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
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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
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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
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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
