1、CAN/CSA-C22.2 No. 80601-2-61:14Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment(ISO 80601-2-61:2011, MOD)CAN/CSA-C22.2 No. 80601-2-61:14(ISO 80601-2-61:2011, MOD)National Standard of Canada ISO 2011. CSA Group 2014
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21、 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 suitabi
22、lity 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 CanadaPub
23、lished 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. 80601
24、-2-61:14Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment(ISO 80601-2-61:2011, MOD)Reviewed byApproved byCAN/CSA-C22.2 No. 80601-2-61:14Medical electrical equipment Part 2-61: Particular requirements forbasic safety
25、 and essential performance of pulse oximeter equipmentCSA/4 2014 CSA Group March 2014CAN/CSA-C22.2 No. 80601-2-61:14Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment(ISO 80601-2-61:2011, MOD)CSA PrefaceThis is the f
26、irst edition of CAN/CSA-C22.2 No. 80601-2-61, Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standard
27、ization) Standard 80601-2-61 (first edition, 2011-04-01). It replaces the previous edition, published in 2007 as CAN/CSA-Z9919, Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (adopted ISO 9919:2005). For
28、 brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 80601-2-61” 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 60601-1:20
29、05, 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 Strategi
30、c 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 Committ
31、ee 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. 80601-2-61:14Medical electrical equipment Part 2-61: Particular requirements forbasic safety and essential performance of pulse oximeter
32、 equipmentCSA/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 accordance with CSA
33、 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. 80601-2-61 shall be replaced by the relevant N
34、ational 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 the latest e
35、ditions 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.201.4.1AAdd t
36、he 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-Chair Repre
37、senting 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, Mississa
38、uga, 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., Scarborough, On
39、tario G. Lundy IBM Canada Limited, Markham, Ontario R. Martel Electro-Federation Canada, Tornto, Ontario S. Michaud Thomas the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a
40、 problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical,
41、including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ii
42、 ISO 2011 All rights reservedCAN/CSA-C22.2 No. 80601-2-61:14ISO 80601-2-61:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword vi Introductionviii 201.1 Scope, object and related standards1 201.1. 1 * Scope1 201.1. 2 Object1 201.1. 3 Collateral standards 2 201.1. 4 Particular standards 2
43、201.2 Normative references.3 201.3 Terms and definitions 4 201.4 General requirements 8 201.4. 3 ESSENTIAL PERFORMANCE.8 201.4. 101 * Additional requirements for ESSENTIAL PERFORMANCE .8 201.4. 102 Additional requirements for acceptance criteria 9 201.4. 103 Additional requirements for PULSE OXIMETE
44、R EQUIPMENT, parts and ACCESSORIES .9 201.5 General requirements for testing of ME EQUIPMENT9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.10 201.7 ME EQUIPMENT identification, marking and documents .10 201.7. 2.3 Consult ACCOMPANYING DOCUMENTS .10 201.7. 2.9 IP classification10 201.7. 2.101
45、Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts10 201.7. 2.4.101 Additional requirements for ACCESSORIES.11 201.7. 2.13.101 Additional requirements for physiological effects11 201.7. 2.17.101 Additional requirements for protective packaging11 201.7. 4.3 Unit
46、of measure12 201.7. 9.1 Additional general requirements12 201.7. 9.2.1.101 Additional general requirements12 201.7. 9.2.2.101 Additional requirements for warnings and safety notices 13 201.7. 9.2.8.101 Additional requirements for start-up PROCEDURE13 201.7. 9.2.9.101 Additional requirements for oper
47、ating instructions 13 201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used material .14 201.7. 9.3.1.101 * Additional general requirements .14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT15 201.8. 3.101 Additional requirements for classification o
48、f APPLIED PARTS15 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS.15 201.10 Protection against unwanted and excessive radiation HAZARDS .15 201.11 Protection against excessive temperatures and other HAZARDS .15 201.11. 6.5.101 * Additional requirements for ingress of water
49、 or particulate matter into ME EQUIPMENT or ME SYSTEM .16 201.11. 8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT 16 201.11. 8.101.1 Supply failure TECHNICAL ALARM CONDITION 16 201.11. 8.101.2 Settings and data storage following short interruptions or automatic switchover .16 201.11. 8.101.3 Opera
