BS EN 60601-2-64-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment《医疗电气设备 光离子束.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipmentBS EN 60601-2-64:2015National forewordThis British Standard is the UK implementation of EN 60601-2-64:2015. It isidenti

2、cal to IEC 60601-2-64:2014.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine andradiation dosimetry.A list of organizations represented on this committee ca

3、n be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 70600 4ICS 11.040.60Complia

4、nce with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-64:2015EUROPEAN

5、 STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-64 May 2015 ICS 11.040.60 English Version Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment (IEC 60601-2-64:2014) Appareils lectromdicaux

6、 - Partie 2-64: Exigences particulires pour la scurit de base et les performances essentielles des appareils lectromdicaux par faisceau dions lgers (IEC 60601-2-64:2014) Medizinische elektrische Gerte - Teil 2-64: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkm

7、ale von Leichtionen-Bestrahlungseinrichtungen (IEC 60601-2-64:2014) This European Standard was approved by CENELEC on 2014-10-08. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national st

8、andard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A versio

9、n in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, C

10、roatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, T

11、urkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form

12、and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-64:2015 E BS EN 60601-2-64:2015EN 60601-2-64:2015 2 Foreword The text of document 62C/594/FDIS, future edition 1 of IEC 60601-2-64 prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“ of

13、 IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-64:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standar

14、d or by endorsement (dop) 2015-11-29 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-05-29 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be h

15、eld responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, s

16、ee informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-64:2014 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added fo

17、r the standard indicated: IEC 60601-2-68 NOTE Harmonized as EN 60601-2-68. BS EN 60601-2-64:2015EN 60601-2-64:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively re

18、ferenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common mo

19、difications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu Publication Year Title EN/HD Year Annex ZA of EN 60601-1:2006 applies except as follows: Replacement: IEC

20、 60601-1-2 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests EN 60601-1-2 2014 Addition: IEC 60601-1 +A1 2005 2012 Medical electrical equipment - Part 1: General r

21、equirements for basic safety and essential performance EN 60601-1 + corr. March + A1 + A1/AC +A12 2006 2010 2013 2014 2014 IEC 60601-2-1 2009 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to

22、 50 MeV - - IEC 60601-2-11 2013 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment EN 60601-2-11 2015 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 61217 2011 Radiothera

23、py equipment - Coordinates, movements and scales EN 61217 2012 ISO/IEC 14165-321 2009 Information technology - Fibre Channel - Part 321: Audio-Video (FC-AV) - - BS EN 60601-2-64:2015EN 60601-2-64:2015 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard

24、 has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with

25、this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-64:2015 2 IEC 60601-2-64:2014 IEC 2014 CONT

26、ENTS FOREWORD . 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 EQ

27、UIPMENT identification, 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 exce

28、ssive temperatures 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 .

29、46 201.16 ME 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 ter

30、ms used in 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 mea

31、sure NON-PRIMARY RADIATION ABSORBED DOSE 49 Table 201.101 Data required in the technical description to support Clause 201.10 SITE TEST compliance 17 BS EN 60601-2-64:2015IEC 60601-2-64:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Particular requirements f

32、or the basic safety and essential 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

33、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, Technical Reports, Publicly Available Specifications (PAS) and Guides (her

34、eafter 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, governmental and non-governmental organizations liaising with the IEC also par

35、ticipate 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 agreements of IEC on technical matters express, as nearly as possible,

36、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 and are accepted by IEC National Committees in that sense. While al

37、l 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 promote international uniformity, IEC National Committees undertake to ap

38、ply 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 indicated in the latter. 5) IEC itself does not provide any attestation of

39、 conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this pu

40、blication. 7) No liability shall attach to 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 indirec

41、t, or for costs (including legal fees) and 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 c

42、orrect application 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 60601-2-64 has been prep

43、ared by subcommittee 62C: Equipment 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 t

44、he voting for the approval of this standard can be found in the report on voting indicated in the above table. BS EN 60601-2-64:2015 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 use

45、d: Requirements and definitions: roman type. Test specifications: 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 PAR

46、TICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring 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

47、 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 number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is us

48、ed 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 the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a req

49、uirement 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 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 equipment, can be found on the IEC website. The committee has decided that the contents of this publication will rem