1、BSI Standards PublicationMedical electrical equipmentPart 2-18: Particular requirements for thebasic safety and essential performance of endoscopic equipmentBS EN 60601-2-18:2015National forewordThis British Standard is the UK implementation of EN 60601-2-18:2015. It is identical to IEC 60601-2-18:2
2、009. It supersedes BS EN 60601-2-18:1997 which is withdrawn.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4,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 organizations represented on this committee can be obtai
3、ned 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 52903 0ICS 11.040.50Compliance with a
4、 British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-18:2015EUROPEAN STAND
5、ARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-18 October 2015 ICS 11.040.50 Supersedes EN 60601-2-18:1996 English Version Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (IEC 60601-2-18:2009) Appareils lectromd
6、icaux - Partie 2-18: Exigences particulires pour la scurit de base et les performances essentielles des appareils dendoscopie (IEC 60601-2-18:2009) Medizinische elektrische Gerte - Teil 2-18: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von endoskopischen
7、 Gerten (IEC 60601-2-18:2009) 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. Up-to-d
8、ate 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 transl
9、ation 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 Republic, De
10、nmark, 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. European
11、 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 worldwide fo
12、r CENELEC Members. Ref. No. EN 60601-2-18:2015 E BS EN 60601-2-18:2015EN 60601-2-18:2015 2 European foreword The text of document 62D/682/CDV, future edition 3 of IEC 60601-2-18, prepared by SC 62D “Electromedical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to t
13、he IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-18:2015. 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) 2016-06-15 latest date by which the national s
14、tandards conflicting with the document have to be withdrawn (dow) 2018-09-15 This document supersedes EN 60601-2-18:1996. 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 responsible for identif
15、ying 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 informative Annex ZZ,
16、 which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-18:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated
17、 : IEC 60601-2-57 NOTE Harmonized as EN 60601-2-57. BS EN 60601-2-18:2015EN 60601-2-18:2015 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 docume
18、nt 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 modifications, indicated
19、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 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replacement in Annex ZA of EN 60601-1
20、:2006: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 - - + corrigendum Mar. 2010 Addition to Annex ZA of EN 60601-1:2006
21、: IEC 60601-2-2 2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories EN 60601-2-2 2009 - - + A11 2011 IEC 60601-2-37 - Medical electrical equipment - Part 2-37
22、: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment EN 60601-2-37 - ISO 8600-1 - Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements - - BS EN 60601-2-18:2015EN 60601-2-18:2015
23、 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 the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements giv
24、en 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 concerned. WARNING: Other requirements and other EU Directives can be applied to the products
25、falling within the scope of this standard. BS EN 60601-2-18:2015 2 60601-2-18 IEC:2009CONTENTSFOREWORD.4INTRODUCTION.6201.1 Scope, objectand related standards.8201.2 Normative references9201.3Terms and definitions10201.4 General requirements12201.5General requirements for testingof ME EQUIPMENT .142
26、01.6 Classification of ME EQUIPMENT and ME SYSTEMS 14201.7 M E EQUIPMENT identification, marking and documents14201.8 Protection against electrical HAZARDS from ME EQUIPMENT 18201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 19201.10 Protection against unwanted and excessiv
27、e radiation HAZARDS 20201.11 Protection againstexcessive temperatures and other HAZARDS21201.12 Accuracy ofcontrols and instruments and protection a gainst hazardousoutputs24201.13 H AZARDOUS SITUATIONS and fault conditions.25201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS).25201.15 Construct
28、ion of ME EQUIPMENT .25201.16 M ESYSTEMS 26201.17 Electromagneticcompatibilityof ME EQUIPMENT and ME SYSTEMS .26202Electromagnetic compatibility Requirements and tests.26Annexes.27Annex C (informative)Guide tomarking and labelling requirements for ME EQUIPMENTand ME SYSTEMS 27Annex D (informative) S
29、ymbols on marking29AnnexJ(informative) Survey of insulation paths31AnnexAA (informative)Particular guidance and rationale33AnnexBB (informative)Clauses of this standardaddressing essentialprinciples ofsafety and performance of medicaldevices (GHTF/SG1/N41R9:2005)43Indexof defined terms used in thisp
30、articular standard45Figure 201.101 Identification of LIGHT EMISSIONPART 12Figure 201.102 Measurement of CAPACITIVELY - COUPLED HF CURRENT from conductiveparts of an ENDOSCOPE24Figure 201.J.101 Insulation example 101.31Figure 201.J.102 Insulation example 102.32Figure 201.J.103 Insulation example 103.
