IEC TR3 60513-1994 Fundamental aspects of safety standards for medical electrical equipment《医用电气设备安全标准的基本方面》.pdf

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1、IEC 513 94 W 4844893 0550544 583 = RAPPORT TECHNIQUE TECHNICAL REPORT CE1 IEC 51 3 Deuxime dition Second edition 1994-01 Aspects fondamentaux des normes de scurit pour les appareils lectromdicaux Fundamental aspects of safety standards for medical electrical equipment Numro de rfrence Reference numb

2、er CEIAEC 51 3: 1994 Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEC 523 94 El Y144892 0550545 4LT Rvision de ia prsente publication Le contenu technique des publications

3、de la C E I est cons- tamment revu par la Commission afin dassurer quil reflete bien ltat actuel de la technique. Les renseignements relatifs ce travail de rvision, ltablissement des ditions rvises et aux mises jour peuvent tre obtenus auprs des Comits nationaux de la CE1 et en consultant les docume

4、nts ci-dessous: Bulletin de la CE I Annuaire de la C E I Catalogue des publications de la C E I Publi annuellement Terminologie En ce qui concerne la terminologie gnrale, le lecteur se reportera la Publication 50 de la CE I : Vocabulaire Electro- technique Intemational (VED. qui est tablie sous form

5、e - ia Publication 617 de la C E I: Symboles graphiques pour schmas. - la Pubiication 878 de la CEI: Symboles graphiques pour quipements lectriques en pratique mdicak. Les symboles et signes contenus dans la prsente publication ont t soit rcpris des Publications 27.617 ou 878 de la CE 1. soit spcifi

6、quement approws aux fins de cette publication. Publications de la C E I tablies par le mme Comitc! dEtudes Lacntion du ledaa est attirt sur le da12me feuille3 de la cowexturc. qui numre ks publications de la CE1 prpares par k Comit dEtudes qui a tabli la prsente publication. Revision of this publica

7、tion The technical content of I E C publications is kept under con- stant review by the I E C. thus ensuring that the content refiects current technology. Information on the work of revision, the issue of revised edi- tions and amendment sheets may be obtained from IEC National Committees and from t

8、he following I E C sources: I E C Bulletin IECYearbmk Catalogue of I E C Publications Published yearly Terminology For general terminology, readers are referred to I E C Publi- cation 50: International Electrotechnid Vocabulary (IEV), which is issued the form of separate chapters each dealing with a

9、 specific field. the General Index being published as a se- parate booklet Full details of the IEV will be supplied on request. The tams and definitions contained in the present publication have either been taken from the IEV or have been specifically approved for the purpose of this publication. Gr

10、aphical and letter symbols For graphical symbols, and letter symbols and signs approved by the I E C for general use, readers are referred to: - I E C Publication 27: Letter symbols to be used in elecmcal technology; - I E C Publication 617: Graphical symbols for diagrams. - EC Publication 878: Grap

11、hical symbols for electrical equipment in medid practice. The symbols and signs contained in the present publication have ather been taken from IEC Publications 27.617 or 878, or have bun spedmy apprwed hthepurpose of thir publica- tion. I E C publications prepared by the same Technical Committee ni

12、e attention of readers is drawn to the back coyer. which lists IEC publications issued by the Tedinical Cornminee which has prepared the present publication. Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitte

13、d without license from IHS-,-,-RAPPORT TECHNICAL TECHNIQUE - TYPE 3 REPORT - TYPE 3 CE1 IEC 51 3 Deuxime dition Second edition 1994-01 Aspects fondamentaux des normes de scurit pour les appareils lectromdicaux Fundamental aspects of safety standards for medical electrical equipment CE1 1994 Droits d

14、e reproduction rservs - Copytight - all rights reserved Auaina patim de type 2, lorsque le sujet en question est encore en cours de dveloppement technique ou lorsque, pour une raison quelconque, la possibilit dun accord pour la publication dune Norme internationale peut tre envisage pour lavenir mai

15、s pas dans limmdiat; type 3, lorsquun comit dtudes a runi des donnes de nature diffrente de celles qui sont normalement publies comme Normes internationales, cela pouvant comprendre, par exemple, des informations sur ltat de la technique. Les rapports techniques de types 1 et 2 font lobjet dun nouve

16、l examen trois ans au plus tard aprs leur publication afin de dcider ventuellement de leur transformation en Normes internationales. Les rapports techniques de type 3 ne doivent pas ncessairement tre rviss avant que les donnes quils contiennent ne soient plus juges valables ou utiles. La CE1 513, ra

17、pport technique de type 3, a t tablie par le sous-comit 62A: Aspects gnraux des quipements utilises en pratique mdicale, du comit dtudes 62 de la CEI: Equipements lectriques dans la pratique mdicale. Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for Re

18、saleNo reproduction or networking permitted without license from IHS-,-,-IEC 513 14 48i4891 0550554 422 513 0 IEC:1994 -9- INTERNATIONAL ELECTROTECHNICAL COMMISSION FUNDAMENTAL ASPECTS OF SAFETY STANDARDS FOR MEDICAL ELECTRICAL EQUIPMENT FOREWORD i) The IEC (International Electrotechnical Commission

19、) 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 fields. To this end and in addit

20、ion 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-governmental organizations liaisin

21、g with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of the IEC on technical matters,

22、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 international use published in the f

23、orm of standards, technical reports or guides and they are accepted by the National Committees in that sense. 4) In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and re

24、gional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. The main task of IEC technical committees is to prepare International Standards. in exceptional circumstances, a technical committee may propose the

