CAN CSA-C22 2 NO 80601-2-12-2012 Medical electrical equipment - Part 2-12 Particular requirements for basic safety and essential performance of critical care ventilators (First Edi.pdf

1、Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilatorsCAN/CSA-C22.2 No. 80601-2-12:12(ISO 80601-2-12:2011, MOD)National Standard of CanadaNOT FOR RESALE. / PUBLICATION NON DESTINE LA REVENTE.Legal Notice for StandardsCa

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20、tion, operating as “CSA Group”TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”National Standard of CanadaPublished in November 2012 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 4

21、16-747-4044Visit our Online Store at shop.csa.caPrepared byInternational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-C22.2 No. 80601-2-12:12Medical electrical equipment Part2-12: Particular requirements for basic safety and essential performance of critical care ven

22、tilatorsReviewed byCAN/CSA-C22.2 No. 80601-2-12:12Medical electrical equipment Part2-12: Particular requirementsfor basic safety and essential performance of critical care ventilatorsCSA/4 2012 CSA Group November 2012CAN/CSA-C22.2 No. 80601-2-12:12Medical electrical equipment Part2-12: Particular re

23、quirements for basic safety and essential performance of critical care ventilatorsCSA PrefaceThis is the first edition of CAN/CSA-C22.2 No. 80601-2-12, Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators, which is an

24、 adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-12 (first edition, 2011-04-15), including Technical Corrigendum 1:2011. It replaces CAN/CSA-C22.2 No. 60601-2-12, published in 2003 under the title Medical electrical

25、equipment Part 2-12: Particular requ irements for the safety of lung ventilators Critical care ventilators (adopted IEC 60601-2-12:2001). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. This Standard is intended to be used in conjunction with CAN

26、/CSA-C22.2 No. 60601-1:08, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, with Canadian deviations).This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.This Sta

27、ndard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of

28、this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology. This Standard has been approved as a National Standard of Canada by the Standards Council of Canad

29、a.Interpretations: The Strategic Steering Committee on Requirements for Electrical Safety has provided the following direction for the interpretation of standards under its jurisdiction: “The literal text shall be used in judging compliance of products with the safety requirements of this Standard.

30、When the literal text cannot be applied to the product, such as for new materials or construction, and when a relevant committee interpretation has not already been published, CSA Groups procedures for interpretation shall be followed to determine the intended safety principle.” 2012 CSA GroupAll ri

31、ghts reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of thepublisher. 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 Cana

32、da”.CAN/CSA-C22.2 No. 80601-2-12:12Medical electrical equipment Part2-12: Particular requirementsfor basic safety and essential performance of critical care ventilatorsNovember 2012 2012 CSA Group CSA/5Inquiries regarding this National Standard of Canada should be addressed toCSA Group5060 Spectrum

33、Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000http:/csa.caTo purchase standards and related publications, visit our Online Store at shop.csa.ca or call toll-free 1-800-463-6727 or 416-747-4044.This Standard is subject to periodic review, and suggestions for its impro

34、vement 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 the subject line:(a) Standard designation (number);(b) relevant clause, table, and/or figure number;(c) wording o

35、f the proposed change; and(d) rationale for the change.CAN/CSA-C22.2 No. 80601-2-12:12Medical electrical equipment Part2-12: Particular requirementsfor basic safety and essential performance of critical care ventilatorsCSA/6 2012 CSA Group November 2012Canadian deviationsReplace all references to “I

36、EC 60601-1” with “CAN/CSA-C22.2 No. 60601-1”201.2 Normative referencesAdd the followingThe following CSA Group Standards are adoptions of, or equivalent to, the International Standards listed in square brackets below each entry. The requirements of these CSA Group Standards shall take precedence ove

37、r the International Standards listed below; any reference in CAN/CSA-C22.2 No. 80601-2-12 to the International Standard shall be replaced by a reference to the equivalent Canadian Standard. Any reference to International Standards that are adopted as National Standards of Canada subsequent to the pu

38、blication of CAN/CSA-C22.2 No. 80601-2-12 shall be replaced by the relevant National Standard of Canada.CSA GroupCAN/CSA-C22.2 No. 60529:05 (R2010)Degrees of protection provided by enclosures (IP Code)Replaces IEC 60529:1989+A1:1999CAN/CSA-C22.2 No. 60601-1-2:08Medical electrical equipment Part 1-2:

39、 General requ irements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and testsReplaces IEC 60601-1-2:2007CAN/CSA-C22.2 No. 60601-1-6:11Medical electrical equipment Part 1-6: General requ irements for basic safety and essential performance

40、Collateral standard: UsabilityReplaces IEC 60601-1-6:2010CAN/CSA-C22.2 No. 60601-1-8:08Medical electrical equipment Part 1-8: General requ irements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipme

41、nt and medical electrical systemsReplaces IEC 60601-1-8:2006CAN/CSA-C22.2 No. 60601-1-11:11Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in

42、 the home healthcare environmentReplaces IEC 60601-1-11:2010CAN/CSA-C22.2 No. 60601-2-2:09Medical electrical equipment Part 2-2: Particular requ irements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessoriesReplaces IEC 60601-2-2:

43、2009CAN/CSA-C22.2 No. 80601-2-12:12Medical electrical equipment Part2-12: Particular requirementsfor basic safety and essential performance of critical care ventilatorsNovember 2012 2012 CSA Group CSA/7CAN/CSA-Z5356-1:08Anaesthetic and respiratory equipment Coni cal connectors Part 1: Cones and sock

44、etsReplaces ISO 5356-1:2004CAN/CSA-Z5359:10Low-pressure hose assemblies for use with medical gasesReplaces ISO 5359:2008Z7396.1-09Medical gas pipeline systems Part 1: Pipelines for medical gases and vacuumReplaces ISO 7396-1:2007CAN/CSA-Z8185:08Respiratory tract humidifiers for medical use Particula

45、r requirements for respiratory humidification systemsReplaces ISO 8185:2007CAN/CSA-Z8836:11Suction catheters for use in the respiratory tractReplaces ISO 8836:2007CAN/CSA-Z9360-1:07 (R2012)Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for hu midifying respired gases in hu

46、mans Part 1: HMEs for use with minimum tidal volumes of 250 mlReplaces ISO 9360-1:2000CAN/CSA-Z9360-2:07 (R2012)Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for hu midifying respired gases in humans Part 2: HMEs for use with tracheostomi zed patients having minimum tidal

47、 volumes of 250 mlReplaces ISO 9360-2:2001CAN/CSA-Z10079-1:03 (R2008)Medical suction equipment Part 1: Electrically powered suction equipment Safety requirementsReplaces ISO 10079-1:1999CAN/CSA-Z10079-3:03 (R2008)Medical suction equipment Part 3: Suction equipment powered from a vacuum or pressure s

48、ourceReplaces ISO 10079-3:1999CAN/CSA-Z17664:06 (R2011)Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesReplaces ISO 17664:2004CAN/CSA-C22.2 No. 80601-2-12:12Medical electrical equipment Part2-12: Particular requirementsfor basic safety and essential performance of critical care ventilatorsCSA/8 2012 CSA Group November 2012CAN/CSA-Z23328-1:04 (R2009)Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performanceReplaces ISO 23328-1:2003CAN/CSA-Z2