1、 IEC 60601-2-64 Edition 1.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment Appareils lectromdicaux Partie 2-64: Exigences particulires po
2、ur la scurit de base et les performances essentielles des appareils lectromdicaux par faisceau dions lgers IEC 60601-2-64:2014-09(en-fr) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publ
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20、2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment Appareils lectromdicaux Partie 2-64: Exigences particulires pour la scurit de base et les
21、performances essentielles des appareils lectromdicaux par faisceau dions lgers INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XA ICS 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-8322-1825-9 Registered trademark of the International Electrotechnical Commission Marqu
22、e dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colour inside 2 IEC 60601-2-64:2014 IEC 2014 CONTENTS FOREWO
23、RD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references . 8 201.3 Terms and definitions . 9 201.4 General requirements . 14 201.5 General requirements for testing of ME EQUIPMENT 14 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 15 201.7 ME EQUIPMENT ide
24、ntification, marking and documents . 15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19 201.10 Protection against unwanted and excessive radiation HAZARDS . 24 201.11 Protection against excessive tempe
25、ratures and other HAZARDS . 45 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 45 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 46 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 46 201.15 Construction of ME EQUIPMENT . 46 201.16 M
26、E SYSTEMS 46 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS 46 201.101 ELECTRONIC IMAGING DEVICES (EID) . 47 206 Usability . 47 Annexes . 50 Annex B (informative) Sequence of testing . 50 Annex I (informative) ME SYSTEMS aspects 50 Bibliography 51 Index of defined terms used in
27、this particular standard 52 Figure 201.101 PATIENT SUPPORT movements . 48 Figure 201.102 Diagram illustrating example RADIATION HEAD components and possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 49 Figure 201.103 Diagram illustrating distance along PATIENT plane to measure NON-PR
28、IMARY RADIATION ABSORBED DOSE 49 Table 201.101 Data required in the technical description to support Clause 201.10 SITE TEST compliance 17 IEC 60601-2-64:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Particular requirements for the basic safety and essentia
29、l performance of LIGHT ION BEAM ME EQUIPMENT FOREWORD 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 al
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39、cation. 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 patent rights. International Standard IEC 60601-2-64 has been prepared by subcommittee 62C: Equipm
40、ent for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. The text of this standard is based on the following documents: FDIS Report on voting 62C/594/FDIS 62C/600/RVD Full information on the voting for the approval of th
41、is standard can be found in the report on voting indicated in the above table. 4 IEC 60601-2-64:2014 IEC 2014 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 spec
42、ifications: 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 CAPITALS. In refer
43、ring to the structure of this standard, the term “clause” means one of the 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 subclaus
44、es 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 statement is true if any
45、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 for compliance with th
46、is 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. A list of all parts of the IEC 60601 series, published under t
47、he general title Medical electrical equipment, can be found on the IEC website. 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.
48、At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The colour inside logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users sh
49、ould therefore print this document using a colour printer. IEC 60601-2-64:2014 IEC 2014 5 INTRODUCTION The use of LIGHT ION BEAM ME EQUIPMENT for RADIOTHERAPY purposes may expose PATIENTS to danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The ME EQUIPMENT may also cause danger to per