31、32Figure AA.101 Illustration of typical CONFIGURATION FOR ENDOSCOPIC APPLICATION 34Table 201.101 Listof ESSENTIAL PERFORMANCE requirements .13BS EN 60601-2-18:201560601-2-18 IEC:2009 3 Table 201.C.101 Marking on the outside of ENDOSCOPIC EQUIPMENT or its parts27Table 201.C.102 Marking on the inside
32、of ENDOSCOPIC EQUIPMENT or its parts27Table 201.C.104 A CCOMPANYING DOCUMENTS, general28Table 201.C.105 A CCOMPANYING DOCUMENTS, instructionsfor use28Table 201.D.101 Symbols for marking ENDOSCOPIC EQUIPMENT or its parts29Table BB.1 Correspondencebetween this standard and GHTF/SG1/N41R9:200543BS EN 6
33、0601-2-18:2015 4 60601-2-18 IEC:2009INTERNATIONAL ELECTROTECHNICAL COMMISSION_ MEDICAL ELECTRICAL EQUIPMENT Part 2-18: Particular requirements for the basic safetyand essential performance of endoscopic equipmentFOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organizat
34、ion for standardization comprisingall national electrotechnicalcommittees (IEC National Committees). The object of IEC is to promoteinternational co-operation on all questions concerning standardization in the electrical and electronic fields. Tothis end and in addition to other activities, IEC publ
35、ishes International Standards, Technical Specifications,Technical Reports, and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subjectdealt with may participate in thispreparatory work. Inter
36、national, governmental and non-governmental organizations liaising with the IEC alsoparticipate 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
37、 decisions or agreements of IEC on technical matters express, as nearlyas possible, an internationalconsensus of opinion on the relevant subjects since each technical committee has representation from allinterested IEC National Committees. 3) IEC Publications have the form of recommendations for int
38、ernational use and are accepted by IEC NationalCommittees in that sense. While all reasonable efforts are made to ensure that the technical content of IECPublications is accurate, IEC cannot be held responsible for the way in which theyare used or for anymisinterpretation by any end user.4) In order
39、 to promote international uniformity, IEC NationalCommittees undertake to apply IEC Publicationstransparently to the maximum extent possible in their national and regional publications. Any divergencebetween any IEC Publication and the corresponding national or regional publication shall be clearly
40、indicated inthe latter.5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for anyequipment declared to be in conformitywith an IEC Publication.6) All users should ensure that they have the latest edition of this publication.7) No liability shall attach t
41、o IEC or its directors, employees, servants or agents including individual experts andmembers of its technical committees and IEC National Committees for any personal injury, property damage orother damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
42、expenses arising out of the publication, use of,or reliance upon, this IEC Publication or any other IECPublications.8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications isindispensable for the correct application of this publication.9) Atten
43、tion is drawn to the possibility that some of the elements of this IEC Publication may be the subject ofpatent rights. IEC shall not be held responsible for identifying any or all such patent rights.International standard IEC 60601-2-18 has been prepared by IECsubcommittee 62D:Electromedical equipme
44、nt, of IECtechnical committee 62, Electrical equipment inmedical practice. This third edition cancels and replacesthe second edition,published in 1996, and itsAmendment 1 (2000). This edition constitutes a technical revision and has been aligned orharmonized with IEC 60601-1:2005.Themain changes wit
45、h respect tothe previous edition include:a) alignment ofrequirements withIEC 60601-1:2005;b) inclusion of essential performance requirements;c) the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope ofthe standard;d) refe
46、rence to IEC 60601-2-2 forthe dielectricstrength testing of HF energized endotherapydevices, rather than defining different tests.BS EN 60601-2-18:201560601-2-18 IEC:2009 5 The text ofthis particular standard is based on the following documents:Enquiry draftReport on voting62D/682/CDV 62D/743/RVC Fu
47、ll information on the voting forthe approval of this part icular standard can be found in th e report on voting indicated in the above table.This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.In thisstandard, the following print types are used: Requirements and defin
48、itions: 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. T ERMS DEFINED IN C LAUSE 3 OF THE GENERAL STANDARD , IN THIS PARTICULAR STANDARD OR AS
49、NOTED: SMALL CAPITALS . In referring to the structure of this standard, the term“clause” means one of theseventeen numbered divis ions within the table of contents,inclusive ofall subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means anumbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 areallsubclauses of Clause 7).References to clauses within this standard are preceded by the term “Clause” followed by the clause number.References to subclauses with
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