SIST EN IEC 60601-2-46:2020

SLOVENSKI STANDARD
SIST EN IEC 60601-2-46:2020
01-januar-2020
Nadomešča:
SIST EN 60601-2-46:2011
Medicinska električna oprema - 2-46. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti operacijskih miz (IEC 60601-2-46:2016)
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and
essential performance of operating tables (IEC 60601-2-46:2016)
Medizinische elektrische Geräte - Teil 2-46: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationstischen (IEC 60601-2
-46:2016)
Appareils électromédicaux - Partie 2-46: Exigences particulières pour la sécurité de base
et les performances essentielles des tables d'opération (IEC 60601-2-46:2016)
Ta slovenski standard je istoveten z: EN IEC 60601-2-46:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN IEC 60601-2-46:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-46:2020

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SIST EN IEC 60601-2-46:2020


EUROPEAN STANDARD EN IEC 60601-2-46

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2019
ICS 11.140 Supersedes EN 60601-2-46:2011 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-46: Particular requirements
for the basic safety and essential performance of operating
tables
(IEC 60601-2-46:2016)
Appareils électromédicaux - Partie 2-46: Exigences Medizinische elektrische Geräte - Teil 2-46: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des tables d'opération wesentlichen Leistungsmerkmale von Operationstischen
(IEC 60601-2-46:2016) (IEC 60601-2-46:2016)
This European Standard was approved by CENELEC on 2016-09-14. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-46:2019 E

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SIST EN IEC 60601-2-46:2020
EN IEC 60601-2-46:2019 (E)
European foreword
The text of document 62D/1365/FDIS, future edition 3.0 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 approved by CENELEC as EN IEC 60601-2-46:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-05-15
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-11-15
document have to be withdrawn

This document supersedes EN 60601-2-46:2011 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 60601-2-46:2016 was approved by CENELEC as a
European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1-8 NOTE Harmonized as EN 60601-1-8
IEC 60601-1-10:2007 NOTE Harmonized as EN 60601-1-10:2008 (not modified)
IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified)
IEC 60601-1-12:2014 NOTE Harmonized as EN 60601-1-12:2015 (not modified)
IEC 80601-2-35 NOTE Harmonized as EN 80601-2-35

2

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SIST EN IEC 60601-2-46:2020
EN IEC 60601-2-46:2019 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Replacement
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
  +EN 60601-1-2010
3:2008/corrigendum
Mar. 2010
  +A11 2016
Addition
IEC 60601-2-2 -  Medical electrical equipment - Part 2-2: EN IEC 60601-2-2 -
Particular requirements for the basic safety
and essential performance of high
frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-43 -  Medical electrical equipment - Part 2-43: EN 60601-2-43 -
Particular requirements for the basic safety
and essential performance of X-ray
equipment for interventional procedures
  +AC 2014

3

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SIST EN IEC 60601-2-46:2020



IEC 60601-2-46

®


Edition 3.0 2016-08




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical electrical equipment –

Part 2-46: Particular requirements for the basic safety and essential performance

of operating tables




Appareils électromédicaux –

Partie 2-46: Exigences particulières pour la sécurité de base et les performances


essentielles des tables d'opération













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.140 ISBN 978-2-8322-3565-2



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing OPERATING TABLES . 9
201.6 Classification of OPERATING TABLES and ME SYSTEMS . 9
201.7 OPERATING TABLES identification, marking and documents. 9
201.8 Protection against electrical HAZARDS from OPERATING TABLES . 10
201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES 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 SITUATIONS and fault conditions for OPERATING TABLES . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
201.15 Construction of OPERATING TABLES . 14
201.16 ME SYSTEMS . 14
201.17 Electromagnetic compatibility of OPERATING TABLES and ME SYSTEMS . 14
202 Electromagnetic disturbances – Requirements and tests . 14
203 Radiation protection in diagnostic X-ray equipment . 18
Annexes . 19
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 20
Annex AA (informative) Particular guidance and rationale . 21
Bibliography . 23
Index of defined terms used in this particular standard . 24

Figure 202.101 – ENCLOSURE ad hoc test . 16
Figure 202.102 – POWER SUPPLY CORD ad hoc test . 17
Figure 202.103 – ACCESSORy cable ad hoc test . 17
Figure AA.1 – Recommended distribution of mass in excess of 135 kg and examples of
application . 21

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 . 22

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IEC 60601-2-46:2016  IEC 2016 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-46: Particular requirements for the 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 co-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 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 this 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 international
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 efforts 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 Publications
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. Independent 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) 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 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 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) 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 subcommittee 62D
Electromedical equipment, of IEC technical 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/AMD1:2012.
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.

