CAN CSA-C22 2 NO 80601-2-55-2014 Medical electrical equipment - Part 2-55 Particular requirements for the basic safety and essential performance of respiratory gas monitors (First .pdf

1、CAN/CSA-C22.2 No. 80601-2-55:14Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors(ISO 80601-2-55:2011, MOD)CAN/CSA-C22.2 No. 80601-2-55:14(ISO 80601-2-55:2011, MOD)National Standard of Canada ISO 2011. CSA Group

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18、dard of Canada (NSC) is a standard prepared or reviewed by an SCC-accredited SDO and approved by the SCC according to NSC approval requirements. Approval does not refer to the technical content of the standard, as this remains the responsibility of the SDO. An NSC reflects a consensus of a number of

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20、e a significant and timely contribution to the Canadian interest. Those who have a need to apply standards are encouraged to use NSCs. These standards are subject to periodic review. Users of NSCs are cautioned to obtain the latest edition from the SDO that publishes the standard. The responsibility

21、 for approving standards as NSCs rests withStandards Council of Canada 270 Albert Street, Suite 200 Ottawa, Ontario, K1P 6N7CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its sui

22、tability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”Cette Norme Nationale du Canada est disponible en versions franaise et anglaise.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”National Standard of Canad

23、aPublished in March 2014 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at shop.csa.caICS 11.040.10Prepared byInternational Organization for StandardizationCAN/CSA-C22.2 No. 8

24、0601-2-55:14Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors(ISO 80601-2-55:2011, MOD)Reviewed byApproved byCAN/CSA-C22.2 No. 80601-2-55:14Medical electrical equipment Part 2-55: Particular requirements forthe

25、basic safety and essential performance of respiratory gas monitorsCSA/4 2014 CSA Group March 2014CAN/CSA-C22.2 No. 80601-2-55:14Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors(ISO 80601-2-55:2011, MOD)CSA Pref

26、aceThis is the first edition of CAN/CSA-C22.2 No. 80601-2-55, Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organ

27、ization for Standardization) Standard 80601-2-55 (first edition, 2011-12-15). It replaces the previous edition, published in 2007 as CAN/CSA-Z21647, Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors (adopted ISO 21647:2004

28、). For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 80601-2-55” throughout.This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (adopted IEC 6060

29、1-1:2005, with Canadian deviations).This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA St

30、rategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Perioperative Safety under the jurisdiction of the CSA Strategic Steering C

31、ommittee on Health Care Technology (b) relevant clause, table, and/or figure number;(c) wording of the proposed change; and(d) rationale for the change.CAN/CSA-C22.2 No. 80601-2-55:14Medical electrical equipment Part 2-55: Particular requirements forthe basic safety and essential performance of resp

32、iratory gas monitorsCSA/6 2014 CSA Group March 2014Canadian deviationsReplace all references to “IEC 60601-1” with “CAN/CSA-C22.2 No. 60601-1”201.1 Scope, object and related standards201.1.1 ScopeAdd the followingThis Standard covers ME EQUIPMENT that is intended to be installed or used in accordanc

33、e with CSA C22.1, Canadian Electrical Code, Part I.201.2 Normative referencesAdd the following to the list of IEC documentsAny reference to International Standards that are adopted as National Standards of Canada subsequent to the publication of CAN/CSA-C22.2 No. 80601-2-55 shall be replaced by the

34、relevant National Standard of Canada.Add the followingWhere reference is made to CSA Group publications, such reference shall be considered to refer to the latest edition and all amendments published to that edition. This Standard refers to the following publications, and the years shown indicate th

35、e latest editions available at the time of printing:CSA GroupC22.1-12 Canadian Electrical Code, Part ICAN/CSA-C22.2 No. 0-10 General requirements Canadian Electrical Code, Part II201.4 General requirementsReplace this clause with the followingThis clause of Part 1 is applicable except as follows.201

36、.4.1AAdd the following clauseGeneral requirements applicable to these products are provided in CAN/CSA-C22.2 No. 0.CSA Technical Committee on Consumer and Commercial Products A. Milne 21st Olympiad Sales, Chair Burlington, Ontario Representing General Interest D. Mascarenhas Brampton, Ontario Vice-C

37、hair Representing General Interest L. Letea CSA Group, Project Manager Mississauga, Ontario Representing Government and/or Regulatory Authority D.P. Badry Government of Yukon, Whitehorse, Yukon F. La Riccia Health Canada, Risk Assessment Bureau, Ottawa, Ontario T. Olechna Electrical Safety Authority

38、, Mississauga, Ontario M. Staples City of Victoria, Victoria, British Columbia Representing Producer Interest J.E. Evans Evans Regulatory Certification Consulting, Jasper, Ontario W. Hansen Trane Ingersoll Rand, La Crosse, Wisconsin, USA S. Lawrence Cisco Systems Video Technology Canada, Inc., Scarb

39、orough, Ontario G. Lundy IBM Canada Limited, Markham, Ontario R. Martel Electro-Federation Canada, Tornto, Ontario S. Michaud Thomas “subclause” means a numbered subdivision of a cl ause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all subclauses of Clause 201.7). References to clauses within this Inter

40、national Standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the condition

41、s is true. The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “

42、should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a p

43、aragraph or table title indicates that there is guidance or a rationale related to that item in Annex AA. The attention of Member Bodies and National Committees is drawn to the fact that equipment MANUFACTURERS and testing organizations may need a transitional period following publication of a new,

44、amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally n

45、ot earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. CAN/CSA-C22.2 No. 80601-2-55:14INTERNATIONAL STANDARD ISO 80601-2-55:2011(E) ISO 2011 All rights reserved 1Medical electric

46、al equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors 1 Scope 201.1 Scope, object and related standards IEC 60601-1:2005, Clause 1 applies, except as follows: 201.1.1 * Scope Replacement: This International Standard specifies parti

47、cular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This International Standard specifies requirements for anaesthetic gas monitoring, carbon dioxide mon

48、itoring, and oxygen monitoring. NOTE 1 An RGM can be either standalone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator. This International Standard is not applicable to an RGM intended for use with flammable anaesthetic agents. Environmental aspects a

49、re addressed in Annex BB. NOTE 2 Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subcla