BS EN 60601-2-36-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy《医疗电气.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsyBS EN 60601-2-36:2015National forewordThis British Standard is the UK implementation of EN 60601-2-36:2015. It i

2、sidentical to IEC 60601-2-36:2014. It supersedes BS EN 60601-2-36:1997,which will be withdrawn on 22 May 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of organi

3、zations 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 Standards Limited 2015IS

4、BN 978 0 580 76697 8ICS 11.040.60Compliance 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 affectedBRITI

5、SH STANDARDBS EN 60601-2-36:2015EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 60601-2-36 May 2015 ICS 11.040.01 Supersedes EN 60601-2-36:1997 English Version Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment forextracorp

6、oreally induced lithotripsy (IEC 60601-2-36:2014) Appareils lectromdicaux - Partie 2-36: Exigencesparticulires pour la scurit de base et les performancesessentielles des appareils pour lithotritie cre de faonextracorporelle (IEC 60601-2-36:2014) Medizinische elektrische Gerte - Teil 2-36: BesondereF

7、estlegungen fr die Sicherheit einschlielich derwesentlichen Leistungsmerkmal von Gerten zur extrakorporal induzierten Lithotripsie (IEC 60601-2-36:2014) This European Standard was approved by CENELEC on 2014-05-15. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which s

8、tipulate the conditions for giving this European Standard the status of a national 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 Eur

9、opean Standard exists in three official versions (English, French, German). A version in any other language made by translationunder 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 mem

10、bers are the national electrotechnical committees of Austria, Belgium, Bulgaria, 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, No

11、rway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue

12、 Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-36:2015 E EN 60601-2-36:2015 (E) 2 Foreword The text of document 62D/1109/FDIS, future edition 2 of IEC 60601-2-36, prepared by IEC/SC 62D “Ele

13、ctromedical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-36:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an

14、identical national standard or by endorsement (dop) 2015-11-22 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-05-22 This document supersedes EN 60601-2-36:1997. Attention is drawn to the possibility that some of the elements of this document

15、 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

16、ts of EU Directive(s). For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-36:2014 was approved by CENELEC as a European Standard without any modification. In the official v

17、ersion, for Bibliography, the following notes have to be added for the standards indicated: IEC 61689:2013 NOTE Harmonized as EN 61689:2013 (not modified). IEC 62555 NOTE Harmonized as EN 62555. BS EN 60601-2-36:2015EN 60601-2-36:2015 (E) 3 Annex ZA (normative) Normative references to international

18、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 references, the latest edition of the ref

19、erenced 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 listed in this annex is available he

20、re: www.cenelec.eu Annex ZA of EN 60601-1:2006 applies with the following exceptions: Publication Year Title EN/HD Year Replacement: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagneti

21、c compatibility - Requirements and tests EN 60601-1-2 2007 +AC 2010 Addition: IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 +AC 2010 +AC 2014 +A11 2011 +A1 2012 +A1 2013 IEC 60601-2-5 2009 Medical electrical eq

22、uipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment - - IEC 61846 1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields EN 61846 1998 BS EN 60601-2-36:2015EN 60601-2-36:2015 (E) 4 Annex ZZ (informative

23、) 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 Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Dire

24、ctive 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 concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope

25、 of this standard. BS EN 60601-2-36:2015 2 IEC 60601-2-36:2014 IEC 2014 CONTENTS FOREWORD . 3 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements 10 201.5 General requirements for testing ME EQUIPMENT .

26、10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS . 12 201.10 Protection against unwanted an

27、d excessive radiation HAZARDS 13 201.11 Protection against excessive temperatures and other HAZARDS 13 201.12 Accuracy of controls and instruments and protection against hazardous outputs 13 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14 201.14 PROGRAMMABLE ELECTRICAL MEDICAL

28、 SYSTEMS (PEMS) . 15 201.15 Construction of ME EQUIPMENT . 15 201.16 ME SYSTEMS . 15 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 15 202 * ELECTROMAGNETIC COMPATIBILITY Requirements and tests 15 Annexes . 15 Annex AA (informative) Particular guidance and rationale 16 Annex B

29、B (informative) Definition of coordinates, FOCUS and TARGET LOCATION 17 Bibliography 18 Index of defined terms used in this particular standard 20 Figure BB.1 Geometrical FOCUS distribution . 17 BS EN 60601-2-36:2015IEC 60601-2-36:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL E

30、LECTRICAL EQUIPMENT Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrot

31、echnical 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 Specificati

32、ons, 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,

33、 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 two organizations. 2) The formal decis

34、ions 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 intern

35、ational 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 ord

36、er 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 or regional publication shall be cle

37、arly 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

38、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 Committees for any personal injury, prop

39、erty 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

40、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 held responsible for identifying any

41、 or all such patent rights. International standard IEC 60601-2-36 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 19

42、97. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment 1:2012). BS EN 60601-2-36:2015 4 IEC 60601-2-36:2014 IEC 2014 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/1109/FDIS 62D/1122/RVD Ful

43、l 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 defi

44、nitions: 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 STANDARD OR AS N

45、OTED: 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 of a clause (e.g. 7.1,

46、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 used as an “inclusive or”

47、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 requirement or a test is ma

48、ndatory 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. An asterisk (*) as the first cha

49、racter of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. 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. BS EN 60601-2-36:2015IEC 60601-2-36:2014 IEC 2014 5 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:/w