CAN CSA-Z11135-2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical .pdf

《CAN CSA-Z11135-2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical .pdf》由会员分享，可在线阅读，更多相关《CAN CSA-Z11135-2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical .pdf（100页珍藏版）》请在麦多课文档分享上搜索。

1、 ISO 2014. CSA Group 2015. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA- Z11135:15(ISO 11135:2014, MOD)National Standard of CanadaCAN/CSA- Z11135:15Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routinecontrol of

2、 a sterilization process for medical devices(ISO 11135:2014, MOD)Legal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops st andards through a consensus st andards development pro cess appr ovedby the Standards Council of Canada. This process brings together volun

3、teer s representing varied viewpoints and interes ts to achieve consensusand develop a standard. Although CSA Group administ ers the process and establishes rules to pro mote fairness in achieving consensus, it doesnot independently t est, evaluate, or verify the content of standards.Disclaimer and

4、exclusion of liabilityThis document is pro vided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation,implied warranties or conditions concerning this document s fitness for a particular purpose or use, its merchantability , or its non

5、-infringementof any third party s intellectual pro perty rights. CSA Group does not warrant the accuracy , complet eness, or currency of any of the informationpublished in this document. CSA Group makes no representations or warranties regarding this document s compliance with any applicablestatut e

6、, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, 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 SPE

7、CIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGEDDATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHERTHEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT

8、, EVEN IF CSA GROUPHAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA Group is not undertaking to render pro fessional or other services for or on behalf of anyperson or entity or to perform any duty owed by any

9、 person or entity to another person or entity . The information in this document is directedto those who have the appropriat e degree of experience to use and apply its conten ts, and CSA Group accepts no responsibility whatsoeverarising in any way from any and all use of or reliance on the informat

10、ion contained in this document.CSA Group is a private not -for -profit company that publishes voluntary standards and related documents. CSA Group has no power , nor does itundertake, to enforce compliance with the contents of the standards or other documents it publishes.Intellectual property right

11、s and ownershipAs between CSA Group and the users of this document (whether it be in print ed or electronic form), CSA Group is the owner , or the authorizedlicensee, of all works contained herein that are pro tect ed by copyright, all trade-marks (except as otherwise not ed to the contrary), and al

12、linventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are prot ected bypatents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document mayviolate laws that pro tect

13、CSA Groups and/or other s int ellectual property and may give rise to a right in CSA Group and/or others to seek legalredress for such use, modification, copying, or disclosure. To the extent permitt ed by licence or by law , CSA Group reserves all int ellectualproperty rights in this document.Paten

14、t rightsAtt ention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not beheld responsible for identifying any or all such patent rights. Users of this st andard are expressly advised that determ ination of the validity ofany

15、 such patent rights is entirely their own responsibility .Authorized use of this documentThis document is being provided by CSA Group for informational and non-commercial use only . The user of this document is authorized to doonly the following:If this document is in electronic form: load this docu

16、ment onto a computer for the sole purpose of reviewing it; search and bro wse this document; and print this document if it is in PDF format.Limited copies of this document in print or paper form may be distribut ed only to persons who are authorized by CSA Group to have suchcopies, and only if this

17、Legal Notice appear s 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 Group; or make an electronic copy of this document.If you do not a

18、gree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make anycopies of the contents hereof, and if you do make such copies, you are required to destr oy them immediately . Use of this documentconstitut es your acceptance of the terms and

19、conditions of this Legal Notice.Standards Update ServiceCAN/CSA- Z11135:15November 2015Title: Sterilization of health-care products Ethylene oxide Requirements for thedevelopment, validation and routine control of a sterilization process for medical devicesTo regist er for e-mail notification about

20、any updat es to this publication go to shop.csa.ca click on CSA Updat e ServiceThe List ID that you will need to regist er for updat es to this publication is 2424140.If you require assista nce, please e-mail t echsupportcsagr oup.org or call 416-747-2233.Visit CSA Gr oups policy on privacy at www .

