CAN CSA-C22 2 NO 80601-2-13-2015 Medical electrical equipment - Part 2-13 Particular requirements for basic safety and essential performance of an anaesthetic workstation (First Ed.pdf

1、 ISO 2011. CSA Group 2015. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-C22.2 No. 80601-2-13:15(ISO 80601-2-13:2011, MOD)National Standard of CanadaCAN/CSA-C22.2 No. 80601-2-13:15Medical electrical equipment Part 2-13: Particularrequirements for basic safety and esse

2、ntial performance ofan anaesthetic workstation(ISO 80601-2-13:2011, MOD)Legal 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 brings together vo

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37、 StandardizationApproved byMedical electrical equipment Part 2-13:Particular requirements for basic safety andessential performance of an anaestheticworkstation(ISO 80601-2-13:2011, MOD)CAN/CSA-C22.2 No. 80601-2-13:15National Standard of CanadaCAN/CSA-C22.2 No. 80601-2-13:15Medical electrical equipm

38、ent Part 2-13: Particular requirements forbasic safety and essential performance of an anaesthetic workstationNovember 2015 2015 CSA GroupCSA/5CAN/CSA-C22.2 No. 80601-2-13:15Medical electrical equipment Part 2-13:Particular requirements for basic safetyand essential performance of ananaesthetic work

39、station(ISO 80601-2-13:2011, MOD)CSA PrefaceThis is the first edition of CAN/CSA-C22.2 No. 80601-2-13, Medical electrical equipment Part 2-13:Particular requirements for basic safety and essential performance of an anaesthetic workstation, whichis an adoption, with Canadian deviations, of the identi

40、cally titled ISO (International Organization forStandardization) Standard 80601-2-13 (first edition, 2011-08-01). It replaces the previous edition,published in 2007 as CAN/CSA-C22.2 No. 60601-2-13, Medical electrical equipment Part 2-13:Particular requirements for the safety and essential performanc

41、e of anaesthetic systems (adopted IEC60601-2-13:2003+A1:2006). It is one in a series of Standards issued by CSA Group under Part II of theCanadian Electrical Code.For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 80601-2-13” throughout.This Standard is intended to be used in conju

42、nction with CAN/CSA-C22.2 No. 60601-1:14, Medicalelectrical equipment Part 1: General requirements for basic safety and essential performance (adoptedIEC 60601-1:2005+A1:2012, with Canadian deviations).This Standard is considered suitable for use for conformity assessment within the stated scope of

43、theStandard.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer andCommercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirementsfor Electrical Safety, and has been formally approved by the Technical Committee. Due to the m

44、edicalcontent of this Standard, it was also approved by the CSA Technical Committee on Perioperative Safetyunder the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for t

45、he change.CAN/CSA-C22.2 No. 80601-2-13:15Medical electrical equipment Part 2-13: Particular requirements forbasic safety and essential performance of an anaesthetic workstationNovember 2015 2015 CSA GroupCSA/7Canadian deviationsThe following deviations are intended to meet Canadian product requireme

46、nts and to align with theCanadian Electrical Code, Part I.International Standard ISO 80601-2-13:2011 (first edition) forms the basis forCAN/CSA-C22.2 No. 80601-2-13, which contains the following deviations in addition to those shown inCAN/CSA-C22.2 No. 60601-1:14.Replace all references to “IEC 60601

47、-1” with “CAN/CSA-C22.2 No. 60601-1”201.1 Scope, object and related standards201.1.1 *ScopeAdd the followingThis Standard covers medical electrical equipment that is intended to be installed or used in accordancewith CSA C22.1, Canadian Electrical Code, Part I.Add the following noteNote 1A: Attentio

48、n should be directed to the recommendations for patient monitoring duringanaesthesia made by national, professional, and regulatory bodies. These recommendations include, butare not limited to, pulse oximetry, electrocardiographic monitoring, and monitoring of blood pressure,anaesthetic agent concen

49、tration, end-tidal CO2, and body temperature.201.2 Normative referencesAdd the following to the list of ISO and IEC referencesAny reference to International Standards that are adopted as National Standards of Canada subsequentto the publication of CAN/CSA-C22.2 80601-2-13 shall be replaced by the relevant National Standard ofCanada.CSA GroupWhere reference is made to CSA Group publications, such reference shall be considered to refer to thelatest edition and all amendments published to that edition. This Standard refers to the follo