1、INTERNATIONALSTANDARDIEC60601-2-7Second edition1998-02Medical electrical equipment Part 2-7:Particular requirements for the safety ofhigh-voltage generators of diagnosticX-ray generatorsAppareils lectromdicaux Partie 2-7:Rgles particulires de scurit pour gnrateursradiographiques de groupes radiognes
2、 de diagnosticNumro de rfrenceReference numberCEI/IEC 60601-2-7:1998 (E)Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-Numros des publicationsDepuis le 1er janvier 1997, les pu
3、blications de la CEIsont numrotes partir de 60000.Publications consolidesLes versions consolides de certaines publications dela CEI incorporant les amendements sont disponibles.Par exemple, les numros ddition 1.0, 1.1 et 1.2indiquent respectivement la publication de base, lapublication de base incor
4、porant lamendement 1, et lapublication de base incorporant les amendements 1et 2.Validit de la prsente publicationLe contenu technique des publications de la CEI estconstamment revu par la CEI afin quil reflte ltatactuel de la technique.Des renseignements relatifs la date dereconfirmation de la publ
5、ication sont disponibles dansle Catalogue de la CEI.Les renseignements relatifs ces rvisions, ltablis-sement des ditions rvises et aux amendementspeuvent tre obtenus auprs des Comits nationaux dela CEI et dans les documents ci-dessous: Bulletin de la CEI Annuaire de la CEIAccs en ligne* Catalogue de
6、s publications de la CEIPubli annuellement et mis jour rgulirement(Accs en ligne)*Terminologie, symboles graphiqueset littrauxEn ce qui concerne la terminologie gnrale, le lecteurse reportera la CEI 60050: Vocabulaire Electro-technique International (VEI).Pour les symboles graphiques, les symboles l
7、ittrauxet les signes dusage gnral approuvs par la CEI, lelecteur consultera la CEI 60027: Symboles littraux utiliser en lectrotechnique, la CEI 60417: Symbolesgraphiques utilisables sur le matriel. Index, relev etcompilation des feuilles individuelles, et la CEI 60617:Symboles graphiques pour schmas
8、.Publications de la CEI tablies par le mme comit dtudesLattention du lecteur est attire sur les listes figurant la fin de cette publication, qui numrent lespublications de la CEI prpares par le comitdtudes qui a tabli la prsente publication.* Voir adresse site web sur la page de titre.NumberingAs fr
9、om 1 January 1997 all IEC publications areissued with a designation in the 60000 series.Consolidated publicationsConsolidated versions of some IEC publicationsincluding amendments are available. For example,edition numbers 1.0, 1.1 and 1.2 refer, respectively, tothe base publication, the base public
10、ationincorporating amendment 1 and the base publicationincorporating amendments 1 and 2.Validity of this publicationThe technical content of IEC publications is kept underconstant review by the IEC, thus ensuring that thecontent reflects current technology.Information relating to the date of the rec
11、onfirmation ofthe publication is available in the IEC catalogue.Information on the revision work, the issue of revisededitions and amendments may be obtained fromIEC National Committees and from the followingIEC sources: IEC Bulletin IEC YearbookOn-line access* Catalogue of IEC publicationsPublished
12、 yearly with regular updates(On-line access)*Terminology, graphical and lettersymbolsFor general terminology, readers are referred toIEC 60050: International Electrotechnical Vocabulary(IEV). For graphical symbols, and letter symbols and signsapproved by the IEC for general use, readers arereferred
13、to publications IEC 60027: Letter symbols tobe used in electrical technology, IEC 60417: Graphicalsymbols for use on equipment. Index, survey andcompilation of the single sheets and IEC 60617:Graphical symbols for diagrams.IEC publications prepared by the same technical committeeThe attention of rea
14、ders is drawn to the end pages ofthis publication which list the IEC publications issuedby the technical committee which has prepared thepresent publication.* See web site address on title page.Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo
15、 reproduction or networking permitted without license from IHS-,-INTERNATIONALSTANDARDIEC60601-2-7Second edition1998-02Medical electrical equipment Part 2-7:Particular requirements for the safety ofhigh-voltage generators of diagnosticX-ray generatorsAppareils lectromdicaux Partie 2-7:Rgles particul
16、ires de scurit pour gnrateursradiographiques de groupes radiognes de diagnosticCommission Electrotechnique InternationaleInternational Electrotechnical CommissionPour prix, voir catalogue en vigueurFor price, see current catalogue IEC 1998 Droits de reproduction rservs Copyright - all rights reserve
17、dAucune partie de cette publication ne peut tre reproduite niutilise sous quelque forme que ce soit et par aucunprocd, lectronique ou mcanique, y compris la photo-copie et les microfilms, sans laccord crit de lditeur.No part of this publication may be reproduced or utilized inany form or by any mean
18、s, electronic or mechanical,including photocopying and microfilm, without permission inwriting from the publisher.International Electrotechnical Commission 3, rue de Varemb Geneva, SwitzerlandTelefax: +41 22 919 0300 e-mail: inmailiec.ch IEC web site http: /www.iec.chCODE PRIXPRICE CODESCopyright In
