1、CAN/CSA-C22.2 No. 601.2.10-92 (lEG 601-2-10:1987) (Reaffinned 1997) Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators A National Standard of Canada sJa.ijn)pJod uiosaq sa uapuo awiou osia5nfapinos.:,qn,j , eqwoui/nb4uaai ap uoiodwj uopzxjjddo
2、,p aujowoj anbpqnj DS snosuouayosawJou aauods.inJajwwdinq ajanb uajg s a5pnfo siasn atpjo /fl.q!suodsJ aLp UIOWa1flDLfl 9OU O uiodwj s ado si uipaos sipiopuo sjtpjo uopw.qddoAiowudpapuau.i atp q6noqy as!e16ue a asie5ue.ij SUO!SJaA ua saqnd uos epeurj np sateuoieu sauou sai ipuaJj pue qI6u U! paqsqnd
3、 ae epeurj jo spepue IUO!N epurj LN9 d IN OUO eMe1:o oozL neain iouuoj, aru oozi !S QS JOUUOJ, ci sawou sap uapeue asuoj epeuej jo iouno spiepue ne aqwou! pCUJ np saieuo!22u SWJON saainojdde,p qesuodsa e- aq ipv ssai epeuj o spipue eUOeN 6u!Aoidde auj aed.id e,i !flb awsue6.io, ap sjdne awiou ei ap
4、aua snid i uop,Iwnxud as ap nswin xne puewwoai sa I! onb.inod sanbpod suawxa,p 2aqo, uo saauou saj q!ssod sa asoip ej nbs.ioi epeuej np seuoeu sauuoN sap iias as ap saiwou ap U!OSaq WO nb sauuosiad xn puewwoa.i sa 1I.pJDDe saw.iou ap napepai awsue6Jo,I ap .qesuodsai ej ainawap padse awjou e ap anbui
5、pa padse,i ns sd aiod au uoeqo.idde, sawjou sap uaipeue !asuo ai .ied sijq sa.iw a sapoipw xne aauouo sa a,ia,nb anbipu! cpeu np aieuoeu awJo anb ue ua awiou aun,p uowqo.idde, Iuo!:eu 2J2U!,I uruioddo sdwa ua aqpdde uopnqnuo aun iaiiodde nad nb awiou aun,p uawaiwu6 6e,s 6esvua auewop aj uojas sassaJ
6、u! sauuosiad sajne a sinaewwosuo sjnaesjn sjnapnpod sap a.iqj!nb uouasida.i aun aqssod snid ai 6ap ne uawioj suni siu sai wop sa2uadwoD sauuosiad ap wqwou ueiia Ufl,p ariA ap s2u!od saj !LWed aqeuuosiw auaua aun ajai !nb sauuou sap uapeue !asuoj ai ainwdd awiou aun sa epeurj np aieuoeu awioj au uo!:
7、tes!Ielwou et ap auiewop ai sup aIeuo2ewau! uo2eJdooD i JasiioAe.j ap a Iuowa2u! a euoeu aiawwoD at Jatp.j ap JnawwosuoD at Ja62oid ap ia Jap!e,p qnd np aa-uaq a, a iros e ues ei JJO!IWe1p aeuoieu awouo JaJOW,p UGXOW awwo a.i!uoIoA uowseuuou e J!oAnowoJd ap a Ja6elnoDua,p uos asuoj np sjnq xndpuid s
8、a teuo!:wu J2U!,t suep aJ!:IuOIOA uoesqewiou ap uoIeJo!Iwe,t 2a uawaddoIaip n uafleAe.n nb sawouon a stuepuadpu! sawsiue6io,p uoijpj aun sajeuojeu sawiou ap awsis np uoIeu!pJooD ap awsue6Jo,I isa sauuou sp uaipeu asuo a p.iepues aq 6uiedaid uoiezue6.io aq wo.tj uoppa sae aq ucqo o pauon a.ie siasn w
9、oaiaq M!AW pOUad o palqns a spiepues asauj aqepwd JaMuaq,v epeuej JO SPJPUS IUON asn o pa6e.inoDua a.ie spiepueis Xdd o paau e aieq oqM asouj uo!2z1.ue6Jo uawdoIaAap-spjpues paipan aqjo Xqsuodsa.i 6unuuoD aip su!ewa.i sq ppus aqo uauo Ie!uLPa aq oiaa.i ou saop eAoiddv epeueD JO IPUflOD SPJCPUC2S aip
10、 Xq paqsqeisa sainpaxud pue eiax aq o swaouo p.epues e ip sae!pu! epeurj o ppue UON e w piepueis e o eAoiddy saau IUO!U aip o uopnqnuo Aawi pue 2uepu6s 6upew o aqede s IP!IIM p.ipues s Xeiwou pueq u pafqns aqi o aeudoidde aq iCew se sjsa.ia2u ueiaai IP!M sJa1fo pue tJawnsuoD siasn sianpod jo uouasai
11、da.i o aue,eq uaxa aqep.id ,sacw6 aq o ap!Aaid slsaJa2uI apao asoq sJcnpAIpu! aqede jo .iaqwnu e jo siva aq 6uowc uawaai6 aqeuoseai c spajai LpIqM auo pu epeue o punoj sppu aip Xq paAoJdd uaaq sq ip!qi piepues Si CU) o pipue CUO!N v spJepuesjo pa aq U! UOJdOO) euoewau 6uiaipin pue api Iuoewau! puc i
12、sawop 6uepe awnsuo aip 6upao.id pue 6uisss ,qnd aipo aieja pu aes qaq aqt 6ujauaq iwouoa euoeu aip 6upueip o sueaw e se uozppus unoi aowoid pu aisoj o we punoj aqi o spaiqo dpuud auj 1saJau! euojeu aq Ut UO1eZ1pJePUeS (ieunoi jo wawaAwdw pue 2uawdoaAap aqpn aq SJMO 6uppoM UOZU6JO snowouajne uapuadap
