CAN CSA-CEI IEC-1289-1-1998 High frequency surgical equipment - Part 1 Operation (First Edition).pdf

1、Norme nationale du Canada CANICSA-CEIIIEC 1289-1-98 (CEIIIEC 1289-1: 1994) National Standard of Canada Rapport technique inteamtianal CEIlIlEC 1289-1: 1994 (premi2re iidition, 1994-07) adopt - la CEI 417: Synibolcs gruphiqites iilitisoblcs siir IC niatdriel. Index, relei+ er conipilarim des fciiillc

2、s individuelies; - IEC 417: Graphical synibols for use on equip- rwrri. !iids. surrey and conipilurion of rhe single slr LJCIS, - IEC 6 17: Grnphical symbols for diagrams; et pour les appareils ilecrromtkiicaus. - qiiipuiir! iii riiiiical practice. 1EC 878: Grupliicai symbols fur eecrromedicol Thc s

3、j,nihols and sisns contained in the presenr publi- carion have cihcr been taken from IEC 27, IEC 417, IEC 617 ancl/or IEC 878. or have been specifically appro- vcd lor thc purpvse of ths publication. Les syrnboles et signes coiiriius dsna la prsenrc. publi- cation ont il c.otiitiiillcc: which has pr

4、epared the present publ IL.iIl IC 111. LAasociatian canadlenne de normalisation (CSA), sous les auspices de laquells cette Norme nationale a Btd preparde, a requ ses lettres patentes en 1919 et son accreditation au sein du Systbme de nomes nationales par le Conseil canadien des normes en 1973. Assoc

5、iation daffiliation libre, sans but lucrati ni powoir de rdglementation, elle se consacre A IBlabaration de normes et h la certification. Les normes CSA refldtent le consensus de producteurs et dusagers de partout au pays, au nombre desquels se trouvent des fabricants, des consommateurs, des detaill

6、ants et des representants de syndicats, de corps professionnels et dagences gouvemementales. Lutilisation des norrnes CSA est trds r6pandue dans Iindustrie et le commerce, et leur adoption A divers ordres de Idgislation, tant municipal et provincial que fdddral, est chose courante, particulibrement

7、dans les dornaines de la sant8, de la sdcuritd, du bitiment, de la construction et de Ienvironnernent. Les Canadiens dun bout A Iautre du pays temoignent de Ieur appui au travail de normalisation men6 par la CSA en participant Mn6voIement aux travaux des comites de la CSA et en appuyant ses objectif

8、s par leu6 cotisations de membres de soutien. Les quelque 7000 volontaires faisant partie des cornitds et les 2000 membres de soutien constituent Iensemble des rnembres de la CSA parmi lesquels ses administrateurs sont choisis. Les cotisations des membres de soutien reprhsentent une source important

9、e de revenu pour les services de soutien i2 la normalisation volonlairo. LAssociation offre des sewices de certification et de mise Iessai qui appuient et cornplbtent ses activitds dans le dornaine de 18laboration de normes. De manidre A assurer Iint6grit8 de son processus de certification, Associat

10、ion procMde de faGon r6gulihre et continue A Iexatnen et B Iinspection des produits portant la marque CSA. Outre son si social et ses laboratoires B Etobicoke, la CSA posdde des bureaux regionaux dans des centres vitaux parlout au Canada, de rnhe que des agences dinspection et dessai dans huit pays.

11、 Depuis 1919, Iksociation a parfait les connaissances techniques qui lui permettent de remplir sa mission dentreprke, h savoir la CSA est un organisme de services independant don! la mission est doffrir une tribune libre et efficace pour la realisation daclivites facilitant Ikhange de biens et de se

12、rvices par Iintermhdiaire de services de normalisation de certification et autres, pour repondre aux besoins de nos clients, tant A IBchelle nationale quinternationale. The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and

13、accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-prolit, nonstatutory, voluntay membership association engaged in standards development and certification activities. CSA standards reflect a national consensus of producers and users - including m

14、anufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, buildin

15、g and construction, and the environment. supporting the AssMiations objectives through sustaining memberships. The more than 7000 committee voiunteers and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major

