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
2、brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate, or verify the content of standar
3、ds.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantabi
4、lity, or its non-infringement of any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA Group makes no representations or warranties regarding this documents compliance with any appli
5、cable statute, 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
6、 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 NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE
7、 OF THIS DOCUMENT, EVEN IF CSA GROUP HAS 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 professional or other services for or on behalf of any person or entity or to perform an
8、y 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 Group accepts no responsibility whatsoever arising in any way from any and all use of or relianc
9、e on the information 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 it undertake, to enforce compliance with the contents of the standards or other documents it publishes.Intellectual
10、 property rights and ownershipAs between CSA Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contra
11、ry), 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, modification, copying, or disclosure of this document may violate laws t
12、hat protect CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights in this docum
13、ent.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validit
14、y of any 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 do only the following:If this document is in electronic form: load th
15、is 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 Group to have such copies, and only if
16、 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 Group; or make an electronic copy of this document.If you do n
17、ot 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 acceptance of the terms a
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
19、t you will need to register for updates to this publication is 2423888.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at www.csagroup.org/legal to find out how we protect your personal information.ISBN 978-1-4883-0029-5 2015 C
20、SA Group All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher.Published in August 2015 by CSA Group A not-for-profit private sector organization 178 Rexdale Boulevard, Toronto, Ontario, Canada M9W 1R3 To purchase stan
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
