BS EN 60601-2-17-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equ.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipmentBS EN 60601-2-17:2015National forewordThis British Standard is the UK implementation of EN 60601-2-17

2、:2015. It isidentical to IEC 60601-2-17:2013. It supersedes BS EN 60601-2-17:2004,which will be withdrawn on 14 April 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee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,

3、nuclear medicine andradiation dosimetry.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 In

4、stitution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 68452 4ICS 11.040.60; 19.100Compliance 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.Amend

5、ments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-17:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-17 May 2015 ICS 11.040.60 Supersedes EN 60601-2-17:2004 English Version Medical electrical equipment - Part 2-17: Particular requirements for t

6、he basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2013) Appareils lectromdicaux - Partie 2-17: Exigences particulires pour la scurit de base et les performances essentielles des appareils projecteurs de sources radioactives cha

7、rgement diffr automatique utiliss en brachythrapie (IEC 60601-2-17:2013) Medizinische elektrische Gerte - Teil 2-17: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von ferngesteuerten, automatisch betriebenen Afterloading-Gerten fr die Brachytherapie (IEC 6

8、0601-2-17:2013) 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 national standard without any alteration. Up-to-date lists and

9、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 translation under th

10、e 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 Republic, Denmark, Estonia

11、, 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. European Committee for

12、 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 worldwide for CENELEC Memb

13、ers. Ref. No. EN 60601-2-17:2015 E BS EN 60601-2-17:2015EN 60601-2-17:2015 2 Foreword The text of document 62C/575/FDIS, future edition 3 of IEC 60601-2-17, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“, of IEC/TC 62 “Electrical equipment in medical practi

14、ce“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-17:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 latest date b

15、y which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-17:2004. 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 held r

16、esponsible 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(s). For the relationship with EU Directive 93/42/EEC, see

17、 informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-17:2013 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added fo

18、r the standards indicated: IEC 60601-2-28:2010 NOTE Harmonized as EN 60601-2-28:2010 (not modified). IEC 61217:2011 NOTE Harmonized as EN 61217:2012 (not modified). BS EN 60601-2-17:2015EN 60601-2-17:2015 3 Annex ZA (normative) Normative references to international publications with their correspond

19、ing 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 references, the latest edition of the referenced document (including any am

20、endments) 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 listed in this annex is available here: www.cenelec.eu. Annex ZA of EN

21、 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Addition to Annex ZA of EN 60601-1:2006: IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 - - + corrigendum Mar. 2010 + A1 2012 + A1 2013

22、 - - + A1/AC 2014 - - + A12 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 50 MeV - - IEC 60601-2-8 2010 Medical electrical equipment - Part 2-8: Particular require

23、ments for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV EN 60601-2-8 1)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

24、 EN 60601-2-11 2015 IEC 61005 (mod) 2003 Radiation protection instrumentation - Neutron ambient dose equivalent (rate) meters EN 61005 2004 1) To be published. BS EN 60601-2-17:2015EN 60601-2-17:2015 4 Publication Year Title EN/HD Year IEC 62083 2009 Medical electrical equipment - Requirements for t

25、he safety of radiotherapy treatment planning systems EN 62083 2009 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 60601-2-17:2015EN 60601-2-17:2015 5 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepa

26、red 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 this standard p

27、rovides 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 60601-2-17:2015 2 60601-2-17 IEC:2013 CONTENTS FOREWORD . 3 INTROD

28、UCTION . 6 Scope, object and related standards . 7 201.1Normative references 9 201.2Terms and definitions 10 201.3General requirements 12 201.4General requirements for testing ME EQUIPMENT . 12 201.5Classification of ME EQUIPMENT and ME SYSTEMS 12 201.6ME EQUIPMENT identification, marking and docume

29、nts 13 201.7Protection against electrical HAZARDS from ME EQUIPMENT 17 201.8Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 18 201.9Protection against unwanted and excessive radiation HAZARDS 18 201.10Protection against excessive temperatures and other HAZARDS 37 201.11Accuracy

30、of controls and instruments and protection against hazardous outputs . 37 201.12HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 40 201.13PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 40 201.14Construction of ME EQUIPMENT . 40 201.15ME SYSTEMS . 40 201.16Electromagnetic compatibility

31、of ME EQUIPMENT and ME SYSTEMS 40 201.17Annex A (informative) General guidance and rationale . 41 Bibliography 42 Index of defined terms used in this particular standard 43 Table 201.101 Colours of lights and their meanings . 14 BS EN 60601-2-17:201560601-2-17 IEC:2013 3 INTERNATIONAL ELECTROTECHNIC

32、AL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardizat

33、ion 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 this end and in addition to other activities, IEC publishes Internatio

34、nal 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 Committee interested in the subject dealt with may participate in t

35、his 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) in accordance with conditions determined by agreement between the tw

36、o 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 all interested IEC National Committees. 3) IEC Publications have th

37、e 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 responsible for the way in which they are used or for any misinter

38、pretation 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 divergence between any IEC Publication and the corresponding national

39、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 marks of conformity. IEC is not responsible for any services carri

40、ed 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 experts and members of its technical committees and IEC National Comm

41、ittees 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 Publication or any other IEC Publications. 8) Attention is drawn t

42、o 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 Publication may be the subject of patent rights. IEC shall not be

43、held responsible for identifying any or all such patent rights. International standard IEC 60601-2-17 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 e

44、dition cancels and replaces the second edition, published in 2004. Consideration has been given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editi

45、ons. This edition constitutes a technical revision which brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards. BS EN 60601-2-17:2015 4 60601-2-17 IEC:2013 The text of this particular standard is based on the following documents: FDIS Report on voting 62C/575/FDIS 6

46、2C/579/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: Require

47、ments 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 PARTICULAR ST

48、ANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 201.7 includes subclauses 201.7.1, 201.7.2, etc.); “subclause” means a numbered

49、 subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all subclauses of Clause 201.7). References to clauses within this standard are preceded by the term “Clause” 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 usage described in Annex H of the ISO/