1、raising standards worldwide NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI Standards Publication BS EN 60601-2-46:2011 Medical electrical equipment Part 2-46: Particular requirements for the basic safety and essential performance of operating tablesBS EN 60601-2-46:2011 B
2、RITISH STANDARD National foreword This British Standard is the UK implementation of EN 60601-2-46:2011. It is idenitical to IEC 60601-2-46:2010. It supersedes BS EN 60601-2-46:1998 which is will be withdrawn on 20 January 2014. The UK participation in its preparation was entrusted to Technical Commi
3、ttee CH/62/4, Electromedical equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 5
4、80 61510 8 ICS 11.140 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2011. Amendments issued since publication Date T e x t a f f e c t e dBS EN 6
5、0601-2-46:2011EUROPEAN STANDARD EN 60601-2-46 NORME EUROPENNE EUROPISCHE NORM August 2011 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Bru
6、ssels 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-46:2011 E ICS 11.140 Supersedes EN 60601-2-46:1998English version Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essent
7、ial performance of operating tables (IEC 60601-2-46:2010) Appareils lectromdicaux - Partie 2-46: Exigences particulires pour la scurit de base et les performances essentielles des tables dopration (CEI 60601-2-46:2010) Medizinische elektrische Gerte - Teil 2-46: Besondere Festlegungen fr die Sicherh
8、eit einschlielich der wesentlichen Leistungsmerkmale von Operationstischen (IEC 60601-2-46:2010) This European Standard was approved by CENELEC on 2011-01-20. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standar
9、d 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 Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French
10、, 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 Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bu
11、lgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 60
12、601-2-46:2011 EN 60601-2-46:2011 - 2 - Foreword The text of document 62D/870/FDIS, future edition 2 of IEC 60601-2-46, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as E
13、N 60601-2-46 on 2011-01-20. This European Standard supersedes EN 60601-2-46:1998. EN 60601-2-46:1998 was revised to align structurally with EN 60601-1:2006. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not
14、 be held responsible for identifying any or all such patent rights. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-02-20 latest date by which the national standards conf
15、licting with the EN have to be withdrawn (dow) 2014-01-20 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. Norma
16、tive text of tables 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 seventeen numbered divisions within the table of contents, inc
17、lusive 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 “Clause” followed by the clause number. Re
18、ferences to subclauses within 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/
19、IEC Directives, Part 2. For the 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 wit
20、h this standard; “may” is used 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. BS EN 606
21、01-2-46:2011- 3 - EN 60601-2-46:2011 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. Annexes ZA and ZZ have been added by CENE
22、LEC. _ Endorsement notice The text of the International Standard IEC 60601-2-46:2010 was approved by CENELEC as a European Standard without any modification. _ BS EN 60601-2-46:2011 EN 60601-2-46:2011 - 4 - Annex ZA (normative) Normative references to international publications with their correspond
23、ing European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an internatio
24、nal publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies except as follows: Publication Year Title EN/HD Year Replace IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requ
25、irements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 Add: IEC 60601-2-2 - Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of h
26、igh frequency surgical equipment and high frequency surgical accessories EN 60601-2-2 - BS EN 60601-2-46:2011- 5 - EN 60601-2-46:2011 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European C
27、ommission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive c
28、oncerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. 2 60601-2-46 IEC:2010 CONTENTS FORE WORD 3 INTRODUCTION 5 201.1 Scope, object and related standards 6 201.2 Normative references . 8 201.3 Terms and definitions
29、. 8 201.4 General requirements. 9 201.5 General requirements for testing ME EQUIPMENT 9 201.6 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 MECHANICA
30、L HAZARDS of ME EQUIPMENT and ME SYSTEMS 10 201.10 Protection against unwanted and 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 situa
31、tions and fault conditions. 13 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 13 201.15 Construction of ME EQUIPMENT . 14 201.16 ME SYSTEMS 14 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 14 202 Electromagnetic compatibility Requirements and tests 14 Annexes 16 Anne
32、x G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures 16 Annex AA (informative) Particular guidance and rationale 17 Index of defined terms used in this particular standard . 19 Figure AA.1 Recommended distribution of mass in excess of 135 kg and examples of applic
33、ation . 17 Table 201.101 Determination of TENSILE SAFETY FACTOR . 12 Table AA.1 Recommended distribution of mass in excess of 135 kg and examples of application: 18 60601-2-46 IEC:2010 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-46: Particular requirements for t
34、he basic safety and essential performance 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 c
35、o-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 Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred
36、 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, governmental and non- governmental organizations liaising with the IEC also participate in th
37、is 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 decisions or agreements of IEC on technical matters express, as nearly as possible, an internation
38、al 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 international use and are accepted by IEC National Committees in that sense. While all reasonable e
39、fforts 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 order to promote international uniformity, IEC National Committees undertake to apply IEC Public
40、ations 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 clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. I
41、ndependent 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 bodies. 6) All users should ensure that they have the latest edition of this publication. 7)
42、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, property damage or other damage of any nature whatsoever, whether direct or indirect, or for cost
43、s (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 this publication. Use of the referenced publications is indispensable for the correct applica
44、tion 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 or all such patent rights. International standard IEC 60601-2-46 has been prepared by IEC su
45、bcommittee 62D Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with t
46、he 2005 edition of IEC 60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/870/FDIS 62D/888/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. 4 60
47、601-2-46 IEC:2010 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 definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, ex
48、amples and references: in smaller type. Normative text of tables is also in a smaller type. T ERMS 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 seventeen number
49、ed 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 “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
