CAN CSA-C22 2 NO 80601-2-56-2012 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temper.pdf

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1、Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementCAN/CSA-C22.2 No. 80601-2-56:12(ISO 80601-2-56:2009, MOD)National Standard of CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Le

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35、r purpose.Registered trade-mark of Canadian Standards AssociationReviewed byNational Standard of CanadaPublished in January 2012 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044V

36、isit our Online Store at shop.csa.caPrepared byInternational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-C22.2 No. 80601-2-56:12Medical electrical equipment Part2-56: Particular requirements for basic safety and essential performance of clinical thermometers for bod

37、y temperature CAN/CSA-C22.2 No. 80601-2-56:12Medical electrical equipment Part 2-56: Particularrequirements for basic safety and essential performance ofclinical thermometers for body temperature measurementCSA/4 Canadian Standards Association January 2012CAN/CSA-C22.2 No. 80601-2-56:12Medical elect

38、rical equipment Part2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementCSA PrefaceThis is the first edition of CAN/CSA-C22.2 No. 80601-2-56, Medical electrical equipment Part 2-56: Particular requirements for basic safety

39、 and essential performance of clinical thermometers for body temperature measurement, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-56 (first edition, 2009-10-01). This Standard is intended to be used i

40、n 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 60601-1:2005, with Canadian deviations).This Standard is considered suitable for use for conformity assessment within the stated scope of

41、 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 Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to t

42、he medical content of 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 Stan

43、dards Council of Canada.Interpretations: The Strategic Steering Committee on Requirements for Electrical Safety has provided the following direction for the interpretations of standards under its jurisdiction: “The literal text shall be used in judging compliance of products with the safety requirem

44、ents of this Standard. 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, CSAs procedures for interpretation shall be followed to determine the intended safety principle.”Janu

45、ary 2012 Canadian Standards Association 2012All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they shoul

46、d be interpreted as “this National Standard of Canada”.CAN/CSA-C22.2 No. 80601-2-56:12Medical electrical equipment Part 2-56: Particularrequirements for basic safety and essential performance ofclinical thermometers for body temperature measurementJanuary 2012 Canadian Standards Association CSA/5Inq

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49、oposal for change” in the subject line:(a) Standard designation (number);(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. 80601-2-56:12Medical electrical equipment Part 2-56: Particularrequirements for basic safety and essential performance ofclinical thermometers for body temperature measurementCSA/6 Canadian Standards Association January 2012Canadian deviations201.7.2.1.101 Additional requirements for minimum requirements for marking on ME EQUIPMENT and i