CSA Z314 10 1-2015 Selection and use of gowns and drapes intended for use in health care settings (Second Edition).pdf

1、Z314.10.1-15Selection and use of gowns and drapesintended for use in health care settingsLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approvedby the Standards Council of Canada. This process b

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18、tice.Standards Update ServiceZ314.10.1-15August 2015Title: Selection and use of gowns and drapes intended for use in health care settingsTo register for e-mail notification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register f

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20、o part of this publication may be reproduced in any form whatsoeverwithout the prior permission of the publisher.Published in August 2015 by CSA GroupA not-for-profit private sector organization178 Rexdale Boulevard,Toronto, Ontario, Canada M9W 1R3To purchase standards and related publications, visi

21、t 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 gowns anddrapes intended for use in healthcare settingsZ314.10.1-15Z314.10.1-15Selection and use of gowns and drapes

22、intended for use inhealth care settingsAugust 2015 2015 CSA Group 1ContentsTechnical Committee on Sterilization 3Subcommittee on Packaging 7Preface 100 Introduction 111 Scope 112 Reference publications 123 Definitions 144 General requirements 164.1 General 164.2 Device labelling 174.3 Package labell

23、ing 175 Evaluation and purchase of reusable gowns and drapes 175.1 General 175.2 Barrier classifications 195.2.1 Gowns 195.2.2 Surgical drapes 205.3 Flammability 205.3.1 Gowns and drapes 205.3.2 Materials intended for use in laser or cautery procedures 215.4 Biocompatibility 215.5 Requirements speci

24、fic to gowns and drapes 215.5.1 General 215.5.2 Surgical gowns 225.5.3 Isolation gowns 236 Selection of gowns and drapes 236.1 General 236.2 Selection requirements for surgical gowns 246.3 Selection requirements specific to surgical drapes 247 Use of gowns and drapes 257.1 General 257.1.1 Handling a

25、nd use 257.1.2 Barrier effectiveness 257.1.3 Pack configuration 257.1.4 Maintenance of performance characteristics 257.2 Use of surgical gowns 267.3 Use of isolation gowns 267.4 Use of surgical drapes 26Z314.10.1-15Selection and use of gowns and drapes intended for use inhealth care settingsAugust 2

26、015 2015 CSA Group 28 Containment and handling of soiled gowns and drapes at the point of use 278.1 General 278.2 Infection prevention and control 278.3 Initial handling and containment 289 Laundering of reusable gowns and drapes 28Annex A (informative) Classification of surgical gowns and isolation

27、 gowns based on the barrierproperties of critical zones 34Annex B (informative) Guidance on selection of gowns 36Z314.10.1-15Selection and use of gowns and drapes intended for use inhealth care settingsAugust 2015 2015 CSA Group 3Technical Committee on SterilizationI. Pequegnat STERIS Canada Inc,Mis

28、sissauga, OntarioCategory: Producer InterestChairG. Schultz Winnipeg Regional Health Authority,Winnipeg, ManitobaCategory: User InterestVice-ChairN. Aelick Health Sciences North / Horizon Sant-Nord,Sudbury, OntarioAssociateR.C. Bauer 3M Canada Company 3M HealthCare,London, OntarioCategory: Producer

29、InterestB. Bolding Consultant,Burnaby, British ColumbiaCategory: General InterestD. Bosnjak Hamilton Health Sciences,Hamilton, OntarioCategory: User InterestL. Buist Interior Health Authority,Kelowna, British ColumbiaCategory: User InterestL. Coutoulas Southlake Regional Health Centre,Newmarket, Ont

30、arioCategory: User InterestR. De Medeiros Getinge Canada Limited,Mississauga, OntarioCategory: Producer InterestM. Deeves Public Health Ontario-Regional,Orillia, OntarioCategory: Government and/or Regulatory AuthorityS. Dufresne TSO3 Inc,Qubec, QubecCategory: Producer InterestZ314.10.1-15Selection a

31、nd use of gowns and drapes intended for use inhealth care settingsAugust 2015 2015 CSA Group 4C. Hancock Charles O. Hancock Associates, Inc.,Fairport, New York, USACategory: General InterestP.M. Haney Keir Surgical Ltd.,Vancouver, British ColumbiaCategory: Producer InterestS. Jacka Alberta Health,Ed

32、monton, AlbertaCategory: Government and/or Regulatory AuthorityL. Jakeman L Jakeman Consulting,West Porters Lake, Nova ScotiaCategory: General InterestM. Kanlic St Josephs Healthcare - Charlton Campus,Hamilton, OntarioAssociateR. Khotar Providence Health Care,Vancouver, British ColumbiaCategory: Use

