1、 IEC 80601-2-60 Edition 1.0 2012-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment Appareils lectromdicaux Partie 2-60: Exigences particulires pour la scurit de base et les
2、 performances essentielles des quipements dentaires IEC80601-2-60:2012THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or
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16、s: csciec.ch. IEC 80601-2-60 Edition 1.0 2012-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment Appareils lectromdicaux Partie 2-60: Exigences particulires pour la scurit d
17、e base et les performances essentielles des quipements dentaires INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE V ICS 11.040.01 PRICE CODE CODE PRIX ISBN 978-2-88912-914-0 Warning! Make sure that you obtained this publication from an authorized distributor. Atte
18、ntion! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 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 8 201.5 General requirements for
19、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 SYSTEMS 14 201.10 Protectio
20、n 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 . 20 201.14 PROGRAMMABLE ELECTRICAL M
21、EDICAL 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) Particular guidance and rationale 22
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 Loading fan construction. 29 Fig
23、ure 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 temperatures for DENTAL HANDPIECE .
24、 17 80601-2-60 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 Commission (IEC) is a worldwide organization for sta
25、ndardization 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 I
26、nternational 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 partici
27、pate 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 accordance with conditions determined by agreement betwe
28、en 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 interested IEC National Committees. 3) IEC Publication
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31、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 conformity. IEC is not responsible for any servi
32、ces 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 members of its technical committees and IEC Nati
33、onal 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 Publication or any other IEC Publications. 8) Attention i
34、s 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 Publication may be the subject of patent rights. IEC shal
35、l 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: Electrical equipment in medical practice and subcommi
36、ttee 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 particular standard can be found in the report on votin
37、g 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. 4 80601-2-60 IEC:2012 In this standard, the following print types are used: Requirements and defin
38、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. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NO
39、TED: 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
40、.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” 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 “inclu
41、sive 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/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a t
42、est is mandatory 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
43、first character 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.
44、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 publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revi
45、sed edition, or amended. 80601-2-60 IEC:2012 5 MEDICAL ELECTRICAL EQUIPMENT Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment 201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except as follows: 201.1.1 Scope Repl
46、acement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES and DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. Excluded are amalgamators, sterilizers and dental X-ray equipment. If a clause
47、or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the int
48、ended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. 201.1.2 Object Replacement: The object of this particu
49、lar standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for DENTAL EQUIPMENT (as defined in 201.3.202.) 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3, IEC 60601-1-92)and IEC 60601-1-103)do not apply. All other published colla
