1、Medical electrical equipmentPart 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeVBS EN 60601-2-1:2015Incorporating corrigendum October 2016(IEC 60601-2-1:2009+A1:2014)BSI Standards PublicationBS EN 60601-2-1:2015 BRITIS
2、H STANDARDNational forewordThis British Standard is the UK implementation of EN 60601-2-1:2015. It is identical to IEC 60601-2-1:2009 JODPSQPSBUJOHBNFOENFOU. It supersedes BS EN 60601-2-1:1998 which will be withdrawn on 15 September 2018.The start and finish of text introduced or altered by amendmen
3、t is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by g1g2.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practic
4、e, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are res
5、ponsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 95851 9ICS 11.040.60Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Stan
6、dards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate Text affected31 October 2016 IEC amendment 1:2014 changes incorporatedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-1 October 2015 ICS 11.040.60 Supersedes EN 60601-2-1:1998Engli
7、sh Version Medical 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 (IEC 60601-2-1:2009 + A1:2014) Appareils lectromdicaux - Partie 2-1: Exigences particulires de scurit de base et de perform
8、ances essentielles pour les acclrateurs dlectrons dans la gamme de 1 MeV 50 MeV (IEC 60601-2-1:2009 + A1:2014) Medizinische elektrische Gerte - Teil 2-1: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Elektronenbeschleunigern im Bereich von 1 MeV bis 50
9、 MeV (IEC 60601-2-1:2009 + A1:2014) This European Standard was approved by CENELEC on 2015-09-15. 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 standard without any alteration. U
10、p-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 version in any other language made by
11、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, Croatia, Cyprus, the Czech Republ
12、ic, 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, Turkey and the United Kingdom. Eu
13、ropean 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 and by any means reserved worldw
14、ide for CENELEC Members. Ref. No. EN 60601-2-1:2015 EBS EN 60601-2-1:2015European foreword The text of document 62C/474/FDIS, future edition 3 of IEC 60601-2-1, and the text of document 62C/532/CDV, future IEC 60601-2-1/A1, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiati
15、on dosimetry“, of IEC/TC 62 “Electrical equipment in medical practice“ were submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-1:2015. The following dates are fixed: g120 latest date by which the document has to be implemented at national level by publication of an iden
16、tical national standard or by endorsement (dop) 2016-06-15 g120 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-09-15 This document supersedes EN 60601-2-1:1998. Attention is drawn to the possibility that some of the elements of this document
17、 may be the subject of patent rights. CENELEC and/or CEN shall not be held 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 requiremen
18、ts of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standards IEC 60601-2-1:2009 and IEC 60601-2-1:2009/A1:2014 were approved by CENELEC as a European Standard
19、without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60976:2007 NOTE Harmonized as EN 60976:2007 (not modified). IEC 62366 NOTE Harmonized as EN 62366. 2 BS EN 60601-2-1:2015EN 60601-2-1:2015Annex ZA (normative) No
20、rmative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated refer
21、ences, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards
22、listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Addition to Annex ZA of EN 60601-1:2006: IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 61217 1996 Radiotherapy equipm
23、ent - Coordinates, movements and scales EN 61217 1996 3 BS EN 60601-2-1:2015EN 60601-2-1:2015Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Ass
24、ociation, 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 this standard provides one means of conformity with the specified essential requirements of the Directive conc
25、erned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. 4 BS EN 60601-2-1:2015EN 60601-2-1:2015 2 60601-2-1 IEC:2009 CONTENTS FOREWORD.4g3INTRODUCTION.7g3201.1 Scope, object and related standards .8g3201.2 Normative referen
26、ces10g3201.3 Terms and definitions11g3201.4 General requirements .14g3201.5 General requirements for testing ME EQUIPMENT 14g3201.6 Classification of ME EQUIPMENT and ME SYSTEMS15g3201.7 ME EQUIPMENT identification, marking and documents .15g3201.8 Protection against electrical HAZARDS from ME EQUIP
27、MENT .21g3201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .22g3201.10 Protection against unwanted and excessive radiation HAZARDS .25g3201.11 Protection against excessive temperatures and other HAZARDS .47g3201.12 Accuracy of controls and instruments and protection against
28、 hazardous outputs .47g3201.13 HAZARDOUS SITUATIONS and fault conditions 47g3201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47g3201.15 Construction of ME EQUIPMENT.48g3201.16 ME SYSTEMS 48g3201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS 48g3206 Usability50g3Annexes .59g3A
29、nnex B (informative) Sequence of testing 59g3Annex I (informative) ME SYSTEMS aspects.59g3Bibliography60g3Index of defined terms 61g3Figure 201.101 Limits of STRAY X-RADIATION during ELECTRON IRRADIATION (201.10.1.2.102.1) 51g3Figure 201.102 Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (201.
