IEC 60601-2-44-2009 Medical electrical equipment - Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipment for compu.pdf

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1、 IEC 60601-2-44Edition 3.0 2009-02INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography Appareils lectromdicaux Partie 2-44: Exigences particulires pour la s

2、curit de base et les performances essentielles des quipements rayonnement X de tomodensitomtrie IEC60601-2-44:2009 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilize

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16、ez 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 60601-2-44Edition 3.0 2009-02INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipm

17、ent Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography Appareils lectromdicaux Partie 2-44: Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement X de tomodensitomtrie INTERN

18、ATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XICS 11.040.50 PRICE CODECODE PRIXISBN 2-8318-1032-8 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-2-44 IEC:2009 CONTENTS FOREW

19、ORD.3 201.1 Scope, object and related standards5 201.2 Normative references 7 201.3 Terms and definitions 7 201.4 General requirements12 201.5 General requirements for testing of ME EQUIPMENT.13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 13 201.7 ME EQUIPMENT identification, marking and doc

20、uments14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT16 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS 19 201.10 Protection against unwanted and excessive RADIATION HAZARDS 22 201.11 Protection against excessive temperatures and other HAZARDS22 201.12 Acc

21、uracy of controls and instruments and protection against hazardous outputs22 201.13 Hazardous situations and fault conditions23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .23 201.15 Construction of ME EQUIPMENT .23 201.16 ME SYSTEMS.23 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT

22、and ME SYSTEMS.24 203 General requirements for RADIATION protection in diagnostic X-ray equipment .24 Annexes .38 Annex A (informative) Choosing LOADING FACTORS for tests39 Annex B (informative) Estimating CTDIvolfor scan projection RADIOGRAPHY (SPR) 40 Bibliography41 Index of defined terms used in

23、this particular standard42 Figure 201.101 Coordinate system.9 Figure 203.101 Zone of extra-focal RADIATION 29 Figure 203.102 Minimum dimensions for STRAY RADIATION measurement32 Table 203.101 Test pattern for CTDIfree air.36 60601-2-44 IEC:2009 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL E

24、LECTRICAL EQUIPMENT Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical co

25、mmittees (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, Techni

26、cal Reports, 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, government

27、al and 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 agr

28、eements 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

29、 and are 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 promo

30、te international 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 indica

31、ted in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach t

32、o 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 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) an

33、d 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. Use of the referenced publications is indispensable for the correct application of this publication. 9

34、) 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 patent rights. International standard IEC 60601-2-44 has been prepared by subcommittee 62B: Diagnostic imag

35、ing equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to RADIATION protection and control. The te

36、xt of this particular standard is based on the following documents: FDIS Report on voting 62B/727/FDIS 62B/734/RVDFull information on the 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 accord

37、ance with the ISO/IEC Directives, Part 2. 4 60601-2-44 IEC:2009 In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type.

38、 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 CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of content

39、s, 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 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 numb

40、er. 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 statement 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 th

41、e 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 for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for complian

42、ce with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. 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. The committee has decided that the conten

43、ts of this particular standard will remain unchanged until the maintenance result 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 revised edition, or amended.

44、 NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip them

45、selves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication. 60601-2-44 IEC:2009 5 MEDICAL ELECTRICAL EQUIPMENT Part 2-44: Particular requirem

46、ents for the basic safety and essential performance of X-ray equipment for computed tomography 201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERF

47、ORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies

48、both to ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 1 See also 4.2 of the general standard. The scope of this document is limited to CT SCANNERS intended to be used for both head and body characterised by an ENCLOSURE of the X-ray source(s) and imaging detector(s) in a common protective cover

49、in the shape of a toroid. It includes safety requirements for the X-RAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY. NOTE 2 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition