IEC 60601-2-68-2014 Medical electrical equipment - Part 2-68 Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipme.pdf

1、 IEC 60601-2-68 Edition 1.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy

2、 equipment and radionuclide beam therapy equipment Appareils lectromdicaux Partie 2-68: Exigences particulires pour la scurit de base et les performances essentielles des appareils de radiothrapie rayonnement X assiste par imagerie mdicale, destins tre utiliss avec les acclrateurs dlectrons, les app

3、areils de thrapie par faisceau dions lgers et les appareils de thrapie par faisceau de radionuclides IEC 60601-2-68:2014-09(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be repro

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21、L STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipme

22、nt Appareils lectromdicaux Partie 2-68: Exigences particulires pour la scurit de base et les performances essentielles des appareils de radiothrapie rayonnement X assiste par imagerie mdicale, destins tre utiliss avec les acclrateurs dlectrons, les appareils de thrapie par faisceau dions lgers et le

23、s appareils de thrapie par faisceau de radionuclides INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-8322-1839-6 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission E

24、lectrotechnique 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. 2 IEC 60601-2-68:2014 IEC 2014 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, obj

25、ect and related standards . 7 201.2 Normative references 9 201.3 Terms and definitions 10 201.4 General requirements . 18 201.5 General requirements for testing ME EQUIPMENT 19 201.6 Classification of me equipment and me systems . 19 201.7 ME EQUIPMENT identification, marking and documents 19 201.8

26、Protection against electrical HAZARDS from ME EQUIPMENT . 25 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 28 201.10 Protection against unwanted and excessive radiation HAZARDS . 32 201.11 Protection against excessive temperatures and other HAZARDS . 34 201.12 Accuracy

27、 of controls and instruments and protection against hazardous outputs . 34 201.13 Hazardous situations and fault conditions for me equipment . 34 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 35 201.15 Construction of me equipment. 35 201.16 ME SYSTEMS 35 201.17 Electromagnetic compatibili

28、ty of ME EQUIPMENT and ME SYSTEMS . 35 201.101 Reference data for X-IGRT . 36 201.102 X-IGRT IMAGING 40 201.103 IGRT analysis and correction . 47 203 RADIATION protection in diagnostic X-RAY EQUIPMENT . 51 206 Usability 52 Annex B (informative) Sequence of testing 54 Annex I (informative) ME SYSTEMS

29、 aspects . 54 Annex AA (informative) Particular guidance and rationale 55 Annex BB (informative) Measuring CTDI free air. 57 Bibliography 58 Index of defined terms used in this standard . 59 Figure 201.101 PATIENT SUPPORT movements 53 Table 201.101 Data required in the technical description . 22 Tab

30、le 201.102 Clauses and subclauses in this particular standard that require the provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and the technical description . 23 Table 201.103 Example test pattern for CTDI free air for kV . 45 IEC 60601-2-68:2014 IEC 2014 3 INTERNATIONAL

31、 ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipmen

32、t 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 all questions concerning standardization in t

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42、bility 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 60601-2-68 has been prepared by IEC subcommittee 62C Equipment for radiotherapy, nuclear medicine

43、and radiation dosimetry of IEC technical committee 62: Electrical equipment in medical practice. The text of this particular standard is based on the following documents: FDIS Report on voting 62C/595/FDIS 62C/602/RVD Full information on the voting for the approval of this standard can be found in t

44、he report on voting indicated in the above table. 4 IEC 60601-2-68:2014 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 specifications: italic type. Info

45、rmative 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 referring to the structure of this

46、 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 7.2.1 are all subclauses of Clause 7). Re

47、ferences 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 combination of the

48、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 this standard; “shoul

49、d” 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 of 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