19、ternational Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,- 2 60601-2-7 IEC:1998 (E)CONTENTSPageFOREWORD 4SECTION 1: GENERALClause1 Scope and object . 51.1 Scope . 51.2 Object. 51.3 Particular Standar
20、ds . 62 Terminology and definitions 72.101 Qualifying conditions for defined terms 83 General requirements 95 Classification . 96 Identification, marking and documents 96.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts 96.7 Indicator lights and push-buttons. 106.8 ACCOMPANYING DOCUMENTS . 1
21、1SECTION 2: ENVIRONMENTAL CONDITIONS10 Environmental conditions . 13SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS15 Limitation of voltage and/or energy. 1516 ENCLOSURES and PROTECTIVE COVERS 1519 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 1519.3 Allowable values. 1520 Dielec
22、tric strength 1620.3 Values of test voltages 1620.4 Tests 17SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDSSECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OREXCESSIVE RADIATION29 X-RADIATION. 1829.1 X-RADIATION generated by diagnostic X-RAY GENERATORS containingHIGH-VOLTAGE GENERATORS . 1836 El
23、ectromagnetic compatibility. 22Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-60601-2-7 IEC:1998 (E) 3 SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OFFLAMMABLE ANAESTHETIC
24、 MIXTURESSECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES ANDOTHER SAFETY HAZARDS42 Excessive temperatures. 22SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTIONAGAINST HAZARDOUS OUTPUT50 Accuracy of operating data. 2350.1 General 2350.101 Indication of electric and RADIATION output 2350.102 Re
25、producibility, linearity and constancy 2450.103 Accuracy of LOADING FACTORS. 2850.104 Test conditions 2850.105 Conditions for measuring AIR KERMA . 3051 Protection against hazardous output 32SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;ENVIRONMENTAL TESTSSECTION 10: CONSTRUCTIONAL REQUIREMENTS
26、56 Components and general assembly 3256.7 Batteries 3257 MAINS PARTS, components and layout. 3357.10 CREEPAGE DISTANCES and AIR CLEARANCES 33Tables101 Reference values for the APPARENT RESISTANCE OF SUPPLY MAINS 13102 Duration of dielectric strength test 17103 LOADINGS for testing AUTOMATIC EXPOSURE
27、 CONTROLS 27104 ATTENUATION for the measurement of AIR KERMA . 31105 Tests for verifying reproducibility and linearity. 32CC.1 Recommended LOADING FACTORS for the testing of accuracy . 41CC.2 Test settings for measurement of AIR KERMA . 42Figures101 Recommended arrangement for measuring AIR KERMA 34
28、102 Recommended arrangement for film density testing AUTOMATIC CONTROL SYSTEMSprovided with a TRANSMISSION CHAMBER 35AnnexesAA Terminology Index of defined terms . 36BB Values of the series R10 and R20, ISO 497. 39CC Choosing LOADING FACTORS for tests . 40Copyright International Electrotechnical Com
29、mission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,- 4 60601-2-7 IEC:1998 (E)INTERNATIONAL ELECTROTECHNICAL COMMISSION_MEDICAL ELECTRICAL EQUIPMENT Part 2-7: Particular requirements for the safety ofhigh-voltage generators of
30、 diagnostic X-ray generatorsFOREWORD1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprisingall national electrotechnical committees (IEC National Committees). The object of the IEC is to promoteinternational co-operation on all questions conc
31、erning standardization in the electrical and electronic fields. Tothis end and in addition to other activities, the IEC publishes International Standards. Their preparation isentrusted to technical committees; any IEC National Committee interested in the subject dealt with mayparticipate in this pre
32、paratory work. International, governmental and non-governmental organizations liaisingwith the IEC also participate in this preparation. The IEC collaborates closely with the International Organization forStandardization (ISO) in accordance with conditions determined by agreement between the two org
33、anizations.2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, aninternational consensus of opinion on the relevant subjects since each technical committee has representationfrom all interested National Committees.3) The documents produced have the f
34、orm of recommendations for international use and are published in the formof 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 InternationalStandards t
35、ransparently to the maximum extent possible in their national and regional standards. Anydivergence between the IEC Standard and the corresponding national or regional standard shall be clearlyindicated in the latter.5) The IEC provides no marking procedure to indicate its approval and cannot be ren
36、dered responsible for anyequipment declared to be in conformity with one of its standards.6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subjectof patent rights. The IEC shall not be held responsible for identifying any or all such patent
37、 rights.International Standard IEC 60601-2-7 has been prepared by subcommittee 62B: Diagnosticimaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.This second edition cancels and replaces the first edition published in 1987, and constitutes atechnical revision.
