CAN CSA-Z8185-2008 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (First Edition).pdf

1、 Reference numberISO 8185:2007(E)ISO 2007INTERNATIONAL STANDARD ISO8185Third edition2007-07-01Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems Humidificateurs respiratoires mdicaux Exigences spcifiques des systmes dhumidification respiratoi

2、res National Standard of CanadaCAN/CSA-Z8185-08International Standard ISO 8185:2007 (third edition, 2007-07-01) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z8185-08, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55436

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20、Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systemsPagination: 60 pages (CSA/1CSA/4, ivii, and 49 text)To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you wi

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36、se.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in August 2008 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463

37、-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z8185-08Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systemsPrepared byInternational Organization for StandardizationRegistered trade-mark of Canadian Standards AssociationReview

38、ed byCAN/CSA-Z8185-08Respiratory tract humidifiers for medical use Particularrequirements for respiratory humidification systemsAugust 2008 Canadian Standards Association CSA/3CAN/CSA-Z8185-08Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems

39、CSA PrefaceThis is the first edition of CAN/CSA-Z8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard

40、 8185 (third edition, 2007-07-01). This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Anaesthetic Equipment, under the jurisdiction of the CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Committ

41、ee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.August 2008 Canadian Standards Association 2008All rights reserved. No part of this publication may be reproduc

42、ed in any form whatsoever without the prior permission ofthe publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada s

43、hould be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.csa.caTo purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free1-800-463-6727 or 416-747-4044.CAN/

44、CSA-Z8185-08Respiratory tract humidifiers for medical use Particularrequirements for respiratory humidification systemsCSA/4 Canadian Standards Association August 2008Canadian deviations2 Normative referencesAdd the followingCSA (Canadian Standards Association)The following National Standards of Can

45、ada, published by the Canadian Standards Association, are adoptions of IEC and ISO Standards. The requirements of these CSA Standards shall take precedence over the International Standards on which they are based; any reference in CAN/CSA-Z8185 to the International Standard shall be replaced by a re

46、ference to the equivalent Canadian Standard.CAN/CSA-C22.2 No. 60601-1:08Medical electrical equipment Part 1: General requirements for basic safety and essential performanceCAN/CSA-C22.2 No. 60601-1-2:03 (R2008)Medical electrical equipment Part 1-2: General requirements for safety Collateral standard

47、: Electromagnetic compatibility Requirements and testsCAN/CSA-C22.2 No. 60601-1-6:05Medical electrical equipment Part 1-6: General requirements for safety Collateral standard: UsabilityCAN/CSA-C22.2 No. 60601-1-8:05Medical electrical equipment Part 1-8: General requirements for safety Collateral sta

48、ndard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsCAN/CSA-C22.2 No. 60601-2-12:03 (R2007)Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical care ventilatorsCAN/CSA-I

49、SO 14971:07Medical devices Application of risk management to medical devicesCAN/CSA-Z5356-1-08Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and socketsCAN/CSA-Z7396.1-06Medical gas pipeline systems Part 1: Pipelines for medical gases and vacuumCAN/CSA-Z9360-1-07Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 mLCAN/CSA-Z9360-2-07Anaesthetic and respiratory equipment