EN IEC 60601-2-46:2024
(Main)Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
IEC 60601-2-46:2023 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 pedestal of an operating table with detachable operating table top. This particular standard does not apply to - dental patient chairs (see ISO 7494-1), - examination chairs and couches, - patient-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43), - operating table heating blankets (see IEC 60601-2-35), - patient transfer equipment, - delivery tables and delivery beds, - medical beds (see IEC 60601-2-52 and EN 50637), and - field tables. IEC 60601-2-46:2023 cancels and replaces the third edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: structural alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Operationstischen
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base et les performances essentielles des tables d'opération
L'IEC 60601-2-46:2023 spécifie les exigences de sécurité applicables aux tables d'opération, que celles-ci comportent ou non des parties électriques, y compris les chariot de transfert, utilisés pour le transport du plateau de la table d'opération vers ou depuis la base ou le socle d'une table d'opération à plateau amovible. La présente norme particulière ne s’applique pas: - aux fauteuils dentaires pour patients (voir l’ISO 7494-1), - aux fauteuils et lits d'examen, - aux systèmes de support du patient des appareils de diagnostic, d’intervention et de thérapie (voir l’IEC 60601-2-54 ou l’IEC 60601-2-43), - aux couvertures chauffantes des tables d'opération (voir l’IEC 60601-2-35), - aux appareils de transfert des patients, - aux tables et lits d'accouchement, - aux lits médicaux (voir l’IEC 60601-2-52 et l’EN 50637), et - aux tables d'opération de campagne. L'IEC 60601-2-46:2023 annule et remplace la troisième édition parue en 2016. Cette édition constitue une révision technique. La présente édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente: alignement de la structure sur l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et l’IEC 60601-1:2005/AMD2:2020.
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in bistvene lastnosti operacijskih miz (IEC 60601-2-46:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-46:2022
01-maj-2022
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti operacijskih miz
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and
essential performance of operating tables
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationstischen
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base
et les performances essentielles des tables d'opération
Ta slovenski standard je istoveten z: prEN IEC 60601-2-46:2022
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN IEC 60601-2-46:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN IEC 60601-2-46:2022
oSIST prEN IEC 60601-2-46:2022
62D/1939/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-46 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-03-25 2022-06-17
SUPERSEDES DOCUMENTS:
62D/1866/CD, 62D/1935/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.
TITLE:
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential
performance of operating tables
PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
This revision project is to align with the Amendment projects of the IEC 60601 -1 series and to address some
technical updates to ED3. NCs are invited to submit their votes and comments at the CDV stage.
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You
may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permis sion
in writing from IEC.
oSIST prEN IEC 60601-2-46:2022
62D/1939/CDV – 2 – IEC CDV 60601-2-46 © IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 5
5 201.1 Scope, object and related standards . 6
6 201.2 Normative references . 8
7 201.3 Terms and definitions . 8
8 201.4 General requirements . 9
9 201.5 General requirements for testing ME EQUIPMENT . 9
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
11 201.7 ME EQUIPMENT identification, marking and documents . 9
12 201.8 Protection against electrical HAZARDS from OPERATING TABLES . 10
13 201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES and
14 ME SYSTEMS . 10
15 201.10 Protection against unwanted and excessive radiation HAZARDS . 13
16 NOTE : The collateral standard IEC 60601-1-3 is referenced in the general standard
17 and is covered under clause 203 of this document . 13
18 201.11 Protection against excessive temperatures and other HAZARDS . 13
19 201.12 Accuracy of controls and instruments and protection against hazardous
20 outputs . 13
21 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14
22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
23 201.15 Construction of ME EQUIPMENT . 14
24 201.15.4 ME EQUIPMENT components and general assembly . 14
25 201.16 ME SYSTEMS . 14
26 201.17 Electromagnetic compatibility of OPERATING TABLES and ME SYSTEMS . 14
27 202 Electromagnetic disturbances – Requirements and tests . 14
28 203 *Radiation protection in diagnostic X-ray equipment . 18
29 Annexes . 19
30 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
31 mixtures . 20
32 Annex AA (informative) Particular guidance and rationale . 21
33 Bibliography . 25
34 Index of defined terms used in this particular standard . 26
36 Figure 202.101 – ENCLOSURE ad hoc test . 16
37 Figure 202.102 – POWER SUPPLY CORD ad hoc test . 17
38 Figure 202.103 – ACCESSORy cable ad hoc test. 17
39 Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
40 application . 21
42 Table 201.101 – Determination of TENSILE SAFETY FACTOR . 12
43 Table AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
44 application . 22
oSIST prEN IEC 60601-2-46:2022
IEC CDV 60601-2-46 © IEC 2022 – 3 – 62D/1939/CDV
46 INTERNATIONAL ELECTROTECHNICAL COMMISSION
47 ____________
49 MEDICAL ELECTRICAL EQUIPMENT –
51 Part 2-46: Particular requirements for the basic safety
52 and essential performance of operating tables
54 FOREWORD
55 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization compris ing
56 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
57 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
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63 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
64 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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66 interested IEC National Committees.
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82 Publications.
83 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
84 indispensable for the correct application of this publication.
85 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
86 rights. IEC shall not be held responsible for identifying any or all such patent rights.
87 International standard IEC 60601-2-46 has been prepared by IEC subcommittee 62D
88 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
89 practice.
90 This third edition cancels and replaces the second edition published in 2010 and constitutes a
91 technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005
92 edition of IEC 60601-1, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
93 The text of this standard is based on the following documents:
FDIS Report on voting
62D/XXXX/FDIS 62D/XXXX/RVD
oSIST prEN IEC 60601-2-46:2022
62D/1939/CDV – 4 – IEC CDV 60601-2-46 © IEC 2022
95 Full information on the voting for the approval of this standard can be found in the report on
96 voting indicated in the above table.
97 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
98 In this standard, the following print types are used:
99 – Requirements and definitions: roman type.
100 – Test specifications: italic type.
101 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
102 Normative text of tables is also in a smaller type.
103 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
104 NOTED: SMALL CAPITALS.
105 In referring to the structure of this standard, the term
106 – “clause” means one of the numbered divisions within the table of contents, inclusive of all
107 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
108 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
109 subclauses of Clause 7).
110 References to clauses within this standard are preceded by the term “Clause” followed by the
111 clause number. References to subclauses within this particular standard are by number only.
112 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
113 combination of the conditions is true.
114 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
115 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
116 – “shall” means that compliance with a requirement or a test is mandatory for compliance with
117 this standard;
118 – “should” means that compliance with a requirement or a test is recommended but is not
119 mandatory for compliance with this standard;
120 – “may” is used to describe a permissible way to achieve compliance with a requirement or
121 test.
122 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
123 indicates that there is guidance or rationale related to that item in Annex AA.
124 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
125 equipment, can be found on the IEC website.
126 The committee has decided that the contents of this publication will remain unchanged until the
127 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
128 the specific publication. At this date, the publication will be
129 • reconfirmed,
...
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