titled ISO (International Organization for Standardization) Standard 15882 (second edition, 2008-09-01). This standard supersedes the previous edition published in 2004 as CAN/CSA-Z15882 (adopted ISO 15882:2003).At the time of publication, ISO 15882:2008 is available from I
39、SO in English only. CSA will publish the French version when it becomes available from ISO.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 app
40、roved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.November 2009 Canadian Standards Association 2009All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permissio
41、n 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 Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association50
42、60 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.CSA Standards are subject to periodic review, and sugges
43、tions 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 inquiriescsa.ca and include “Proposal for change” in the subject line:(a) Standard designation (number);(b) relevant clause, table, an
44、d/or figure number;(c) wording of the proposed change; and(d) rationale for the change.Reference numberISO 15882:2008(E)ISO 2008INTERNATIONAL STANDARD ISO15882Second edition2008-09-01Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results S
45、trilisation des produits de sant Indicateurs chimiques Directives pour la slection, lutilisation et linterprtation des rsultats ISO 15882:2008(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
46、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 responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe
47、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-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO mem
48、ber bodies. 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 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or
49、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 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 2008 All rights reservedCAN/CSA-Z15882-09ISO 15882:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Term
