IEC 60601-2-43-2010 Medical electrical equipment - Part 2-43 Particular requirements for basic safety and essential performance of X-ray equipment for intervent.pdf

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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

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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

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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