21、csagr oup.org/legal to find out how we prot ect yourper sonal information.Canadian Standards Association (operating as “CSA Gro up”) , underwhose auspices this National Standard has been pro duced, waschartered in 1919 and accredited by the Standards Council ofCanada to the National Standards sys te

22、m in 1973. It is a not -for -pro fit, nonstatutory , voluntary membership association engaged inst andards development and certification activities.CSA Group standards reflect a national consensus of producer s andusers including manufacturers, consumers, retailers, unions andpro fessional organizat

23、ions, and governmental agencies. Thest andards are used widely by industry and commerce and oft enadopted by municipal, provincial, and federal governments in theirregulations, particularly in the fields of health, safety , building andconstruction, and the environment.Individuals, companies, and as

24、sociations across Canada indicat etheir support for CSA Groups standards development byvolunteering their time and skills to Committ ee work and supportingCSA Groups objectives thro ugh sustaining memberships. The morethan 7000 committ ee volunteer s and the 2000 sustainingmemberships together form

25、CSA Groups total membership fromwhich its Directors are chosen. Sustai ning memberships represent amajor source of income for CSA Groups standards developmentactivities.CSA Group offers certification and tes ting services in support of andas an extensio n to its standards development activities. To

26、ensurethe integrity of its certification pro cess, CSA Group regularly andcontinually audits and inspects products that bear theCSA Group Mark.In addition to its head office and laboratory complex in Toronto, CSAGroup has regional branch offices in major centres across Canadaand inspection and tes t

27、ing agencies in eight countries. Since 1919,CSA Group has developed the necessary expertise to meet itscorporat e mission: CSA Group is an independent serviceorganization whose mission is to pro vide an open and effectiveforum for activities facilitating the exchange of goods and servicesthrough the

28、 use of st andards, certification and related services tomeet national and intern ational needs.For further information on CSA Group services, write toCSA Group178 Rexdale BoulevardToronto, Ontario, M9W 1R3CanadaA National Standard of Canada is a standard developed by an SCC-accredited Standards Dev

29、elopment Organization (SDO), andapproved by the Standards Council of Canada (SCC), in accordancewith SCCs: Requirements and Guidance Accreditation forStandards Development Organizations , and Requirements andGuidance Approval of National Standards of Canada Designation .More information on National

30、Standard requirements can be foundat www .scc.ca.An SCC-approve d standard reflects the consensus of a number ofexperts whose collective interes ts pro vide, to the greates tpracticable extent, a balance of representation of affectedstakeholder s. National Standards of Canada are intended to make as

31、ignificant and timely contribution to the Canadian interes t.SCC is a Crown corporation within the portfolio of Indust ry Canada.With the goal of enhancing Canadas economic competitiveness andsocial well-being, SCC leads and facilitat es the development and useof national and international standards

32、. SCC also coordinatesCanadian participation in st andards development, and identifiesstrat egies to advance Canadian st andardization efforts.Accreditation services are provided by SCC to various customer s,including product certifiers, t esting laboratories, and standardsdevelopment organizations.

33、 A list of SCC programs and accreditedbodies is publicly available at www .scc.ca.Users should always obtain the lates t edition of a National Standardof Canada from the standards development organization responsiblefor its publication, as these documents are subject to periodicreview .Standards Cou

34、ncil of Canada600-55 Metca lfe StreetOttawa, Ontario, K1P 6L5CanadaCet te Norme Nationale du Canada est disponible en versions franaise et anglaise.Although the intended primary application of this Standard is stat ed in its Scope, it is important t o note that it remains the responsibility ofthe us

35、ers to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”ICS 11.080.01ISBN 978-1-4883-0212-1 2015 CSA GroupAll rights reserved. No part of this publication may be reproduced in any form whatsoeverwithout the prior permiss