33、r InterestL. Kingsbury Consultant,Vancouver, British ColumbiaCategory: General InterestC. Landers Weeneebayko Area Health Authority,Moose Factory, OntarioCategory: General InterestN. Mazurat University of Manitoba College of Dentistry,Winnipeg, ManitobaAssociateP.J. McCormick Bausch b) provide an ex

34、planation of circumstances surrounding the 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 a

35、nd are available on the Current Standards Activities page at standardsactivities.csa.ca.5) This Standard is subject to review five years from the date of publication. Suggestions for its improvement willbe referred to the appropriate committee. To submit a proposal for change, please send the follow

36、inginformation to inquiriescsagroup.org and 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;d) rationale for change.Z314.10.1-15Selection and use of gowns and drapes intended for use

37、inhealth care settingsAugust 2015 2015 CSA Group 11Z314.10.1-15Selection and use of gowns and drapesintended for use in health care settings0 IntroductionGowns and drapes are important elements of infection prevention and control programs within healthcare settings. The safety of patients and staff

38、depends on the correct choice of products for eachpurpose, and on the maintenance of the products protective qualities through proper use and care.Misuse significantly decreases the protective qualities of gowns and drapes, thereby increasing the riskposed to patients and staff, as well as increasin

39、g costs.This Standard specifies requirements for the selection and use of reusable and single-use gowns anddrapes and provides this information for health care settings and their laundries, whether in-house oroutsourced. It is intended to ensure the safety and serviceability of surgical gowns, isola

40、tion gowns, anddrapes, and to promote safe infection prevention and control practices for the protection of patientsand health care personnel.This Standard is intended to be used with CSA Z314.14, CSA Z314.10.2 and relevant aspects ofCSA Z314.0, and other standards in the CSA Z314 series.1 Scope1.1T

41、his Standard defines essential elements in the selection and use of gowns and drapes in health caresettings and laundry services. Included in the selection criteria are minimum construction andperformance requirements for gowns and drapes, to help health care settings choose products withbarrier qua

42、lities that are appropriate for their intended use.1.2This Standard specifies requirements for the following areas:a) responsibilities of the health care settings and laundry services administration;b) policies and procedures relating to the selection and use of gowns and drapes;c) quality systems a

43、nd documentation;d) qualifications for personnel who handle new, laundered, and soiled gowns and drapes;e) basic characteristics and classification of, and selection criteria for, gowns and drapes;f) storage, transportation, and handling of clean and sterile gowns and drapes; andg) handling of soile

44、d gowns and drapes prior to disposal or laundering.1.3This Standard does not covera) the maintenance, laundering, and preparation of reusable gowns, and drapes, (See CSA Z314.10.2);andb) how to enclose a medical device using a wrapper (See CSA Z314.14).Note: A wrapper performing as a sterile barrier

45、 system is addressed by CSA Z314.14.Z314.10.1-15Selection and use of gowns and drapes intended for use inhealth care settingsAugust 2015 2015 CSA Group 121.4In this Standard,“shall” is used to express a requirement, i.e., a provision that the user is obliged tosatisfy in order to comply with the sta

46、ndard; “should” is used to express a recommendation or thatwhich is advised but not required; and “may” is used to express an option or that which is permissiblewithin the limits of the Standard.Notes accompanying clauses do not include requirements or alternative requirements; the purpose of anote

47、accompanying a clause is to separate from the text explanatory or informative material.Notes to tables and figures are considered part of the table or figure and may be written asrequirements.Annexes are designated normative (mandatory) or informative (non-mandatory) to define theirapplication.1.5Th

48、e values given in SI units are the units of record for the purposes of this Standard. The values given inparentheses are for information and comparison only.2 Reference publicationsThis Standard refers to the following publications, and where such reference is made, it shall be to theedition listed

49、below:CSA GroupZ314.0-13Medical device reprocessing General requirementsZ314.3-14Effective sterilization in health care settings by the steam processZ314.8-14Decontamination of reusable medical devicesZ314.10.2-15Laundering, maintenance, and preparation of reusable gowns, wrappers, and drapes in health caresettingsZ314.14-15Selection and use of packaging (sterile barrier systems) in healthcare settingsZ314.23-12Chemical sterilization of reusable medical devices in health care facilitiesZ317.10-09 (R2014)Handling of waste materials in health care facili