13、u! o uorjejapj e was sp.iepue IUON aqi o Xpoq 6uu!pJooD aq si puv Jo UflO) papi auj epcuej EJLM6V1 o!JeuO OUOiOj 1YNOI1YN31NI YSO a,epxaj piAaJnoq BLL pieanog aepxaj SLL , ieuoewaui ys) Jassaipe,s ys) ei ap saD!.as Sj Jfls s2uawau6!asuai saidwe snid JflOd O JM saiiuas yj uo uoauou aqnj oj aeuoewaui,
14、nb aiuoeu s2uap sou ap suosaq xne aipuod.i .inod saijne a uoejtpa ap uosewiou ap saiis.iasap aJ!e!puua2u!,IJd sax sas a epos a6s uos atn .vsD anbjew e :tue:tjod snpojd sap uo!padsu!,I a uawxa,I anuquo a aJ!tfl6J uo5e ap apxiid uoiepossy, uoejgiaD ap snssaxud uos ap J6u!,I ansse J!UeW a sauuou ap uoo
15、qe, ap auiewop a suep sAge sas ua3dwoD a ua!ndde !nb !essa,I asw ap a uowpiaD ap saD!Mas sap a.ujo uoepossy, J!UOtOA UOSUiJOU J uanos ap saias sai nod nuaaj ap auJodw! a.inos aun 2uauas.ida.i uanos ap sa.iqwaw sap suowspo sai ssoip uos s.ina2wsuwpe sas sanbsa wid yj ap sa.iqwaw sap aqwasua, 2uanisuo
16、D uajnos ap saJqwaw yyj sa a swo sap ap.ied uese SaJ!UOjOA 000L anbanb sa uapnos ap saiqwaw ap uoeso s.ina sjpa1qo sas ueXndde ua a Ys) I ap swo sap XneAC.Q xn 2uedp.ied ua yj eed uaw uoesewiou ap I!AJ2 n indde ina ap uau6!ow sXed np a.ww, noq un,p suapcur sa iuawauuoiAua1 ap a uoprtsuo e ap uawq np
17、 WnDs e, ap us I ap 5U!eWOp sa suep uawa1!InDpJd a2uwnoD asoip sa epanb IPU!A0Jd a edpiunw uoesi6 ap sa.ip.io siap uodope dna, a aiiawwoD a a apsnpui, suep anpuedi si sa j saituou sap uoiesin,i aeiuawawaino6 saua6e,p a sauuo!ssaoJd stho ap se!PuXs ap sjueuas.idw sap a sueII!ep sap sjnaewwosuoD sap u
18、eiqe sap uaino.q as spnbsap a.iqwou ne shed ne noied ap sia6esn,p a sinapnpojd ap snsuasuo at uajai vs sauuou sa- uowjpjaD a sawiou ap uowoqe, ansuo as aa uocuawa6i ap ioinod !u jwn nq sues wq uo!WJJ,p uoepossy EL6 I ua sawiou sap uaIpeuD I!asuoD a ed saeuoeu sawaou ap awsXs np uias n uorep.oe uos a
19、 6L6 I. ua sauad sa.qja sas n5ai e ajedjd ajeuoeu awio aa a,ianbei ap saldsne sa snos (w) iuocicwaiuu wou a snos anuuo uuuuuw uogsipuuou ap auuaqcu uogposs,-j spaau iUOWaU! pue iuou :aaw o:i saDvuas pajaJ pue uoggia 5pJepUS jo asn aqi q6noiip sa!Aas pue spoo6 jo a6uapxa aq 6ugegpe sape jo wnjo a,ipa
20、jp pue uado uc apAoJd o Si UO!5S!W asoq uoziuthio ai,uas uapuadapu! u si j :uo!ssw awodioD s aaw o asp.adxa Aiessaau aip padoaAap seq uopeposs aq 616 L au!S saiunoD q6ia u sapua6e 6uisa2 pue uopDadsul puc cpeuej sso.oe sazua oIcw ui sajo tpu.iq euo!6aJ seq yj ouo.ioi u xadwoD Xioejoqq pue ajo peaq s
21、 o uogppe u, pev yj aqeaq eip spnpoid spadsu pue spne XenuuoD pue 4en6a.i uoepossy aq ssao.id uojpa s o Xi6aui aq a.insua oj sapip 2uawdolaAap spiepuis s o uolsua2xa ue se pu o .ioddns U! saD!AJas 6upsa2 pue uoDjgia siajjO uoeposs auj sa!A!pe uawdoaAap spiepus s,y-j awoDul o aunos iofew 2uasa.ida.i
22、sd!qsiaqwaw 6u!u!esnS uasoip aie sioPaJ!a S Ip!qM WOLJ diqsiaqwaw io svs wjo4Jaqa6o2 sdqsiaqwaw 6u!uleisns 000Z alfl pu sJaa2unoA aaiwwo 000L ueq wow auj sdqsiaqwaw 6uuesns q6no.iip saipaqo s,uoepossr aip 6uiioddns pu )fJOM aiwwoj j O Sj5 pu awIJ!aq 6uuaa2unoAiq uawdoIaAap spiepueis s,ysJJo41JoddnsJ
23、!aq aeD!pu! epeu sson suoposse pue sa!uedwO) enppu iuawuwi/ua aq pu uopruisuoD pue 6u!p!flq ajes qeaq jo sria aq u 4erog.ied suojqn6a.i iaq u suawwaAo6 e.iapaj pue ieputod ledo!unw ,cq padope uajo puc aaiawwo pue Aiisnpui q Aapii pasn a sp.iepus au,j sapua6e 2uawwaAO6 pue suowziue6io Ieuo!ssaYxd pu
24、suoun siapeai siawnsuoD siainpejnuew u!pnpu! s.iasn pue sianpo.id o snsuasuo ieuou e pajai spiepues j saqA!pc uoepi.iaD pu 2uawdoaAap sp.ipus ui pa6e6ua uojeposs d!qsiaqwaw XJeWnoA (iortieisuou i.joid-ioj-ou s L61 ui was spiepue iuoi aip o epwrj o punoj spiepue aip i(q papa.zxe pu 6L61 u paai.ap 5CM