16、 source of income for CSAs standards development activities. The Association offers certification and testing services in suppart of and as an extension to its standards development activities. To ensure the integrity of its certification process, the Association regularly and continually audits and

17、 inspects products that bear the CSA Mark, In addition to its head office and laboratory complex in Etobicoke, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has developed the necessary expertise to m

18、eet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certaication and related services to meet national and international needs. For f

19、urther information on CSA services, write to 178, boulevard Rexdale I78 Rexdale Boulevard Individuals, companies, and associations across Canada indicate their support lor CSAs standards development by volunteering their time and skills to CSA Committee work and Four plus amples renseirlnements sur

20、les services de la GSA. sadresser A Association canadienne de normalisatinon Canadian Standards Association Etobicoke, Ontario, M9W 1 R3 Canada Le Conseil canadien des normes est Iorganisme de coordination du Systhme de nomes nationales, une fdddration dorganismes independants et autonomes qui trava

21、illent au d6vdoppement et h Iamdlioration de la normalisation volontaire dans rlinthr6l national. Les principaux buts du Conseil sont dencourager et de promowoir la normalisation volontaire comme moyen damdliorer Idconomie nationale, dambliorer a sante, la skuritd et le bien- cest pourquoi il est re

22、command4 aux ulitisateurs de se procurer IVdition la plus rkente de a norme auprhs de Iorganisme qui Ia prhparbe. Lapprobation dune norme en tant que Norme nationale du Canada indique quelle est conforme aux mbthodes et criti3res this remains the continuing responsibility of the accredited standards

23、-development organization. Thase who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest edition from the organization preparing the standard. La re

24、sponsabilit4 dapprouver Les Normes nationales du Canada incombe au The responsibility for approving National Standards of Canada rests with the Conseil canadien des normes Standards Council of Canada 45, rue OConnor, Bureau 1200 45 OConnor Street, Suite 1200 Ottawa, Ontario, K1 P 6N7 Canada Les nome

25、s nationales du Canada sont publides en versions franpise et anglaise. National Standards of Canada are published in English and French. Bien que ie but premier vise par Celt8 norme soit Bnoncd sous sa rubrique Domain6 dapplication, il est important de retenir quil incombe B Iufilisateur de jugsr si

26、 la nome convienf B ses besoins particuliers. Although the intended primary applicatjon of his Standard is shred in its Scope, it is important to note that it remains the responsibility of the user to judge its suitability for their particular purpose. CANICSA-CEIIIEC 1289-1-98 Appareds d electrochi

27、rurgie Ci courant haMe frkquence - Partie I : Fonctionnemnt CANICSA-CEIIIEC 1289-1 -98 Appareils dellectrochirurgie a courant haute frkquerzce - Partie 2: Fonctionnement Prbface CSA Ce document constitue la premiere edition de la norme CAN/CSA-CEMEC 1289-1 Appareils delectrochirurgie a courant haute

28、 frequence - Partie I: Fonctionnement. I1 sagit de Iadoption, sans modifications, de le rapport technique internationale de la Commission Electrotechnique lnternationale CEI/IEC 1289-1 : 1994 (premiere edition, datee 1994-07). applications de Ielectricite dans le domaine des soins medicaux, sous Iau

29、torite du Comite directeur strategique de normalisation sur la technologie des soins medicaux et a ete approuvee par le Comite technique. Une liste des membres de ces comites est disponible sur demande. Cette norme a ete approuvee comme Norme nationale du Canada par le Conseil canadien des normes. C

30、ette norme a ete revisee en vue de son adoption pour le Canada par le Comite technique CSA sur les Mars 1998 0 Association canadienne de normalisation - 1998 Tous droits rdservBs. Aucune pariie de cette publication ne peut etre reproduite daucune fapn, par un syst$me de r type 2, lorsque le sujet en

31、 question est encore en cours de developpement technique ou lorsque, pour une raison queiconque, la possibilite dun accord pour la publication dune Norme internationale peut etre envisagee pour Iavenir mais pas dans Iimm4diat; type 3, lorsquun cornite d6tudes a reuni des donnees de nature diffkrente

