1、 IEC 60601-2-43Edition 2.0 2010-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures Appareils lectromdicaux Partie 2-43: Exigences particulires pou
2、r la scurit de base et les performances essentielles des appareils rayonnement X lors dinterventions IEC60601-2-43:2010 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2010 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or ut
3、ilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additi
4、onal rights to this publication, please contact the address below or your local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par
5、aucun procd, lectronique ou mcanique, y compris la photocopie et les microfilms, sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez
6、les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that p
7、repares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have
8、 been published. Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: www.iec.ch/onl
9、ine_news/justpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 00
10、0 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance,
11、 please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des normes internationales pour tout ce qui a tr
12、ait llectricit, llectronique et aux technologies apparentes. A propos des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue des publications
13、de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications retires ou remplaces. Just Published CEI: w
14、ww.iec.ch/online_news/justpub Restez inform sur les nouvelles publications de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniqu
15、es et lectriques. Il contient plus de 20 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm Si vous
16、 dsirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60601-2-43Edition 2.0 2010-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical e
17、quipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures Appareils lectromdicaux Partie 2-43: Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X lors dinterventi
18、ons INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XAICS 11.40.50; 37.040.25 PRICE CODECODE PRIXISBN 2-8318-1086-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-2-43 IE
19、C:2010 CONTENTS FOREWORD.3 INTRODUCTION.6 201.1 Scope, object and related standards .7 201.2 Normative references 9 201.3 Terms and definitions9 201.4 General requirements10 201.5 General requirements for testing of ME EQUIPMENT.11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUI
20、PMENT identification, marking and documents12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT16 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS16 201.10 Protection against unwanted and excessive radiation HAZARDS17 201.11 Protection against excessive temperat
21、ures and other HAZARDS17 201.12 Accuracy of controls and instruments and protection against hazardous outputs19 201.13 HAZARDOUS SITUATIONS and fault conditions.22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .22 201.15 Construction of ME EQUIPMENT .22 201.16 ME SYSTEMS 23 201.17 Electromag
22、netic compatibility of ME EQUIPMENT and ME SYSTEMS .23 202 Electromagnetic compatibility Requirements and tests .23 203 Radiation protection in diagnostic X-ray equipment .24 Annexes .34 Annex AA (informative) Particular guidance and rationale35 Annex BB (normative) Distribution maps of STRAY RADIAT
23、ION43 Annex CC (informative) Mapping between this Edition 2 of IEC 60601-2-43 and Edition 1 .47 Bibliography49 Index of defined terms used in this particular standard51 Figure BB.1 Example of isokerma map at 100 cm height in lateral configuration 45 Figure BB.2 Example of isokerma map at 100 cm heig
24、ht in vertical configuration.46 Table 201.101 Additional list of potential ESSENTIAL PERFORMANCE to be considered by MANUFACTURER in the RISK MANAGEMENT analysis10 Table 201.102 Other subclauses requiring statements in ACCOMPANYING DOCUMENTS .15 Table AA.1 Examples of prolonged RADIOSCOPICALLY GUIDE
25、D INTERVENTIONAL PROCEDURES for which deterministic effects of IRRADIATION are possible 35 Table AA.2 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for which deterministic effects are unlikely .36 60601-2-43 IEC:2010 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQU
26、IPMENT Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committee
27、s (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Rep
28、orts, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). 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
29、non-governmental organizations liaising with the IEC also participate in this preparation. 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
30、 of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and ar
31、e accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote inte
32、rnational uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
33、the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All use
34、rs should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or oth
35、er damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication.
36、Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such paten
37、t rights. International standard IEC 60601-2-43 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a t
38、echnical revision. This particular standard has been revised to provide a complete set of safety requirements for X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a syst
39、em standard for X-RAY EQUIPMENT designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration. 4 60601-2-43 IEC:2010 The text of this standard is based on the following documents: FDIS Report on voting 62B/779/FDIS 62B/792/RVDFull information on t
40、he voting for the approval of this particular standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman typ
41、e. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITA
42、LS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and
43、7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a sta
44、tement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory
45、for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character o
46、f a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. 60601-2-43 IEC:201
47、0 5 The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a
48、revised edition, or amended. 6 60601-2-43 IEC:2010 INTRODUCTION X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may subject PATIENTS and OPERATORS to higher levels of RADIATION than those which normally prevail during diagnostic X-ray imaging procedures. One consequence for the
49、PATIENT may be the occurrence of deterministic injury when procedures involve the delivery of substantial amounts of RADIATION to localized areas. Another consequence can be an increased RISK of stochastic effects, such as cancer. These health concerns apply also to the OPERATOR. In addition, for this particular type of equipment, there is a need for availability of critical functions with m