25、 panpoid uaaq seLl p.epues uoIeN n saidsnc asoqapun (wa) iuocwwawi awu ipiapun swdo ipppvi uopcposs spapues uweu aqj. General Instruction No. 2 CAN/CSA-C22.2 No. 601.2.10-92 October 1992 CSA Standard CAN/CSA-C22.2 No. 601 .2.1 0-92, Medical Electrical Equipment Part 2: Particular Requirements for th
26、e Safety of Nerve and Muscle Stimulators, was published in August 1992: it consisted of 32 pages (15 preliminary and 1 7 text). Errata to the Editorial Changes to Appendix AA and to the Technical Deviation to Subclause 6.8.2 have been incorporated (and identified by a vertical line in the margin) in
27、 the attached replacement pages. CSA Standard CAN/CSA-C22.2 No. 601.2.10-92 now consists of the following pages: lx, xlii, xiv and 117 dated August 1992; and xi, xii and xv dated October 1992. These replacement pages are to be inserted into your copy of the Standard; the pages replaced should be kep
28、t for reference. Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Neive and Muscle Stimulators CAN/CSA-C22.2 No. 601.2.10-92 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators Canadian Deviations and Editorial Cha
29、nges Notes: (1) Deviations in the technical requirements of the Particular Standard, initiated by the CSA committee, are indicated by Technical Deviation. (2) Editorial changes in text of the Particular Standard, initiated by the CSA committee, are indicated by Editorial Change. Sub-clause 1.1 Scope
30、 Technical Deviation Replace the existing first paragraph of this Sub-clause with the following text: This Particular Standard specifies requirements for the safety of NERVE AND MUSCLE STIMULATORS as defined in Sub-clause 2.1 .101, hereinafter referred to as EQUIPMENT, having a RATED OUTPUT POWER no
31、t exceeding 500 W and designed to be installed and used in accordance with the Rules of the Canadian Electrical Code, Part!. Editorial Change Add the following text to this Sub-clause: The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No. 601.1, Medi
32、cal Electrical Equipment Part 1: General Requirements for Safety, hereinafter referred to as the General Standard. For the purposes of testing and approving EQUIPMENT covered within the scope of this Particular Standard, the EQUIPMENT must meet the combined requirements, as applicable, of both this
33、Particular Standard and the General Standard. Editorial Change In this Particular Standard, “shall“ indicates a mandatory requirement; “should“ indicates a recommendation, or that which is advised but not mandatory. Editorial Change This ParticularStandard covers only nerve and muscle stimulators us
34、ed for the diagnosis and/or therapy of neuromuscular disorders. Sub-clause 4.1 Type tests and routine tests Editorial Change Due to the publication of the second edition of the Genera! Standard (CAN/CSA-C22.2 No. 601.1), this Sub-clause within the Particular Standard is no longer operative. No longe
35、r applicable, Appendix B has been deleted from the General Standard. I October 1992 XI (Replaces p. xi, August 1992) CAN/CSA-C22.2 No. 601.2.10-92 Sub-clause 5.1 Classification Editorial Change Due to the publication of the second edition of the General Standard (CAN/CSA-C22.2 No. 601.1), this Sub-c
36、lause within the Particular Standard is no longer operative. Delete the IEC Amendment. Class Ill equipment has been deleted from the General Standard. Sub-clause 6.8.2 Instructions for use Technical Deviation Additional Item. aa) The instructions for use shall additionally contain: g. Advice on the
37、preparation of the PATIENT, including skin preparation, and the use of conductive gel (if applicable) to provide effective patient contact. h. Advice on precautions and contraindications, including transthoracic stimulation. Sub-clause 6.8.3 Technical description Technical Deviation Additional Item.
38、 bb) The technical description shall additionally give: a. The polarity of the output (where applicable). b. The maximum output charge per pulse and maximum average current across a 500 ohm resistive load and at the maximum output setting. c. A graphical representation of typical output signals, sho
39、wing voltage and current waveforms, at half and full settings of the output control when the EQUIPMENT is operating in an open-circuit load condition and the EQUIPMENT is connected to resistive loads of 200 ohms, 500 ohms, 1000 ohms and 2000 ohms. Sub-clause 7.3 Power input Editorial Change The publ
40、ication of the second edition of the General Standard (CAN/CSA.C22.2 No. 601.1) has necessitated the following change to this Sub-clause in the Particular Standard. The Amendment to Sub-clause 7.3 should refer to Sub-clause 7.1 Item a). Sub-clause 7.3 is no longer used in the General Standard. Sub-c
41、lause 14.3 Editorial Change Due to the publication of the second edition of the General Standard (CAN/CSA-C22.2 No. 601.1), this Sub-clause within the Particular Standard is no longer operative. This Sub-clause is no longer used. Class Ill equipment has been deleted from the General Standard. xii Oc
42、tober 1992 (Replaces p. xii, August 1992) Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Neive and Muscle Stimulators Section Nine Fault Conditions Causing Overheating and/or Mechanical Damage; Environmental Tests Editorial Change The publication of the second edition
43、 of the General Standard (C4N/CSA-C22.2 No. 601.1) has necessitated the following change to this Section in the Particular Standard. The title has been changed to “Abnormal Operation and Fault Conditions; Environmental Tests“ in the General Standard. Sub-clause 57.3 Mains supply cables or cords Edit
44、orial Change The publication of the second edition of the General Standard (CAN/CSA-C22.2 No. 601.1) has necessitated the following change to this Sub-clause in the Particular Standard. The title has been changed to “Power supply cords“ in the General Standard. Appendices Editorial Change The public
45、ation of the second edition of the General Standard (CAN/CSA-C22.2 No. 601.1) has necessitated the following change to these Appendices in the Particular Standard. Appendix B is no longer used. Appendices C, D, E, F, and G of the General Standard apply. Appendices H and I are no longer used. Appendi
46、x AA Rationale Sub-clause AA5.1 Editorial Change The publication of the second edition of the General Standard (CAN/CSA-C22.2 No. 601.1) has necessitated the following change to this Sub-clause in the Particular Standard. Delete the first sentence. Sub-clause AA14.3 Editorial Change The publication
47、of the second edition of the General Standard (CAN/CSA-C22.2 No. 601.1) has necessitated the following change to this Sub-clause in the Particular Standard. Delete the sentence. October 1992 XV (Replaces p. xv, August 1992) General Instruction No. 1 CAN/CSA-C22.2 No. 601.2.10-92 August 1992 CSA Stan
48、dard CAN/CSA-C22.2 No. 601 .2.1 0-92, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators, consists of 32 pages (1 5 preliminary and 1 7 text). This Standard, like all CSA Standards, is subject to periodic review, and amendments in the form of
49、replacement pages may be issued from time to time; such pages will be mailed automatically to those purchasers who complete and return the attached card.* Some Standards require frequent revision between editions, whereas others require none at all. It is planned to issue new editions of the Standard, regardless of the amount of revision, at intervals not greater than 5 years. Except in unusual circumstances, replacement pages will not be issued during the last year
