IEC 60601-2-1-2009 Medical electrical equipment - Part 2-1 Particular requirements for the basic safety and essential performance of electron accelerators in th.pdf

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1、 IEC 60601-2-1Edition 3.0 2009-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV Appareils lectromdicaux Partie 2-1: Exigences particulires d

2、e scurit de base et de performances essentielles pour les acclrateurs dlectrons dans la gamme de 1 MeV 50 MeV IEC60601-2-1:2009 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduc

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17、rical equipment Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV Appareils lectromdicaux Partie 2-1: Exigences particulires de scurit de base et de performances essentielles pour les acclrateurs dlectrons dans la g

18、amme de 1 MeV 50 MeV INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XBICS 11.040.60 PRICE CODECODE PRIXISBN 2-8318-1062-1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-

19、2-1 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.7 201.1 Scope, object and related standards .8 201.2 Normative references10 201.3 Terms and definitions11 201.4 General requirements .14 201.5 General requirements for testing ME EQUIPMENT 14 201.6 Classification of ME EQUIPMENT and ME SYSTEMS15 201.7 ME

20、 EQUIPMENT identification, marking and documents .15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .21 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .22 201.10 Protection against unwanted and excessive radiation HAZARDS .25 201.11 Protection against exces

21、sive temperatures and other HAZARDS .47 201.12 Accuracy of controls and instruments and protection against hazardous outputs .47 201.13 HAZARDOUS SITUATIONS and fault conditions 47 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47 201.15 Construction of ME EQUIPMENT.48 201.16 ME SYSTEMS 48 20

22、1.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS 48 206 Usability50 Annexes .59 Annex B (informative) Sequence of testing 59 Annex I (informative) ME SYSTEMS aspects.59 Bibliography60 Index of defined terms 61 Figure 201.101 Limits of STRAY X-RADIATION during ELECTRON IRRADIATION (2

23、01.10.1.2.102.1) 51 Figure 201.102 Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (201.10.1.2.102.2) 52 Figure 201.103 Elevation view Application of LEAKAGE RADIATION requirements (201.10.1.2.103 and 201.10.1.2.104) 53 Figure 201.104 24 measurement points for averaging LEAKAGE RADIATION during

24、 X-RADIATION (201.10.1.2.103.2.1) .54 Figure 201.105 Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during ELECTRON IRRADIATION (201.10.1.2.103.2.2).55 Figure 201.106 Measurement points for averaging LEAKAGE RADIATION during ELECTRON IRRADIATION (201.10.1.2.103.2.2).56 Figure 201.107

25、24 measurement points for averaging LEAKAGE RADIATION outside area M (201.10.1.2.103.3).57 Figure 201.108 ME EQUIPMENT movements and scales .58 Table 201.101 Colours of indicator lights and their meaning for ME EQUIPMENT.16 60601-2-1 IEC:2009 3 Table 201.102 Data required in the technical descriptio

26、n to support Clause 201.10 SITE TEST compliance 18 Table 201.103 Clauses and subclauses in this particular standard that require the provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and the technical description .20 Table 201.104 Limits of STRAY X-RADIATION during ELECTRO

27、N IRRADIATION (see Figure 201.101) 39 Table 201.105 Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see Figure 201.102) 39 4 60601-2-1 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-1: Particular requirements for the basic safety and essential performa

28、nce of electron accelerators in the range 1 MeV to 50 MeV 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-op

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38、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 patent rights. International Standard IEC 60601-2-1 has been prepared by IEC subcommi

39、ttee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. 60601

40、-2-1 IEC:2009 5 This third edition addresses the following issues not covered in previous editions: alignment with the new relevant collateral standards; new technologies in radiotherapy, including: stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT); intensity modulated radiotherapy

41、 (IMRT); electronic imaging devices (e.g. EPID); moving beam radiotherapy (dynamic therapy). The text of this particular standard is based on the following documents: FDIS Report on voting 62C/474/FDIS 62C/480/RVD Full information on the voting for the approval of this particular standard can be fou

42、nd 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 appeari

43、ng 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 term “cla

44、use” 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 clauses with

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46、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 compliance

47、 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 the general title: Medical electrical equipm

48、ent can be found on the IEC website. 6 60601-2-1 IEC:2009 The committee has decided that the contents of this publication 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,

49、 the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 60601-2-1 IEC:2009 7 INTRODUCTION The use of ELECTRON ACCELERATORS 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