CSA Z314 14-2015 Selection and use of packaging (sterile barrier systems) in healthcare settings (Fifth Edition).pdf

1、Z314.14-15Selection and use of packaging (sterile barrier systems) in healthcare settingsLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process

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18、nd conditions of this Legal Notice.Standards Update ServiceZ314.14-15August 2015Title: Selection and use of packaging (sterile barrier systems) in healthcare settingsTo register for e-mail notification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID tha

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21、dards and related publications, visit our Online Store at shop.csa.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association, operating as “CSA Group”Selection and use of packaging (sterile barrier systems) in healthcare settingsZ314.14-15Z314.14-15Sel

22、ection and use of packaging (sterile barrier systems) in healthcare settingsAugust 2015 2015 CSA Group 1ContentsTechnical Committee on Sterilization 3Subcommittee on Packaging 7Preface 100 Introduction 111 Scope 112 Reference publications 133 Definitions 154 General requirements for all packaging sy

23、stems 174.1 General 174.2 Evaluation, purchase, and inspection 184.3 Product design 184.4 Assembly 194.5 Labelling or labelling information 194.6 Packaging system performance testing 204.7 Sterile barrier system stability 215 Pouches and rolls 215.1 Evaluating for purchase 215.2 Using pouches 225.3

24、Selection and package assembly 235.4 Testing 235.4.1 General 235.4.2 Verification of the closure seal process 235.4.3 Installation qualification of heat sealer 235.4.4 Operational qualification (OQ) 245.4.5 Performance qualification (PQ) 246 Wrappers 256.1 Barrier properties of single- and multiple-

25、use wrapper 256.1.1 Microbiological barrier 256.1.2 Maintenance of package integrity (shelf life) 256.1.3 Liquid barrier 256.2 Evaluation for purchase 266.3 Using wrappers 276.4 Wrapper selection and package assembly 276.4.1 General 276.4.2 Wrapping techniques/methods 286.4.3 Closures/sealing 286.4.

26、4 Labelling 286.5 Verification of the wrapping process (folding and closing of sterilization wraps) 29Z314.14-15Selection and use of packaging (sterile barrier systems) in healthcare settingsAugust 2015 2015 CSA Group 26.5.1 Installation qualification (IQ) 296.5.2 Operational qualification (OQ) 296.

27、5.3 Performance qualification 307 Sterilization trays and container systems 317.1 General 317.2 Evaluation for purchase 317.2.1 General 317.2.2 Inspection of newly purchased or acquired sterilization trays and container systems 337.3 Testing 347.3.1 Pre-purchase 347.3.2 Common test procedures for al

28、l sterilization trays and container systems 357.3.3 Testing requirements specific to dynamic-air-removal (pre-vacuum) and gravity-displacement steam sterilizers 377.3.4 Testing requirements for chemical sterilizers 377.4 Using sterilization trays and container systems 377.4.1 Disassembly 377.4.2 Dec

29、ontamination 377.4.3 Inspection 387.4.4 Preparation and assembly 397.4.5 Use of absorbent materials 417.4.6 Accessories 417.4.7 Pouches and wraps 417.4.8 Security of lids 427.4.9 Chemical indicators 427.4.10 Additional requirements for sterilization container systems 427.5 Quality assurance 437.5.1

30、General 437.5.2 Maintenance of sterilization trays and container systems 43Annex A (informative) Guidance for the purchase of sterilization container systems 47Annex B (normative) Information to be supplied by the manufacturer 54Annex C (informative) Properties of sterilization wrappers 57Z314.14-15

31、Selection and use of packaging (sterile barrier systems) in healthcare settingsAugust 2015 2015 CSA Group 3Technical Committee on SterilizationI. Pequegnat STERIS Canada Inc, Mississauga, Ontario Category: Producer InterestChairG. Schultz Winnipeg Regional Health Authority, Winnipeg, Manitoba Catego

32、ry: User InterestVice-ChairN. Aelick Health Sciences North / Horizon Sant-Nord, Sudbury, Ontario AssociateR.C. Bauer 3M Canada Company 3M HealthCare, London, Ontario Category: Producer InterestB. Bolding Consultant, Burnaby, British Columbia Category: General InterestD. Bosnjak Hamilton Health Scien