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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, 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
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.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” 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 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 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.
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.
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.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.

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IEC 60601-2-46:2016  IEC 2016 – 5 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of OPERATING
TABLES. It amends and supplements IEC 60601-1 (third edition, 2005) 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 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
standard 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 technology. However, Annex AA does not form part of the requirements of
this Standard.

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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
1)
Clause 1 of the general standard 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 pedestal 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 TABLE heating blankets; (see IEC 80601-2-35)
– PATIENT transfer equipment;
– delivery tables and beds;
– medical beds; (see IEC 60601-2-52)
– field tables.
If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the
relevant requirements of each related particular standard are also applicable.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for OPERATING TABLES as defined in 201.3.201.
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.
______________
1)
The general standard is IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance.

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IEC 60601-2-46:2016  IEC 2016 – 7 –
IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203 respectively.
IEC 60601-1-8, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not apply. All other
published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular ME
EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC
60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

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201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-
ray equipment
2
IEC 60601-1-3:2008/AMD1:2013
Addition:
IEC 60601-2-2, Medical electrical equipment – Part 2-2: Particular requirements for the basic
safety and essential performance of high frequency surgical equipment and high frequency
surgical accessories
IEC 60601-2-43, Medical electrical equipment – Part 2-43: Particular requirements for the
basic safety and essential performance of X-ray equipment for interventional procedures
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1 apply,
except as follows:
NOTE An index of defined terms is found beginning on page 24.
Addition:
201.3.201
MOBILE OPERATING TABLE
OPERATING TABLE intended to be relocated from one location to another while supported by its
own wheels or equivalent means
201.3.202
NORMAL POSITION
position of the OPERATING TABLE top with all sections set in the horizontal position
201.3.203
OPERATING TABLE
device with the INTENDED USE of supporting and positioning a PATIENT during surgical
procedures for not more than 24 h
Note 1 to entry: This includes pre- and post-operative phases in general, surgical/medical procedures under
medical supervision.
______________
2
 There exists a consolidated edition 2.1, which includes IEC 60601-1-3:2008 and its Amendment 1 (2013).

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IEC 60601-2-46:2016  IEC 2016 – 9 –
201.3.204
TRANSPORTER
device intended for the transportation of an OPERATING TABLE top to or from the base or
pedestal of an OPERATING TABLE, or the transportation of the OPERATING TABLE top complete
with the base
Note 1 to entry: This definition does not include devices intended to simplify the transport of the PATIENT from one
location to another without the transfer of parts associated with an OPERATING TABLE.
Note 2 to entry: The transportation can be done with or without a PATIENT in place.
201.3.205
TRENDELENBURG POSITION
a supine PATIENT position where the body is in a single plane, with that plane inclined so that
the head is lower than the pelvis
201.4 General requirements
Clause 4 of the general standard applies, except as follows.
201.4.3 Essential performance
Addition:
Besides the definition of the MANUFACTURER, the following ESSENTIAL PERFORMANCE is required
from OPERATING TABLES:
– supporting a PATIENT without unwanted movement in a SINGLE FAULT CONDITION.
201.4.7 SINGLE FAULT CONDITION for OPERATING TABLES
Addition:
Additional SINGLE FAULT CONDITIONS to be regarded with OPERATING TABLES:
• flaw (impairment) in the transmission of commands from/to input devices.
The MANUFACTURER should provide means, where practical, to ensure that in a SINGLE FAULT
CONDITION the PATIENT support platform of the OPERATING TABLE can return to a position for
emergency treatment.
NOTE 101 Examples of positions for emergency treatment are TRENDELENBURG or positions for cardiopulmonary
resuscitation (CPR), emergency back flattening.
201.5 General requirements for testing OPERATING TABLES
Clause 5 of the general standard applies.
201.6 Classification of OPERATING TABLES and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 OPERATING TABLES identification, marking and documents
Clause 7 of the general standard applies, except as follows:

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201.7.2 Marking on the outside of OPERATING TABLES or OPERATING TABLES parts
201.7.2.10 Applied parts
Amendment:
The APPLIED PART marking symbol according to Table D.1 (symbol 19, 20 or 21) shall be
located in a prominent place. Compliance is checked by inspection.
201.7.2.21 Mass of MOBILE OPERATING TABLES
This subclause of the general standard does not apply.
...