CSA Z314 3-2014 Effective sterilization in health care settings by the steam process (Sixth Edition Incorporates Erta January 2015).pdf

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18、 HistoryZ314.3-14, Effective sterilization in health care settings by the steamprocessErrata January 2015 Revision symbol (inmargin)Clause 8.5.2.1Standards Update ServiceZ314.3-14August 2014Title: Effective sterilization in health care settings by the steam processTo register for e-mail notification

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22、 sterilization in health caresettings by the steam processZ314.3-14Z314.3-14Effective sterilization in health care settings by the steam processAugust 2014 2014 CSA Group1ContentsTechnical Committee on Sterilization 4Subcommittee on Moist Heat (Steam) Sterilization 7Preface 90 Introduction 101 Scope

23、 102 Reference publications 113 Definitions 134 Utilities 164.1 Steam for medical device reprocessing (MDR steam) 164.1.1 General 164.1.2 MDR steam quality 164.2 MDR Steam Generation Equipment 184.3 Feed water for MDR steam generation equipment 194.4 Piping networks for MDR steam and feed water 205

24、Preparing medical devices and packages for steam sterilization 215.1 Medical devices 215.2 Packages 225.3 Chemical indicators 236 Packaging 236.1 General 236.2 Wrapping materials 246.3 Sterilization pouches 256.4 Rigid sterilization containers 256.5 Packaging methods 256.5.1 Wrapped packages 256.5.2

25、 Sterilization pouches 256.5.3 Rigid sterilization containers 266.5.4 Sealing 266.5.5 Marking and labelling 277 Sterilizer loading and operation 287.1 Loading 287.2 Operation 307.3 Unloading 307.4 Dust covers 328 Sterility assurance 328.1 General 32Z314.3-14Effective sterilization in health care set

26、tings by the steam processAugust 2014 2014 CSA Group28.2 Sterilization monitoring tools 338.2.1 Using sterilization monitoring tools 338.2.2 Changing sterilization monitoring tools 348.3 Installation and operational qualification 348.3.1 Manufacturer (or designate) responsibilities 348.3.2 Health ca

27、re setting responsibilities 358.3.3 Joint responsibilities 358.4 Operational qualification and requalification 358.4.1 Operational qualification 358.4.2 Operational requalification 368.4.3 Test method for operational qualification and requalification Biological indicator PCD 378.4.4 Air-detection te

28、st method for operational qualification and requalification of dynamic airremoval type sterilizers 398.5 Performance qualification 408.5.1 General 408.5.2 Performance qualification of products 418.5.3 Performance qualification of loads 428.6 Routine monitoring 438.6.1 General 438.6.2 Monitors of phy

29、sical parameters 438.6.3 Chemical indicators 448.6.4 Biological indicators 458.7 Release of processed loads 478.7.1 Release of routine loads 478.7.2 Release of loads containing implantable devices 478.8 Monitoring extended steam sterilization cycles 478.9 Documenting sterility assurance procedures a

30、nd test results 498.9.1 Load control label 498.9.2 Printouts or electronic cycle records 498.9.3 Sterilization process records 498.10 Interpretation and response to failed chemical indicator tests 508.11 Interpretation and response to a failed biological indicator test or failed air removal test 509

31、 Immediate use steam sterilization (IUSS) 529.1 General requirements 529.2 Personnel 569.3 Work areas and equipment 579.4 Decontamination 589.5 Preparation of items for IUSS 589.5.1 General 589.5.2 Packaging for IUSS 589.6 Sterilizer loading and operation 589.6.1 Loading 589.6.2 Operation 589.6.3 Un

32、loading and transfer to the sterile field 609.7 Storage 609.8 Sterility assurance 609.9 Maintenance and sterilizer quality assurance 61Z314.3-14Effective sterilization in health care settings by the steam processAugust 2014 2014 CSA Group3Annex A (informative) Examples for performance qualification

33、of products and loads 68Annex B (informative) Tools and indicators for sterilization monitoring 70Annex C (informative) Specifications and calculations for the density of muslin textile packages 73Annex D (informative) Steam quality 74Annex E (informative) In-house prepared PCDs 76Annex F (informati

34、ve) Moisture assessment 78Annex G (informative) Relevant standards 84Z314.3-14Effective sterilization in health care settings by the steam processAugust 2014 2014 CSA Group4Technical Committee on SterilizationI. Pequegnat STERIS Canada Inc.,Mississauga, OntarioCategory: Producer InterestChairG. Schu

