CAN CSA-C22 2 NO 601 2 10 AMD 1-2004 Amendment 1 Medical electrical equipment – Part 2-10 Particular requirements for the safety of nerve and muscle stimulators (First Edition).pdf
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1、Amendment 1:2004 toNational Standard of CanadaCAN/CSA-C22.2 No. 601.2.10-92Amendment 1:2001 and Corrigendum 1:2002 to International Standard IEC 601-2-10:1987 have been adoptedwithout modification (IDT) as Amendment 1:2004 to CAN/CSA-C22.2 No. 601.2.10-92. At the time ofpublication, Amendment 1:2001
2、 and Corrigendum 1:2002 to IEC 601-2-10:1987 are available from IEC inEnglish only. This Amendment and this Corrigendum were reviewed by the CSA Technical Committee onConsumer and Commercial Products, under the jurisdiction of the Strategic Steering Committee onRequirements for Electrical Safety, an
3、d have been formally approved by the Technical Committee. Due to themedical content of the Standard, the Amendment and Corrigendum were also approved by the TechnicalCommittee on Applications of Electricity in Health Care under the jurisdiction of the Strategic SteeringCommittee on Health Care Techn
4、ology.July 2004Amendment 1Medical electrical equipment Part 2-10:Particular requirements for the safetyof nerve and muscle stimulatorsAmendement 1Appareils lectromdicaux Partie 2-10:Rgles particulires de scuritpour stimulateurs de nerfs et de musclesPRICE CODE IEC 2001 Copyright - all rights reserve
5、dInternational Electrotechnical Commission 3, rue de Varemb Geneva, SwitzerlandTelefax: +41 22 919 0300 e-mail: inmailiec.ch IEC web site http:/www.iec.chJFor price, see current catalogueCommission Electrotechnique InternationaleInternational Electrotechnical Commission 2 60601-2-10 Amend. 1 IEC:200
6、1(E)FOREWORDThis amendment has been prepared by subcommittee 62D: Electromedical equipment, ofIEC technical committee 62: Electrical equipment in medical practice.The text of this amendment is based on the following documents:FDIS Report on voting62D/413/FDIS 62D/420/RVDFull information on the votin
7、g for the approval of this amendment can be found in the report onvoting indicated in the above table.The committee has decided that the contents of the base publication and its amendments willremain unchanged until 2004. At this date, the publication will be reconfirmed; withdrawn; replaced by a re
8、vised edition, or amended.The contents of the corrigendum of January 2002 have been included in this copy._Page 5PREFACEReplace the final two paragraphs of the Preface with the following new text:A rationale for the more important requirements, where appropriate, is given in annex AA. It isconsidere
9、d that a knowledge of the reasons for these requirements will not only facilitate theproper application of the Particular Standard but will, in due course, expedite any revisionnecessitated by changes in clinical practice or as a result of developments in technology.However this annex does not form
10、part of the requirements of this standard.The clauses and subclauses which have corresponding rationale statements are marked withan asterisk (*) before their number.The numbers of the following clauses should be preceded by an asterisk in the main body ofthe text:1.1, 5.2, 5.6, 6.1, 6.8.2 aa), 14.6
11、, 19, 20.2, 46.101, 50.1, 50.2, 51.101, 51.102, 50.103, 51.104,57.360601-2-10 Amend. 1 IEC:2001(E) 3 SECTION ONE GENERALPage 71 Scope and object1.1 ScopeAt the end of the 4thdashed item add: (partly covered by IEC 60601-2-31)At the end of the 7thdashed item add: (covered by IEC 60601-2-40)At the end
12、 of the 8thdashed item add: (covered by IEC 60601-2-40)Add the following subclauses:1.3 Particular StandardsAdd the following new text:This Particular Standard for NERVE AND MUSCLE STIMULATORS is to be read in conjunction withthe following standard:IEC 60601-1:1988, Medical electrical equipment Part
13、 1: General requirements for safetyAmendment 1 (1991)Amendment 2 (1995)The requirements of this Particular Standard take priority over the above-mentioned standardand its amendments, hereinafter referred to as the General Standard.1.5 Collateral StandardsAdd the following new text:The following Coll
14、ateral Standards apply:IEC 60601-1-1:2000, Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systemsIEC 60601-1-2:1993, Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard: El
15、ectromagnetic compatibility Requirements and testsIEC 60601-1-4:1996, Medical electrical equipment Part 1: General requirements for safety 4. Collateral Standard: Programmable electrical medical systemsAmendment 1 (1999) 4 60601-2-10 Amend. 1 IEC:2001(E)Page 92.1.102 Pulse durationReplace “waveform”
16、 by “WAVEFORM”.2.1.103 WaveformReplace “the APPLIED PART“ by “a PATIENT CIRCUIT“.4 General requirements for tests4.1 Item b)Delete 4.1, Item b.Add the following new text:4.6 Additional Item:aa) Where reference is made in test specifications to electrode cables and/or electrodes,those supplied or rec
17、ommended by the manufacturer shall be used.5 Classification5.1 Amendment:Delete subclause 5.1.5.2 Amendment:Replace “TYPE B EQUIPMENT“ by “TYPE B APPLIED PART“.6 Identification, marking and documents6.1 Marking on the outsideReplace the existing title with “Marking on the outside of EQUIPMENT or EQU
18、IPMENT parts“.6.1 j) Power inputReplace “MAINS OPERATED“ by “mains operated“.6.1 p) OutputReplace “Appendix D“ by “Appendix D, Table DI“.60601-2-10 Amend. 1 IEC:2001(E) 5 Page 116.8 Accompanying documents6.8.2 Instructions for useItem aa) e):Add the following new dashed item: Application of electrod
19、es near the thorax may increase the risk of cardiac fibrillation.7 Power inputReplace, on page 13, first line, the numbering of subclause “7.3“ by “7.1“.Page 13SECTION TWO SAFETY REQUIREMENTSChange title to “SECTION TWO ENVIRONMENTAL CONDITIONS”.SECTION THREE PROTECTION AGAINST ELECTRICSHOCK HAZARDS
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