CAN CSA-Z314 9-2009 Installation ventilation and safe use of ethylene oxide sterilizers in health care facilities (Third Edition Update No 1 May 2010).pdf

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34、-09Installation, ventilation, and safe use of ethylene oxide sterilizers in health care facilitiesISBN 978-1-55436-736-8Technical Editor: Jeffrey Kraegel Canadian Standards Association 2009All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior per

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39、, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caZ314.9-09Installation, ventilation, and safe use of ethylene oxide sterilizers in health care facilitiesCSA Standard100%ISBN 978-1-55436-736-8Technical Editor: Jeffrey Kraegel Canadian Standards Association 2009All ri

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41、ciation (CSA) prints its publications on Rolland Enviro100, which contains 100% recycled post-consumer fibre, is EcoLogo and Processed Chlorine Free certified, and was manufactured using biogas energy.March 2009 iiiContents Canadian Standards AssociationInstallation, ventilation, and safe use ofethy

42、lene oxide sterilizers in health care facilitiesTechnical Committee on Sterilization vSubcommittee on Ethylene Oxide Sterilization viiiPreface x1Scope 12 Reference publications 13 Definitions 24 General requirements 45Installation 45.1 Sterilization equipment location 45.2 Sterilization equipment 55

43、.3 Sterilization equipment piping 55.4 Exhaust and drain systems 65.4.1 General 65.4.2 Sterilization exhaust 65.4.3 Aeration exhaust 65.4.4 Sanitary floor drain for a Type A sterilizer 65.5 Electrical systems 65.6 Significant modifications to existing ethylene oxide sterilization areas or to existin

44、g sterilization equipment 75.7 Commissioning of new, repaired, or modified systems 76Ventilation 76.1 General 76.2 Sterilization area 86.2.1 Design parameters 86.2.2 Exhaust 86.3 Ductwork 86.4 Ventilation system evaluation 86.5 Local exhaust ventilation (LEV) 96.5.1 General 96.5.2 Design parameters

45、96.5.3 Electrical installation 106.5.4 Location of exhaust hood 106.6 Venting of sterilization equipment 106.7 Ventilation of designated storage area 106.8 Contingency plans for the ventilation system 117 Sterilization equipment preventive maintenance 118Alarms 128.1 General 128.2 LEV alarm system 1

46、28.3 Ethylene oxide alarm system 128.3.1 General 12Z314.9-09 Canadian Standards Associationiv March 20098.3.2 Sensor location 128.3.3 Response procedure 138.4 Fire alarm system 139Training 139.1 Orientation and training 139.2 Proficiency training 1410 Work practices 1411 Workplace assessment 1512 Si

47、gns 1513 Record keeping 1613.1 Documentation 1613.2 Literature file 1714 Emergency response 1714.1 General 1714.2 Emergency response team 1714.3 Emergency response plan (ERP) 1714.4 Report forms 1815 Storage of ethylene oxide 1815.1 Containers for Type A sterilizers 1815.1.1 General 1815.1.2 Sterili

48、zation area 1915.1.3 Designated storage area 1915.2 Cartridges for Type B sterilizers 1915.2.1 General 1915.2.2 Sterilization area 1915.2.3 Designated storage area 1916 Workplace monitoring 20AnnexesA (informative) Particular characteristics of and requirements for Type A and Type B ethylene oxide s

49、terilizers 24B (informative) Decision process for determining a significant modification 26C (informative) Related information and standards 33Tables1 Actions to be taken in the event of LEV failure 11Figures1 Dedicated room for Type A pass-through sterilizer Sample floor plan 212 Dedicated room for Type A single-side sterilizer Sample floor plan 223 Pressure-venting device