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    IEC 60601-2-46-2016 Medical electrical equipment - Part 2-46 Particular requirements for the basic safety and essential performance of operating tables《医用电气设备 第2-46部分 手术台基本安全性和必要性能的详细要求》.pdf

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    IEC 60601-2-46-2016 Medical electrical equipment - Part 2-46 Particular requirements for the basic safety and essential performance of operating tables《医用电气设备 第2-46部分 手术台基本安全性和必要性能的详细要求》.pdf

    1、 IEC 60601-2-46 Edition 3.0 2016-08 REDLINE VERSION Medical electrical equipment Part 2-46: Particular requirements for the basic safety and essential performance of operating tables IEC 60601-2-46:2016-08 RLV(en) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2016 IEC, Geneva, Swit

    2、zerland 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 mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the count

    3、ry of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varem

    4、b Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publ

    5、ications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. IEC Catalogue - webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibl

    6、iographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents. Available for PC, Mac OS, Android Tablets and iPad. IEC publications search - www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criteria (r

    7、eference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available online and also on

    8、ce a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing 20 000 terms and definitions in English and French, with equivalent terms in 15 additional languages. Also known as the International Electrotechnical Vocabular

    9、y (IEV) online. IEC Glossary - std.iec.ch/glossary 65 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002. Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IEC C

    10、ustomer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. IEC 60601-2-46 Edition 3.0 2016-08 REDLINE VERSION Medical electrical equipment Part 2-46: Particular requirements

    11、for the basic safety and essential performance of operating tables INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.140 ISBN 978-2-8322-3581-2 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. c

    12、olour inside 2 IEC 60601-2-46:2016 RLV IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 9 201.3 Terms and definitions 9 201.4 General requirements . 10 201.5 General requirements for testing ME EQUIPMENT OPERATING TABLES 10 201.

    13、6 Classification of ME EQUIPMENT OPERATING TABLES and ME SYSTEMS 10 201.7 ME EQUIPMENT OPERATING TABLES identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT OPERATING TABLES . 11 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT OPERATING T

    14、ABLES and ME SYSTEMS 11 201.10 Protection against unwanted and excessive radiation HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 15 201.13 HAZARDOUS SITUATIONS and fault cond

    15、itions for OPERATING TABLES . 15 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15 201.15 Construction of ME EQUIPMENT OPERATING TABLES 15 201.16 ME SYSTEMS 15 201.17 Electromagnetic compatibility of ME EQUIPMENT OPERATING TABLES and ME SYSTEMS . 16 202 Electromagnetic compatibility disturb

    16、ances Requirements and tests . 16 203 Radiation protection in diagnostic X-ray equipment 20 Annexes . 21 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures 22 Annex AA (informative) Particular guidance and rationale 23 Bibliography 25 Index of defined terms

    17、used in this particular standard 26 Figure 202.101 ENCLOSURE ad hoc test 18 Figure 202.102 POWER SUPPLY CORD ad hoc test 19 Figure 202.103 ACCESSORy cable ad hoc test. 19 Figure AA.1 Recommended distribution of mass in excess of 135 kg and examples of application 23 Table 201.101 Determination of TE

    18、NSILE SAFETY FACTOR . 13 Table AA.1 Recommended distribution of mass in excess of 135 kg and examples of application 24 IEC 60601-2-46:2016 RLV IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-46: Particular requirements for the basic safety and essential pe

    19、rformance of operating tables FOREWORD 1) The International Electrotechnical Commission (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 con

    20、cerning standardization in the electrical and electronic fields. To this end and 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)”). Th

    21、eir preparation is entrusted to technical committees; any IEC National Committee 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

    22、 closely with the International Organization for Standardization (ISO) in accordance 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 r

    23、elevant subjects since each technical committee has representation from all interested 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 t

    24、he 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 order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maxi

    25、mum extent possible in their national and regional publications. Any divergence between 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

    26、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 bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC

    27、 or its directors, employees, servants or agents including individual experts and 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 exp

    28、enses 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 this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Att

    29、ention 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 or all such patent rights. DISCLAIMER This Redline version is not an official IEC Standard and is intended only to provide t

    30、he user with an indication of what changes have been made to the previous version. Only the current version of the standard is to be considered the official document. This Redline version provides you with a quick and easy way to compare all the changes between this standard and its previous edition

    31、. A vertical bar appears in the margin wherever a change has been made. Additions are in green text, deletions are in strikethrough red text. 4 IEC 60601-2-46:2016 RLV IEC 2016 International standard IEC 60601-2-46 has been prepared by IEC subcommittee 62D Electromedical equipment, of IEC technical

    32、committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2010 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1 and with IEC 60601-1:2005/A

    33、MD1:2012. The text of this standard is based on the following documents: FDIS Report on voting 62D/1365/FDIS 62D/1371/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordanc

    34、e with the ISO/IEC Directives, Part 2. In this 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

    35、 is also in a smaller type. TERMS DEFINED IN 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 numbered divisions within the table of contents, inclusive of all subdivisions (e

    36、.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 “Clause” followed by the clause number. References to subclauses within

    37、 this particular 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/IEC Directives, Part 2. For t

    38、he purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test 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 use

    39、d to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the 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. IEC 60601-2-46:2016 RLV IEC 2016 5 A l

    40、ist of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore

    41、.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The “colour inside” logo on the cover page of this publication indicates that it contains colours which are considered to be us

    42、eful for the correct understanding of its contents. Users should therefore print this publication using a colour printer. 6 IEC 60601-2-46:2016 RLV IEC 2016 INTRODUCTION This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of OPERATING TABLES. It amends and supplements IEC 60

    43、601-1 (third edition, 2005): Medical electrical equipment Part 1: General requirements for basic safety and essential performance) and its Amendment 1 (IEC 60601-1:2005/AMD1:2012), hereinafter referred to as the general standard. The aim of this third edition is to bring this particular standard up

    44、to date with reference to the third edition of the general standard through reformatting and technical changes. The requirements of this particular standard take priority over those of the general standard. A “General guidance and rationale” for the more important requirements of this particular sta

    45、ndard is included in Annex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technolog

    46、y. However, Annex AA does not form part of the requirements of this Standard. IEC 60601-2-46:2016 RLV IEC 2016 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-46: Particular requirements for the basic safety and essential performance of operating tables 201.1 Scope, object and related standards Clause 1 of th

    47、e general standard 1)applies, except as follows: 201.1.1 Scope Replacement: This particular standard specifies safety requirements for OPERATING TABLES, whether or not having electrical parts, including TRANSPORTERS, used for the transportation of the OPERATING TABLE top to or from the base or pedes

    48、tal of an OPERATING TABLE with detachable OPERATING TABLE top. NOTE See also 4.2 of the General Standard. This particular standard does not apply to dental PATIENT chairs; examination chairs and couches; PATIENT-supporting systems of diagnostic and therapeutic devices; (see IEC 60601-2-43) OPERATING

    49、 TABLE heating blankets; (see IEC 80601-2-35) PATIENT transfer equipment; delivery tables and beds; medical beds; (see IEC 60601-2-52) field tables. NOTE If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the relevant requirements of each related particular standard have to be considered are also applicable. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL


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