33、ces, Hamilton, Ontario Category: User InterestL. Buist Interior Health Authority, Kelowna, British Columbia Category: User InterestL. Coutoulas Southlake Regional Health Centre, Newmarket, Ontario Category: User InterestR. De Medeiros Getinge Canada Limited, Mississauga, Ontario Category: Producer I

34、nterestM. Deeves Public Health Ontario-Regional, Orillia, Ontario Category: Government and/or Regulatory AuthorityS. Dufresne TSO3 Inc, Qubec, Qubec Category: Producer InterestZ314.14-15Selection and use of packaging (sterile barrier systems) in healthcare settingsAugust 2015 2015 CSA Group 4C. Hanc

35、ock Charles O. Hancock Associates, Inc., Fairport, New York, USA Category: General InterestP.M. Haney Keir Surgical Ltd., Vancouver, British Columbia Category: Producer InterestS. Jacka Alberta Health, Edmonton, Alberta Category: Government and/or Regulatory AuthorityL. Jakeman L Jakeman Consulting,

36、 West Porters Lake, Nova Scotia Category: General InterestM. Kanlic St Josephs Healthcare - Charlton Campus, Hamilton, Ontario AssociateR. Khotar Providence Health Care, Vancouver, British Columbia Category: User InterestL. Kingsbury Consultant, Vancouver, British Columbia Category: General Interest

37、C. Landers Weeneebayko Area Health Authority, Moose Factory, Ontario Category: General InterestN. Mazurat University of Manitoba College of Dentistry, Winnipeg, Manitoba AssociateP.J. McCormick Bausch b) provide an explanation of circumstances surrounding the actual field condition; andc) where poss

38、ible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.Committee interpretations are processed in accordance with the CSA Directives and guidelines governing standardization and are available on the Current Standards Activities page at standardsactivities.

39、csa.ca.5) This Standard is subject to review five years from the date of publication. Suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiriescsagroup.org and include “Proposal for change” in th

40、e subject line: a) Standard designation (number);b) relevant clause, table, and/or figure number;c) wording of the proposed change;d) rationale for change.Z314.14-15Selection and use of packaging (sterile barrier systems) in healthcare settingsAugust 2015 2015 CSA Group 11Z314.14-15Selection and use

41、 of packaging (sterile barrier systems) in healthcare settings0 IntroductionMedical devices are used in every medical procedure. Patients and healthcare professionals expect these medical devices to be safe. The safety of medical devices begins with the manufacturer and is supported by a system of n

42、ational standards and government regulations that includes medical device licensing, construction and performance standards, and problem reporting systems. These systems serve as a guide for healthcare facilities and users to ensure proper care and handling is achieved every time a medical device is

43、 used.Within this structure there are, departments, clinics, and offices located on and off site that reprocess medical devices. These areas play an essential role and face unique challenges. Unlike the medical device manufacturer, medical device reprocessing personnel work with a wide array of medi

44、cal devices manufactured by different companies, these medical devices are received in varying states of cleanliness and repair. It is the responsibility of the medical device reprocessing department (MDRD) to develop standard operating procedures that provide for each step of the cleaning, inspecti

45、on, and functionality testing, followed by disinfection or sterilization for each medical device. These standard operating procedures are developed using the device manufacturers validated written instruction for reprocessing a reusable medical device. The goal is to provide medical devices that per

46、form as intended by the manufacturer and are safe for reuse.Packaging is a vital step in reprocessing. The user requires knowledge of the quality and type of packaging required to maintain the sterility of medical devices. Packaging is available in many types and this Standard will address the types

47、, quality and wrapping techniques.This Standard is one of a series of standards to be used in conjunction with CSA Z314.0, Medical device reprocessing General requirements, which provides a framework to establish, document, and maintain requirements for the reprocessing of medical devices as part of

48、 a quality management system. This Standard is intended to provide comprehensive requirements for the safe and reliable packaging of reusable medical devices.1 Scope1.1 This Standard defines essential elements for the evaluation, selection, inspection, and proper use of preformed sterile barrier sys

49、tems, sterile barrier systems, and packaging systems. The selection criteria include minimum performance requirements to help healthcare settings choose products that are appropriate for their intended use.Z314.14-15Selection and use of packaging (sterile barrier systems) in healthcare settingsAugust 2015 2015 CSA Group 121.2 This Standard applies to the followinga) reusable sterilization container systems including trays and cassettes intended for use in sterilization processes that do not rely on wrapping;b) sterilization wraps including i) reusable