38、The text of this standard is based on the following documents:FDIS Report on voting62B/329/FDIS 62B/334/RVDFull information on the voting for the approval of this standard can be found in the report onvoting indicated in the above table.Annexes AA and BB form an integral part of this standard.Annex
39、CC is for information only.In this standard, the following print types are used: requirements, compliance with which can be tested and definitions: roman type; explanations, advice, notes, general statements and exceptions: smaller type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF
40、 THE GENERAL STANDARD OR IN IEC 60788: SMALL CAPITALS.A bilingual version of this standard may be issued at a later date.Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,-60601-2-
41、7 IEC:1998 (E) 5 MEDICAL ELECTRICAL EQUIPMENT Part 2-7: Particular requirements for the safety ofhigh-voltage generators of diagnostic X-ray generatorsSECTION 1: GENERALThe clauses and subclauses of this section of the General Standard apply except as follows:1 Scope and objectThis clause of the Gen
42、eral Standard applies except as follows:1.1 ScopeReplacement:This Particular Standard applies to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAYGENERATORS and to their subassemblies including the following: HIGH-VOLTAGE GENERATORS that are integrated with an X-RAY TUBE ASSEMBLY; HIGH-VOLTAGE GEN
43、ERATORS of radiotherapy treatment simulators.Where appropriate, requirements for X-RAY GENERATORS are given but only where theseconcern the functioning of the associated HIGH-VOLTAGE GENERATOR.This standard excludes CAPACITOR DISCHARGE HIGH-VOLTAGE GENERATORS (these are covered by IEC 60601-2-15), H
44、IGH-VOLTAGE GENERATORS for mammography, HIGH-VOLTAGE GENERATORS for RECONSTRUCTIVE TOMOGRAPHY.1.2 ObjectReplacement:The object of this standard is to establish particular requirements to ensure safety and tospecify methods for demonstrating compliance with those requirements.NOTE 1 Requirements for
45、reproducibility, linearity, constancy and accuracy are given because of theirrelationship to the quality and quantity of the IONIZING RADIATION produced, and are confined to those considerednecessary for safety.NOTE 2 Both the levels for compliance and the tests prescribed to determine compliance re
46、flect the fact that thesafety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance. The combinationsof LOADING FACTORS specified for the tests are, therefore, limited in number but chosen from experience as beingappropriate in most cases. It is considered importa
47、nt to standardize the choice of combinations of LOADING FACTORSso that comparison can be made between tests performed in different places on different occasions. However,combinations other than those specified could be of equal technical validity.NOTE 3 The safety philosophy on which this standard i
48、s based is described in the introduction to the GeneralStandard and in IEC 60513.Copyright International Electrotechnical Commission Provided by IHS under license with IECNot for ResaleNo reproduction or networking permitted without license from IHS-,- 6 60601-2-7 IEC:1998 (E)NOTE 4 Concerning RADIOLOGICAL PROTECTION it has been assumed in the preparation of this standardthat MANUFACTURERS and USERS do accept the general principles of the ICRP as stated in ICRP 60, 1990,paragraph 112,1)namely:a) “No practice involving e
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