30、10.1.2.102.2) 52g3Figure 201.103 Elevation view Application of LEAKAGE RADIATION requirements (201.10.1.2.103 and 201.10.1.2.104) 53g3Figure 201.104 24 measurement points for averaging LEAKAGE RADIATION during X-RADIATION (201.10.1.2.103.2.1) .54g3Figure 201.105 Limits of LEAKAGE RADIATION through t
31、he BEAM LIMITING DEVICES during ELECTRON IRRADIATION (201.10.1.2.103.2.2).55g3Figure 201.106 Measurement points for averaging LEAKAGE RADIATION during ELECTRON IRRADIATION (201.10.1.2.103.2.2).56g3Figure 201.107 24 measurement points for averaging LEAKAGE RADIATION outside area M (201.10.1.2.103.3).
32、57g3Figure 201.108 ME EQUIPMENT movements and scales .58g3Table 201.101 Colours of indicator lights and their meaning for ME EQUIPMENT.16g3BS EN 60601-2-1:2015IEC 60601-2-1:2009+A1:2014 5 710111314171718182425285050505051515253626262636454555657585960611960601-2-1 IEC:2009 3 Table 201.102 Data requi
33、red in the technical description to support Clause 201.10 SITE TEST compliance 18g3Table 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 .20g3Table 201.104 Limits of
34、 STRAY X-RADIATION during ELECTRON IRRADIATION (see Figure 201.101) 39g3Table 201.105 Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see Figure 201.102) 39g3BS EN 60601-2-1:2015IEC 60601-2-1:2009+A1:2014 6 21234243 4 60601-2-1 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECT
35、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 FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechni
36、cal committees (IEC National Committees). The object of IEC is to promote 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,
37、Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter 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, gove
38、rnmental and non-governmental organizations liaising with the IEC also participate 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
39、or agreements of IEC on technical matters express, as nearly as possible, 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 internation
40、al use and are accepted by IEC National Committees in that sense. While all 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
41、 promote international uniformity, IEC National Committees undertake to apply 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
42、indicated in the latter. 5) IEC itself does not provide any attestation of 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 bodie
43、s. 6) All users should ensure that they have the latest edition of this publication. 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
44、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, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this
45、publication. Use of the referenced publications is indispensable for the correct 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 a
46、ll such patent rights. International Standard IEC 60601-2-1 has been prepared by IEC subcommittee 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 edi
47、tion published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. BS EN 60601-2-1:2015IEC 60601-2-1:2009+A1:2014 7 60601-2-1 IEC:2009 5 This third edition addresses the following issues not covered in previous editions: alignment with the new relevant collateral standards; new
48、technologies in radiotherapy, including: stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT); intensity modulated radiotherapy (IMRT); electronic imaging devices (e.g. EPID); moving beam radiotherapy (dynamic therapy). The text of this particular standard is based on the following do
49、cuments: FDIS Report on voting 62C/474/FDIS 62C/480/RVD Full information on the voting for the approval of this particular standard can 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 materia
