EN 80601-2-60-2015 en Medical electrical equipment - Part 2-60 Particular requirements for the basic safety and essential performance of dental equipment.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-60: Particular requirements for the basic safety and essential performance of dental equipmentBS EN 80601-2-60:2015National forewordThis British Standard is the UK implementation of EN 80601-2-60:2015. It isidentical to IEC 80601-2-60:2012.

2、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 obtained onrequest to its secretary.This publication does not pur

3、port 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 63741 4ICS 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligatio

4、ns.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 80601-2-60:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 80601-2-60 May 2015 ICS 1

5、1.040.01 English Version Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (IEC 80601-2-60:2012) Appareils lectromdicaux - Partie 2-60: Exigences particulires pour la scurit de base et les performances essentielles de

6、s quipements dentaires (IEC 80601-2-60:2012) Medizinische elektrische Gerte - Teil 2-60: Besondere Festlegungen an die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Dental-Gerten (IEC 80601-2-60:2012) This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are

7、 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 bibliographical references concerning such national standards may be obtained on application to t

8、he 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 the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Manage

9、ment 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, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Irel

10、and, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Kom

11、itee 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 Members. Ref. No. EN 80601-2-60:2015 E BS EN 80601-2-60:2015EN 80601-2-60:2015 (E) 2 Foreword The tex

12、t of document 62D/964/FDIS, future edition 1 of IEC 80601-2-60, prepared by SC 62D, “Electromedical equipment“, of IEC/TC 62, “Electrical equipment in medical practice“ and SC 6 “Dental equipment“ of ISO/TC 106 “Dentistry“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN

13、80601-2-60:2015. 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 by which the national standards conflicting with the document have to be withdrawn

14、 (dow) 2018-04-14 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 identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by

15、the European Commission and the European Free Trade Association, and supports essential requirements 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 80601-2-

16、60:2012 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 61810-7:2006 NOTE Harmonized as EN 61810-7:2006 (not modified). ISO 13732-1:2006 NOTE Harmonized as EN ISO

17、 13732-1:2008 (not modified). ISO 17664:2004 NOTE Harmonized as EN ISO 17664:2004 (not modified). ISO 7494-2:2003 NOTE Harmonized as EN ISO 7494-2:2003 (not modified). ISO 21530:2004 NOTE Harmonized as EN ISO 21530:2004 (not modified). BS EN 80601-2-60:2015EN 80601-2-60:2015 (E) 3 Annex ZA (normativ

18、e) 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 edition cited applies. For undated

19、references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies with the following exceptions: Publicati

20、on Year Title EN/HD Year Replacement: IEC 60664-1 2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests EN 60664-1 2007 IEC 60825-1 - Safety of laser products - Part 1: Equipment classification and requirements EN 60825-1 - Addition: IEC 6

21、0601-2-2 2009 Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories EN 60601-2-2 + A11 2009 2011 IEC 60601-2-22 2007 Medical electrical equipment - Part 2-22: Particular

22、 requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment - - IEC 60601-2-57 2011 Medical electrical equipment - Part 2-57: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for thera

23、peutic, diagnostic, monitoring and cosmetic/aesthetic use EN 60601-2-57 2011 IEC 60664-4 2005 Insulation coordination for equipment within low-voltage systems - Part 4: Consideration of high-frequency voltage stress EN 60664-4 + corr. October 2006 2006 IEC 61180-1 - High-voltage test techniques for

24、low-voltage equipment - Part 1: Definitions, test and procedure requirements EN 61180-1 - IEC 61180-2 - High-voltage test techniques for low-voltage equipment - Part 2: Test equipment EN 61180-2 - IEC 61810-1 + corr. February 2008 2010 Electromechanical elementary relays - Part 1: General requiremen

25、ts EN 61810-1 2008 IEC 62471 - Photobiological safety of lamps and lamp systems EN 62471 - ISO 1942 - Dentistry - Vocabulary EN ISO 1942 - BS EN 80601-2-60:2015EN 80601-2-60:2015 (E) 4 Publication Year Title EN/HD Year ISO 7785-2 - Dental handpieces - Part 2: Straight and geared angle handpieces EN

26、ISO 7785-2 - BS EN 80601-2-60:2015EN 80601-2-60:2015 (E) 5 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

27、 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 concerned. WARNING: Other requirements

28、 and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 80601-2-60:2015 2 80601-2-60 IEC:2012 CONTENTS FOREWORD . 3 201.1 Scope, object and related standards 5 201.2 Normative references 6 201.3 Terms and definitions 7 201.4 General requirements 8 201

29、.5 General requirements for testing of ME EQUIPMENT . 8 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 9 201.7 ME EQUIPMENT identification, marking and documents 9 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 10 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME

30、 SYSTEMS 14 201.10 Protection against unwanted and excessive radiation HAZARDS 16 201.11 Protection against excessive temperatures and other HAZARDS 16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 20 201.13 HAZARDOUS SITUATIONS and fault conditions . 20 201.

31、14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21 201.15 Construction of ME EQUIPMENT . 21 201.16 ME SYSTEMS. 21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 21 201.101 Cordless HAND-HELD and foot-operated control devices . 21 Annexes . 21 Annex AA (informative) Particula

32、r guidance and rationale 22 Bibliography 31 Index of defined terms used in this particular standard 32 Figure AA.1 Example of APPLIED PARTS for DENTAL EQUIPMENT 23 Figure AA.2 Calculation of LEAKAGE CURRENT . 24 Figure AA.3 Insulation problem of commutator DENTAL ELECTRICAL MOTOR 25 Figure AA.4 Load

33、ing fan construction. 29 Figure AA.5 Load diagram with loading fan 30 Table 201.101 Test voltages for solid insulation for SECONDARY CIRCUITS according to 201.8.5.2 10 Table 201.102 Determination of TENSILE SAFETY FACTOR . 15 Table 201.103 Mass distribution 16 Table 201.104 Allowable maximum tempera

34、tures for DENTAL HANDPIECE . 17 BS EN 80601-2-60:201580601-2-60 IEC:2012 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment FOREWORD 1) The International Electrotechnical Com

35、mission (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 this end and

36、 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 Committee

37、 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) in accorda

38、nce 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 all inter

39、ested 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 responsi

40、ble 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 divergence b

41、etween 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 marks of

42、 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 experts and

43、 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 Publicat

44、ion 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 Publicat

45、ion may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 80601-2-60 has been prepared by a Joint Working Group of subcommittee 62D: Electrical equipment in medical practice of IEC technical committee 62: Elec

46、trical equipment in medical practice and subcommittee 6: Dental equipment of ISO technical committee 106: Dentistry. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/964/FDIS 62D/984/RVD Full information on the voting for the approval of this partic

47、ular standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 16 P-members out of 17 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. BS EN 80601-2-60:2015 4 80601-2-60 IEC:2012 In th

48、is 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 references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN

49、 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 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 “