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

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 At this date, the publication will be reconfirmed; withdrawn; replaced by a re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

20、14 Requirements related to classification14.3 Class III equipmentDelete subclause 14.3.14.4 Item a)Delete subclause 14.414.6 Replacement:In the text replace “STIMULATORS shall be TYPE BF or CF EQUIPMENT“. by “THE APPLIED PARTS ofSTIMULATORS shall be TYPE BF or TYPE CF APPLIED PARTS“.20 Dielectric st

21、rength20.3 Values of test voltagesIn the text, on page 15, replace “EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE“ by“INTERNALLY POWERED EQUIPMENT“. 6 60601-2-10 Amend. 1 IEC:2001(E)SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTEDOR EXCESSIVE RADIATIONS36 Electromagnetic compatibilityRepla

22、ce the existing text by:Replacement:IEC 60601-1-2 applies except as follows:36.201 EMISSIONS36.201.1 Radio-frequency (RF) EMISSIONS36.201.1.7 Replacement:For the radiated radio-frequency emissions test, all relevant electrodes shall be connected andapplied to the contents of a 1 000 ml capacity norm

23、al saline-filled phantom, positioned within400 mm of the EQUIPMENT (see figure 101).36.202 IMMUNITY36.202.2 Radiated radio-frequency electromagnetic fields36.202.2.1 RequirementsItem a)Replace the text of this item by the following:For radiated radio-frequency electromagnetic fields, the EQUIPMENT a

24、nd/or system shall: continue to perform its intended function as specified by the manufacturer at a level up to3 V/m for the frequency range of 26 MHz to 1 GHz, and continue to perform its intended function as specified by the manufacturer or fail withoutcreating a safety hazard at levels between 3

25、V/m and 10 V/m for the frequency range of26 MHz to 1 GHz.36.202.2.2 Test conditionsItem d)Replace the text of this item by the following:For the radiated radio-frequency electromagnetic field test, all relevant electrodes shall beconnected and applied to the contents of a 1 000 ml capacity normal sa

26、line-filled phantom,positioned within 400 mm of the EQUIPMENT (see figure 101).60601-2-10 Amend. 1 IEC:2001(E) 7 Page 19SECTION SIX PROTECTION AGAINST HAZARDS OF EXPLOSIONSIN MEDICALLY USED ROOMSChange title to “SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OFFLAMMABLE ANAESTHETIC MIXTURES”.SEC

27、TION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES,FIRE AND OTHER HAZARDS, SUCH AS HUMAN ERRORSChange title to “SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURESAND OTHER SAFETY HAZARDS”42 Excessive temperaturesThis clause of the General Standard applies except as follows:Amend the complianc

28、e test for the requirements of subclauses 42.1 to 42.3 as follows:5) Test criteriaAdditional third paragraph:Compliance with the requirements for maximum temperatures specified in the GeneralStandard shall be checked under the conditions specified in Item aa) of subclause 7.1.Page 21SECTION EIGHT AC

29、CURACY OF OPERATING DATA AND PROTECTIONAGAINST INCORRECT OUTPUTIn the title, replace “INCORRECT” by “HAZARDOUS”.51 Protection against incorrect outputIn the title, replace “incorrect” by “hazardous”.Page 2351.104 Limitation of output parametersItem a):Replace twice, in the last paragraph, “output ci

30、rcuit(s)“ by “PATIENT CIRCUIT(S)“.Item b)Delete “For other diagnostic applications, the limits for the output parameters are underconsideration”. 8 60601-2-10 Amend. 1 IEC:2001(E)SECTION NINE FAULT CONDITIONS CAUSING OVERHEATING AND/ORMECHANICAL DAMAGE; ENVIRONMENTAL TESTSChange title to “SECTION NI

31、NE ABNORMAL OPERATION AND FAULT CONDITIONS;ENVIRONMENTAL TESTS”SECTION TEN CONSTRUCTIONAL REQUIREMENTS57 MAINS PARTS, components and layout57.3 Mains supply cables or cordsChange title to “POWER SUPPLY CORDS”Page 24Replace the existing Figure 101 with the new Figure 101: 400 mmEquipmentRecording and

32、stimulation electrodes1 000 mlWooden tableIEC 316/98Figure 101 Layout of testing arrangements (see 36.201.1.7 and 36.202.2.2d)Page 25Delete Figure 102.Page 26Delete Figure 103.60601-2-10 Amend. 1 IEC:2001(E) 9 Page 29Replace the entire page by the following:Appendices A to L of the General Standard

33、apply.APPENDIX L References Publications mentioned in this standardAdd the following references:IEC 60601-2-31:1994, Medical electrical equipment Part 2-31: Particular requirements for thesafety of external cardiac pacemakers with internal power sourceIEC 60601-2-40:1998, Medical electrical equipmen

34、t Part 2-40: Particular requirements for thesafety of electromyographs and evoked response equipmentPage 31APPENDIX AA RationaleAA.5 ClassificationDelete subclause AA.5.1.AA.6 Identification, marking and documentsAA.6.8.2 aa)Item e)Delete second dashed item.Delete dash at start of first dashed item.

35、Page 33Delete subclause AA.14.3.AA.19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTReplacement:Following the definitions in the General Standard, the therapeutic current flowing between theelectrodes of a STIMULATOR through the PATIENT is neither a PATIENT AUXILIARY CURRENT nor aPATIENT

36、LEAKAGE CURRENT, but a functional current.AA.36 Electromagnetic compatibilityReplacement:The tests using the normal saline-filled phantom (see 36.201.1.7 and 36.202.2.2) are derivedfrom IEC 60601-2-40. Normal saline is standard physiological saline: 0,9 % or 9 g/L or 0,15 M._February 2002IEC 60601-2

37、-10 amend. 1(First edition 1987)Medical electrical equipment Part 2-10: Particular requirements for thesafety of nerve and muscle stimulatorsAmendment 1CORRIGENDUM 1Page 742 Excessive temperaturesReplace the existing Clause 42 as follows:42 Excessive temperaturesThis clause of the General Standard a

38、pplies except as follows:Amend the compliance test for the requirements of subclauses 42.1 to 42.3 as follows:5) Test criteriaAdditional third paragraph:Compliance with the requirements for maximum temperatures specified in the General Standardshall be checked under the conditions specified in Item aa) of subclause 7.1.ICS 11.040.60PRINTEDINCANADAIMPRIMEAU CANADA