EN 60601-2-11-2015 en Medical electrical equipment - Part 2-11 Particular requirements for the basic safety and essential performance of gamma beam therapy equipment.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipmentBS EN 60601-2-11:2015National forewordThis British Standard is the UK implementation of EN 60601-2-11:2015. It isidentical to IEC 6060

2、1-2-11:2013. It supersedes BS EN 60601-2-11:1998,which will be withdrawn on 14 April 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee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 dos

3、imetry.A list of organizations represented on this committee can 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 S

4、tandards Limited 2015ISBN 978 0 580 63288 4ICS 11.040.50Compliance 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 publication

5、Date Text affectedBRITISH STANDARDBS EN 60601-2-11:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-11 May 2015 ICS 11.040.60 Supersedes EN 60601-2-11:1997 English Version Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance

6、 of gamma beam therapy equipment (IEC 60601-2-11:2013) Appareils lectromdicaux - Part 2-11: Exigences particulires pour la scurit de base et les performances essentielles des appareils de gammathrapie (IEC 60601-2-11:2013) Medizinische elektrische Gerte - Teil 2-11: Besondere Festlegungen fr die Str

7、ahlensicherheit von Gamma-Bestrahlungseinrichtungen (IEC 60601-2-11:2013) This European Standard was approved by CENELEC on 2015-04-14. 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 natio

8、nal standard 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

9、version 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, Bulga

10、ria, Croatia, 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, Switzerl

11、and, Turkey 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

12、 form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-11:2015 E BS EN 60601-2-11:2015EN 60601-2-11:2015 2 Foreword The text of document 62C/552/FDIS, future edition 3 of IEC 60601-2-11, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosime

13、try“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-11:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national

14、 standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-11:1997. Attention is drawn to the possibility that some of the elements of this document may be the subjec

15、t 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 requirements of EU Directive

16、(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 Standard IEC 60601-2-11:2013 was approved by CENELEC as a European Standard without any modification. BS EN 60601-2-11:2015EN

17、60601-2-11:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the

18、 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 modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the l

19、atest versions of the European Standards 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 Replacement in Annex ZA of EN 60601-1:2006: IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General r

20、equirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 2008 - - + corrigendum Mar. 2010 Addition to Annex ZA of EN 60601-1:2006: IEC 61217 - Radiotherapy equipment - Coordinates, movements and scales EN 61217 - IE

21、C/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 60601-2-11:2015EN 60601-2-11:2015 4 Annex 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 t

22、he 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 this standard provides one means of conformity with the specified essential requirem

23、ents 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 60601-2-11:2015 2 60601-2-11 IEC:2013 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 Normative re

24、ferences 7 201.2Terms and definitions 8 201.3General requirements 11 201.4General requirements for testing of ME EQUIPMENT . 12 201.5Classification of ME EQUIPMENT and ME SYSTEMS 12 201.6ME EQUIPMENT identification, marking and documents 13 201.7Protection against electrical HAZARDS from ME EQUIPMEN

25、T 18 201.8Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 18 201.9Protection against unwanted and excessive radiation HAZARDS 20 201.10 Protection against excessive temperatures and other HAZARDS 38 201.11Accuracy of controls and instruments and protection against hazardous 201.

26、12outputs 39 HAZARDOUS SITUATIONS and fault conditions . 39 201.13201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTESM (PEMS) . 39 Construction of ME EQUIPMENT . 40 201.15ME SYSTEMS 40 201.16Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 40 201.17Annexes . 45 Annex B (informative) Sequence

27、 of testing 45 Index of defined terms used in this particular standard 46 Figure 201.101 Leakage radiation 40 Figure 201.102 Points for the measurement of average leakage 42 Figure 201.103 Test plane orthogonal to the RADIATION BEAM AXIS at the NORMAL TREATMENT DISTANCE . 43 Figure 201.104 Location

28、of test points for SITE TEST of item 201.10.2.5.2.2 43 Figure 201.105 Matrix measurement points for beam off and beam on conditions to be specified at the floor level, ISOCENTER level and 1 m above the ISOCENTER level (see requirement 201.10.2.4.2) . 44 Table 201.101 Colours of TREATMENT CONTROL PAN

29、EL . 14 Table 201.102 Subclauses in this particular standard requiring the provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and the technical description 14 Table 201.103 Subclauses where data is described that is required in the technical description to support Clause 20

30、1.10 site test compliance 17 BS EN 60601-2-11:201560601-2-11 IEC:2013 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment FOREWORD 1) The International Electrotech

31、nical 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 the electrical and electronic fields. To thi

32、s end and in addition to other activities, IEC publishes International Standards, Technical Specifications, 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

33、Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) i

34、n 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, an international consensus of opinion on the relevant subjects since each technical committee has representation from

35、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 all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held

36、 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 apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any div

37、ergence 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 conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC

38、 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 publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual ex

39、perts 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 indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC

40、 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 correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC

41、 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 60601-2-11 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical commi

42、ttee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its c

43、ollateral standards. The text of this standard is based on the following documents: FDIS Report on voting 62C/552/FDIS 62C/558/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. BS EN 60601-2-11:2015 4 60601-2-11 IE

44、C:2013 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 appearing outside of tables, such as notes, examples and

45、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 “clause” means one of the seventeen numbered divisions

46、 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 within this standard are preceded by the term “Clause”

47、 followed by the clause number. References to subclauses within this collateral 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 conditions is true. The verbal forms used in this standard conform to usag

48、e 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 with a requirement or a test is recommended but i

49、s 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 remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific pu