36、ion of the publisher .Published in November 2015 by CSA GroupA not -for-prof it privat e sect or organization178 Re xdale Boulevard, Toront o, Ontario, Canada M9W 1R3To purchase st andards and related publications, visit our Online Store at shop.csa.caor call to ll-free 1-800-463-6727 or 416-747-404

37、4.TMA trade-mar k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved bySterilization of health-care products Ethylene oxide Requirements for thedevelopment, validation and routine controlof a sterilization proce

38、ss for medical devices(ISO 11135:2014, MOD)CAN/CSA- Z11135:15National Standard of CanadaCAN/CSA- Z11135:15Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine controlof a sterilization process for medical devicesNovember 2015 2015 CSA GroupCSA

39、/5CAN/CSA- Z11135:15Sterilization of health-care products Ethylene oxide Requirements for thedevelopment, validation and routinecontrol of a sterilization process formedical devices(ISO 11135:2014, MOD)CSA PrefaceThis is the firs t edition of CAN/CSA-Z11135, St erilization of health-care products Et

40、hylen e o xide Requirements for the development, validation and routine control of a s te rilization process for medicaldevices , which is an adoption, with Canadian deviations, of the identically titled ISO (Inter nationalOrganization for Standardization) Standard 11135 (second edition, 2014-07-15)

41、.This Standard replaces CAN/CSA-Z11135-1-09, St erilization of health care products Ethyl ene o xide Part 1: Requirements for development, validation and routine control of a s te rilization process formedical devices (adopt ed ISO 11135-1:2007), and CAN/CSA-Z11135-2-09, St erilization of health car

42、eproducts Eth ylene oxide Part 2: Guidance on the application of ISO 11135-1 (adopt edISO/TS 11135-2:2008), which have been revised and condensed into one Standard.For brevity , this Standard will be referred to as “CAN/CSA-Z11135” throu ghout.This Standard was reviewed for Canadian adoption by the

43、CSA Technical Committ ee on Ster ilization,under the jurisdiction of the CSA Strategic Steer ing Committ ee on Health Care Technology b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.CAN/CSA- Z11135:15Sterilization of health-care produ

44、cts Ethylene oxide Requirements for the development, validation and routine controlof a sterilization process for medical devicesNovember 2015 2015 CSA GroupCSA/7Canadian deviationsThe following deviations are intende d to align with local healthcare practices and to meet therequirements of Canadian

45、 healthcare regulator s.1 Scope1.1 InclusionsAdd the followingISO 11135 specifies requirements and guidance for the development, validation, and routi ne control ofan ethylene oxide (EO) st erilization proces s for medical devices. It applies to ethylene oxide s ter ilizationin the conte xt of medic

46、al device manufacturing and medical device reproc essing departments.Prevention of exposure to EO and its by -pr oducts during use is important for patient and occupationalsafety .CSA Z314.23 and ISO 11135 are complementary Standards to be used together for s teril ization using EO.2 Normative refer

47、encesAdd the followingAny reference to Int ernational Standards that are adopted as National Standards of Canada subsequentto the publication of CAN/CSA-Z11135 shall be replaced by the relevant National Standard of Canada.Where reference is made to CSA Gr oup publications, such reference shall be co

48、nsidered to refer to thelates t edition and all amendments published to that edition. This Standard refer s to the followingpublications, and the years shown indicate the lates t editions available at the time of printing:CSA GroupZ314.23-12Chemical st erilization of reusable medical devices in heal

49、th care facilitiesEnviron ment CanadaGuidelines for the Reduction of Eth ylene Oxide Releases from St erilization Applicationshttp:/www .ec.gc.ca/CEPARegis try/guidelines/ethylene_o xide.cfmAdd the following clause3A General requirementsInsta llation instructio ns shall alert the purchaser to Envir onment Canada regulations regarding ethyleneoxide releases. See Envir onment Canadas Guidelines for the Reduction of Eth ylene Oxide Releases fromSt erilization Applications .CAN/CSA- Z11135:15Sterilization of health-care produ