35、ltz Winnipeg Regional Health Authority,Winnipeg, ManitobaCategory: User InterestVice-ChairN. Aelick Sudbury, OntarioCategory: User InterestR.C. Bauer 3M Canada Company 3M HealthCare,London, OntarioCategory: Producer InterestB. Bolding Burnaby, British ColumbiaCategory: General InterestL. Buist Inter

36、ior Health Authority,Kelowna, British ColumbiaCategory: User InterestM. Chaunet TSO3 Inc.,Qubec, QubecCategory: Producer InterestA. Clift Janeway Childrens Health and Rehabilitation Centre,St. Johns, Newfoundland and LabradorAssociateL. Coutoulas Southlake Regional Health Centre,Newmarket, OntarioCa

37、tegory: User InterestR. De Medeiros Getinge Canada Limited,Mississauga, OntarioCategory: Producer InterestM. Deeves Public Health Ontario-Regional,Orillia, OntarioCategory: Government and/or Regulatory AuthorityZ314.3-14Effective sterilization in health care settings by the steam processAugust 2014

38、2014 CSA Group5C. Hancock Charles O. Hancock Associates, Inc.,Fairport, New York, USACategory: General InterestP.M. Haney Keir Surgical Ltd.,Vancouver, British ColumbiaCategory: Producer InterestL. Jakeman L Jakeman Consulting,West Porters Lake, Nova ScotiaCategory: General InterestR. Khotar Provide

39、nce Health Care,Vancouver, British ColumbiaCategory: User InterestL. Kingsbury Vancouver, British ColumbiaCategory: General InterestC. Landers Weeneebayko General Hospital,Moose Factory, OntarioCategory: General InterestP.J. McCormick Bausch b) provide an explanation of circumstances surrounding the

40、 actual field condition; andc) where possible, phrase the request in such a way that a specific “yes” or “no” answer will address theissue.Committee interpretations are processed in accordance with the CSA Directives and guidelines governingstandardization and are available on the Current Standards

41、Activities page at standardsactivities.csa.ca.5) This Standard is subject to review five years after date of publication, and suggestions for its improvementwill be referred to the appropriate committee. To submit a proposal for change, please send the followinginformation to inquiriescsagroup.org a

42、nd include “Proposal for change” in the subject line:a) Standard designation (number);b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.Z314.3-14Effective sterilization in health care settings by the steam processAugust 2014 2014 CSA Gr

43、oup10Z314.3-14Effective sterilization in health caresettings by the steam process0 IntroductionMedical devices are used in nearly every medical procedure. Patients and health care professionalsexpect these medical devices to be functionally and microbiologically safe. The safety of medical devicesbe

44、gins with the manufacturer and is supported and maintained by a system of national standards andgovernment regulations that includes medical device licensing, construction and performancestandards, and problem reporting systems.Within this structure, areas or departments that reprocess medical devic

45、es within or for a health caresetting play an essential role and face unique challenges. Unlike a medical device manufacturer, medicaldevice reprocessing personnel work with a wide array of medical devices manufactured by differentcompanies, received in varying states of cleanliness and repair. It i

46、s the responsibility of the MedicalDevice Reprocessing Department (MDRD) to decontaminate, inspect, perform necessary maintenance,and disinfect or sterilize each medical device using the device manufacturer validated methodologies.The goal is to provide medical devices that perform as intended by th

47、e manufacturer and are safe forreuse.This Standard is one of a series of standards to be used in conjunction with CSA Z314.0, Medical devicereprocessing General requirements, which provides a framework to establish, document, andmaintain requirements for the reprocessing of medical devices as part o

48、f a quality management system.CSA Z314.3 is intended to provide requirements for the safe and reliable steam sterilization of reusablemedical devices, water and steam quality, and extended steam sterilization cycles.1 Scope1.1This Standard specifies essential elements for using steam to sterilize me

49、dical devices in health caresettings, with the object of achieving an adequate level of sterility assurance and minimizing the risk ofinjury to health care setting personnel and patients.Notes:1) The term “health care setting” includes, but is not limited to, hospitals, nursing homes, extended-carefacilities, clinics, medical and dental offices, and health units in industry. See CSA Z314.0 for a morecomprehensive definition.2) Comprehensive guidance for small, community health care settings can be found in CSA SPE-1112.1.2This Standard incl