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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
