IEC 60601-2-45-2011 Medical electrical equipment - Part 2-45 Particular requirements for the basic safety and essential performance of mammographic X-ray equipm.pdf

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1、 IEC 60601-2-45 Edition 3.0 2011-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices Appareils lectromdicaux Partie 2-45: Ex

2、igences particulires pour la scurit de base et les performances essentielles des appareils de mammographie rayonnement X et des appareils mammographiques strotaxiques IEC60601-2-45:2011 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2011 IEC, Geneva, Switzerland All rights reserved. Unless otherw

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17、1-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices Appareils lectromdicaux Partie 2-45: Exigences particulires pour la sc

18、urit de base et les performances essentielles des appareils de mammographie rayonnement X et des appareils mammographiques strotaxiques INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XA ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-88912-347-6 Registered tradema

19、rk of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-2-45 IEC:2011 CONTENTS FOREWORD . 3 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 9 201.3 Terms and definitions 10 201.4 General requi

20、rements . 11 201.5 General requirements for testing of ME EQUIPMENT 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identification, marking and documents . 12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16 201.9 Protection against MECHANICAL HAZARDS o

21、f ME EQUIPMENT and ME SYSTEMS . 19 201.10 Protection against unwanted and excessive radiation HAZARDS . 21 201.11 Protection against excessive temperatures and other HAZARDS . 22 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 22 201.13 Hazardous situations and

22、 fault conditions . 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22 201.15 Construction of ME EQUIPMENT . 22 201.16 ME SYSTEMS 22 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23 202 Electromagnetic compatibility Requirements and tests . 23 203 Radiation protect

23、ion in diagnostic X-ray equipment . 23 Annex AA (informative) Particular guidance and rationale 46 Bibliography 48 Index of defined terms used in this particular standard 49 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 11 Table 203.101 Minimum values of TOTAL FILTRATION and factors f

24、or determining the minimum AIR KERMA RATE 38 60601-2-45 IEC:2011 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices FOREWORD

25、 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electri

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28、ation for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical c

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31、nd regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services

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33、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) and expenses arising out of the publication, u

34、se 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) Attention is drawn to the possibility that

35、 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 60601-2-45 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62

36、: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rdedition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been

37、made with respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT. 4 60601-2-45 IEC:2011 The text of this particular standard is based on the following documents: FDIS Report on voting 62B/817/FDIS 62B/821/RVD Full information on the voting for the approval of this particular standard can

38、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 type. Test specifications: italic type. Informative material a

39、ppearing 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 CAPITALS. In referring to the structure of this standard, the ter

40、m “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 7.2.1 are all subclauses of Clause 7). References to clau

41、ses 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 statement is true if any combination of the conditions is

42、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 for compliance with this standard; “should” means that

43、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 of a title or at the beginning of a paragraph or table t

44、itle 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 60601-2-45 IEC:2011 5 The committee has decided that the contents of this

45、 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 revised edition, or amended. 6 60601-2-45 IEC:2011 INTR

46、ODUCTION The third edition of this particular standard has been prepared to provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on IEC 60601-1:2005 (3rdedition) and its collaterals. This particular standard addresses the system level of MAMMOGRAPHIC X-RAY EQUIPMENT,

47、 which consists of a combination of an X-RAY GENERATOR, associated equipment and ACCESSORIES. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of M

48、AMMOGRAPHIC X-RAY EQUIPMENT. Like the previous edition of this Part 2-45, the present third edition includes requirements on HIGH-VOLTAGE GENERATORS for mammography. 60601-2-45 IEC:2011 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-45: Particular requirements for the basic safety and essential performance o

49、f mammographic X-ray equipment and mammographic stereotactic devices 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 PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT. NOT