32、 de celles qui sont normalement publiees comme Normes internationales, cela pouvant cornprendre, par exemple, des informations sur Ietat de la technique. tes rapports techniques de types 1 et 2 font lobjet dun nouvel examen trois ans au plus tard apres leu! publication afin de decider eventuellement

33、 de leur transformation en Normes internationajes. tes rapports techniques de type 3 ne doivent pas necessairement etre r6visks avant que les donnees quils contiennent ne soient plus jugees valables ou utiles. La CEI 1289-1, rapport technique de type 3, a ete etablie par le sous-comite 62A: Aspects

34、g6nBraux des equipements Blectriques utilisks en pratique medicale, du cornit6 dktudes 62 de la CEI: Equipements electriques dans la pratique medicale. 1289-1 O IEC:1994 -5- INTERNATIONAL ELECTROTECHNICAL COMMISSION HIGH FREQUENCY SURGICAL EQUIPMENT - Part 1 : Operation FOREWORD 1) The IEC (Internat

35、ional Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international cooperation on all questions concerning standardization in the electrical and electronic

36、 fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-g

37、overnmental organizations liaising with the t EC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (EO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements

38、of the IEC on technical matters, prepared by technical committees on which all the National Committees having a special interest therein are represented, express, as nearly as possible, an international consensus of opinion on the subjects dealt with. 3) They have the form of recommendations for int

39、ernational use published in the form of standards, technical reports or guides and they are accepted by the National Cornmiltees in rhar sense. 4) In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent

40、 possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national: or regional standard shall be clearly indicated in the latter. 5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equi

41、pment declared to be in conformity with me of its standard. The main task of IEC technical committees is to prepare International Standards. In exceptional circumstances, a technical committee may propose the publication of a technical report of one of the following types: type 1, when the required

42、support cannot be obtained for the publication of an International Standard, despite repeated efforts; type 2, when the subject is still under technical development or where for any other reason there is the future but not immediate possibility of an agreement on an International Standard; 0 type 3,

43、 when a technical committee has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. Technical reports of types 1 and 2 are subject to review within three years of publication to decide whether they can be transformed

44、into lnternational Standards. Technical reports of type 3 do not necessarily have to be reviewed until the data they provide are considered to be no longer valid or useful. IEC 1289-1, which is a technical report of type 3, has been prepared by sub-committee 62A: Common aspects of electrical equipme

45、nt used in medical pratice, of IEC technical committee 62: Electrical equipment in medical practice. . . -6- Le texte de ce rapport technique est issu des documents suivants: I Projet de code 1 Rapport de vote 1 1289-1 O CEl : 1994 Le rapport de vote indique dam le tableau ci-dessus donne toute info

46、rmation sur le vote ayant abouti a Iapprobation de ce rapport technique. 1 I Le present rapport est destine a servir de guide au personnel charge de faire fonctionner les appareils couverts par la CEI 601-2-2 dans les meilleures conditions de securitB pour leurs patients ainsi que pour eux-rngrnes.

47、1 I 1289-1 O 1EC11994 Committee draft Report an voting 62A SE C f 1 2 1 62A(SEC)134 i -7- Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table I I This report gives guidelines to personnel in charge of operation of

48、 equipment covered by IEC 601-2-2 to enable them to attain the best conditions of safety for their patients and themselves. I I -8- 1289-1 O CEI 11 994 1 APPAREILS DELECTROCHIRURGIE A COURANT HAUTE FREQUENCE - Partie 1 : Fonctionnernent Dornaine dapplication Le present rapport technique contient des

49、 directives pour assurer de fason sfire et efficace fes operations de fonctionnement et de maintenance des APPAREILS DLECTROCHIRURGIE A COURANT HAUTE FREQUENCE definis a Iarticle 3 ci-apres, devant - skurite de Iinstatlation; - s0ret6 dutjlisation, qui depend Bgalernent: de la disponibilite et de la lisibilite des documents daccompagnement, de la connaissance quont ies operateurs des caracteristiques de - safety in the installation; - safe use, which again depends on: availability and readability of a