25、 publication of a technical report of one of the following types: type 1, when the required 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

26、future but not immediate possibility of an agreement on an Inter- national Standard; 0 type 3, 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

27、subject to review within three years of publication to decide whether they can be transformed into International 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 513, which is a technical rep

28、ort of type 3, has been prepared by sub-committee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo

29、reproduction or networking permitted without license from IHS-,-,-IEC 513 74 5i 4844071 0550555 369 Projet de comit - 10 - 513 0 CEI:1994 Rapport de vote 1 62A(SEC) 136 62A( SEC) 1 48 Le rapport de vote indiqu dans le tableau ci-dessus donne toute information sur le vote ayant abouti lapprobation de

30、 ce rapport technique. La premire dition de la CE1 513: Aspects fondamentaux de la scurit de lquipement lectrique utilis dans la pratique mdicale, a t publie en 1976 et a servi de base au dveloppement de: - la premire et de la deuxime dition de la CE1 601-1 (norme de scurit de base pour les appareil

31、s lectromdicaux); - la srie CE1 601 -1 -xx des normes collatrales pour les appareils lectrorndicaux,et - la srie CE1 601-2-xx des normes particulieres pour des types particuliers dappareils lectromdicaux. Lapproche dorigine de la CE1 tait de prparer des normes spares de scurit. et de * pour faire fa

32、ce aux dangers qui rsulteraient dune conception inadquate des appareils lectromdicaux, beaucoup de normes particulires de la srie CE1 601-2-xx prsentent un ventail de prescriptions de performances essentielles qui ne peuvent pas tre directement values par lutilisateur sans application de telles norm

33、es. (Cependant, la srie CE1 601 actuelle comporte bien moins de prescriptions pour la scurit fonctionnelle que pour la scurit de base.) Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from

34、 IHS-,-,-I IEC 513 94 El 4044891 0550556 2T5 Committee draft 513 0 IEC:1994 -11 - Report on Voting I 62A(SEC)136 I 62A(SEC)148 I 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. The first edition of IEC 513: B

35、asic Aspects of the safety philosophy for electrical equipment used in medical practice, was published in 1976 and provided the basis for developing: - the first and second editions of IEC 601-1 (the parent safety standard for medical electrical equipment); - the IEC 601-1-xx series of collateral st

36、andards for medical electrical equipment, and - the IEC 601-2-xx series of particular standards for particular types of medical electrical equipment. The original IEC approach was to prepare separate “safety“ and “performance“ standards for medical electrical equipment. This was a natural extension

37、of the historical approach taken at the national and international level with other electrical equipment standards (e.g. those for domestic equipment), where basic physical safety is regulated through mandatory standards but other performance specifications are regulated by market pressure. In this

38、context it has been said that, “The ability of an electric kettle to boil water is not critical to its safe use!“ It is now recognized that this is not the situation with many items of medical electrical equipment, and users have to depend on standards to ensure essential performance as well as basi

39、c safety. Medical authorities are equally concerned about the ability of the equipment to perform correctly and the prevention of other hazards. Although the structure and content of the first and second editions of IEC 601-1 were restricted to basic safety issues, increasing clinical involvement in

40、 the preparation of the particular standards confirmed that, for many types of medical electrical equipment, the user has to depend on formal standards to ensure adequate performance as well as basic safety. Such areas include the accuracy with which the equipment controls the delivery of energy or

41、therapeutic substances to the patient, or processes and displays physiological data which will affect patient management. Resulting from this recognition that separating “safety“ and “performance“ is somewhat inappropriate in addressing the hazards which result from inadequate design of medical elec

42、trical equipment, many particular standards in the IEC 601-2-xx series address a range of essential performance requirements which cannot be directly evaluated by the user without applying such standards. (However, the current IEC 601 series includes far less requirements for functional safety than

43、for basic safety). Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IEC 513 IY 4844411 0550557 131 - 12 - 513CEI:1994 II est de plus en plus fortement suggr que toutes les pres

44、criptions concernant la scurit et les performances essentielles des appareils lectromdicaux soient regroupes au sein dun seul jeu de normes internationales. La Directive Europenne propose sur les dispositifs mdicaux souligne aussi le besoin dun seule srie de normes couvrant les prescriptions essenti

45、elles pour lensemble de tels produits. Un historique de la CE1 51 3, 1 re dition et de la srie des CE1 601 figure lannexe E. La prsente deuxime dition de la CE1 513 se propose de servir de guide au dveloppement de la troisime dition de la CE1 601 -1, et au-del du dveloppement des CE1 601 -1 -xx et 6

46、01 -2-xx. Afin de raliser la cohrence des normes internationales, de rpondre aux attentes prsentes de la communaut des soins de sant et dtre en ligne avec les dveloppements des CE1 601 -2-xx, la prsente deuxime dition de la CE1 51 3 comporte deux modifications majeures: - Dans la premire modificatio

47、n, en partant des considrations de scurit de base, simples, de la premire et de la deuxime dition de la CE1 601-1, le concept de sascurit, a t largi pour y inclure le sujet des performances essentielles, (par exemple la prcision des appareils de monitorage physiologique). - Dans la seconde modificat

48、ion, en spcifiant des prescriptions de scurit minimales, une disposition est prise pour valuer ladquation du processus de conception lorsquil fournit une alternative approprie lapplication de lessai en laboratoire avec des critres spcifiques dacceptation ou de refus, (par exemple en valuant la scurit de nouvelles technologies telles que les systmes lectroniques programmables). Cette deuxime dition annule et remplace la premire dition, parue en 1976. Copyright International Electrotechnical Commission Provided by IHS