SIST EN 60601-2-62:2015

SLOVENSKI STANDARD
SIST EN 60601-2-62:2015
01-september-2015
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ELVWYHQHODVWQRVWLYLVRNRLQWHQ]LYQLKWHUDSHYWVNLKXOWUD]YRþQLK+,78QDSUDY
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and
essential performance of high intensity therapeutic ultrasound (HITU) equipment
Medizinische elektrische Geräte - Teil 2-62: Besondere Anforderungen an die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von hochintensiven therapeutischen
Ultraschallsystemen (HITU-Systemen)
Appareils électromédicaux - Partie 2-62: Exigences particulières pour la sécurité de base
et les performances essentielles des systèmes à ultrasons thérapeutiques de haute
intensité (HITU)
Ta slovenski standard je istoveten z: EN 60601-2-62:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-62:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-62:2015

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SIST EN 60601-2-62:2015


EUROPEAN STANDARD EN 60601-2-62

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.01; 17.140.50

English Version
Medical electrical equipment - Part 2-62: Particular requirements
for the basic safety and essential performance of high intensity
therapeutic ultrasound (HITU) equipment
(IEC 60601-2-62:2013)
Appareils électromédicaux - Partie 2-62: Exigences Medizinische elektrische Geräte - Teil 2-62: Besondere
particulières pour la sécurité de base et les performances Anforderungen an die Sicherheit einschließlich der
essentielles des appareils ultrasonores thérapeutiques de wesentlichen Leistungsmerkmale von hochintensiven
haute intensité (HITU) therapeutischen Ultraschallsystemen (HITU-Systemen)
(IEC 60601-2-62:2013) (IEC 60601-2-62:2013)
This European Standard was approved by CENELEC on 2015-04-14. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-62:2015 E

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SIST EN 60601-2-62:2015
EN 60601-2-62:2015
Foreword
The text of document 62D/1069/FDIS, future IEC 60601-2-62, 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 60601-2-62:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
standards conflicting with the
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.

Endorsement notice
The text of the International Standard IEC 60601-2-62:2013 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 60601-2-5 NOTE Harmonized as EN 60601-2-5.
IEC 60601-2-36 NOTE Harmonized as EN 60601-2-36.
IEC 60529 NOTE Harmonized as EN 60529.
IEC 61161 NOTE Harmonized as EN 61161.
IEC 61828 NOTE Harmonized as EN 61828.
IEC 62464-1 NOTE Harmonized as EN 62464-1.
IEC 62555 NOTE Harmonized as EN 62555.
2

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SIST EN 60601-2-62:2015
EN 60601-2-62:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When 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

Annex ZA of EN 60601-1:2006 applies except as follows:

Publication Year Title EN/HD Year
Replacement:
1)
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
1)
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
Addition:
IEC 61689 2013 Ultrasonics - Physiotherapy systems - EN 61689 2013
Field specifications and methods of
measurement in the frequency range
0,5 MHz to 5 MHz
IEC/TS 61949 -  Ultrasonics - Field characterization - CLC/TS 61949 -
In situ exposure estimation in finite-
amplitude ultrasonic beams
IEC 62127-1 -  Ultrasonics - Hydrophones - EN 62127-1 -
Part 1: Measurement and characterization
of medical ultrasonic fields up to 40 MHz
IEC 62127-2 -  Ultrasonics - Hydrophones - EN 62127-2 -
Part 2: Calibration for ultrasonic fields
up to 40 MHz
IEC 62359 -  Ultrasonics - Field characterization - Test EN 62359 -
methods for the determination of thermal
and mechanical indices related to medical
diagnostic ultrasonic fields
IEC 62555 -  Ultrasonics - Power measurement - High EN 62555 -
intensity therapeutic ultrasound (HITU)
transducers and systems
IEC/TS 62556 -  Ultrasonics - Field characterization - - -
Specification and measurement of field
parameters for high intensity therapeutic
ultrasound (HITU) transducers and
systems


1)
Superseded by EN 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2018-12-31.
3

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SIST EN 60601-2-62:2015
EN 60601-2-62:2015
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
4

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SIST EN 60601-2-62:2015




IEC 60601-2-62

®


Edition 1.0 2013-07




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Medical electrical equipment –

Part 2-62: Particular requirements for the basic safety and essential performance

of high intensity therapeutic ultrasound (HITU) equipment




Appareils électromédicaux –

Partie 2-62: Exigences particulières pour la sécurité de base et les performances


essentielles des appareils ultrasonores thérapeutiques de haute intensité (HITU)













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX XB


ICS 11.040.01; 17.140.50 ISBN 978-2-8322-0865-6



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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SIST EN 60601-2-62:2015
– 2 – 60601-2-62 © IEC:2013
CONTENTS
FOREWORD . 4
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 . 21
201.5 General requirements for testing of ME EQUIPMENT . 22
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 23
201.7 ME EQUIPMENT identification, marking and documents . 23
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 25
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 25
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 28
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 30
201.14 Programmable ELECTRICAL MEDICAL SYSTEMS (PEMS). 30
201.15 Construction of ME EQUIPMENT . 30
201.16 ME systems . 30
201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30
202 Electromagnetic compatibility – Requirements and tests . 30
Annexes . 33
Annex AA (informative) Particular guidance and rationale . 34
Annex BB (informative) Targeting . 38
Annex CC (informative) HITU – specific risks . 41
Annex DD (informative) Determining regions of HITU fields for measurement . 46
Annex EE (informative) Guidance in classification according to CISPR 11 . 57
Annex FF (informative) Notes on using a saline or water bath for EMI testing . 58
Bibliography . 61

Figure 201.101 – Schematic diagram showing the relationship between the various
defined surfaces and distances for an ULTRASONIC TRANSDUCER with water stand-off
distance when applied to a PATIENT. [IEC 61157 Ed2] . 20
Figure 201.102 – Parameters for describing a focusing transducer of a known
geometry . 20
Figure 201.103 – Example set-up for the measurement of the unwanted ultrasound
radiation on the side-wall (the handle) of the transducer . 27
Figure DD.1 – Illustration of target, intermediate (shaded or yellow) region and safe
regions defined by boundaries 1 and 2. . 46
Figure DD.2 – Exposure time vs temperature increase above 37 °C for three different
bioffects threshold exposures shown as solid curves. . 47
Figure DD.3 – Two-layer model with target . 51
Figure DD.4 – TEMPORAL-AVERAGE INTENSITY (in dB) corrected for absorption vs
transverse dimension in the focal plane . 54

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SIST EN 60601-2-62:2015
60601-2-62 © IEC:2013 – 3 –
Figure DD.5 – TEMPORAL-AVERAGE INTENSITY (in dB) vs axial distance z (mm) for a
beam from a spherical focusing transducer with a radius of 20 mm and a geometric
focal length of 40 mm at 1 MHz . 55
Figure DD.6 – Overlapping multiple exposure regions in a target region depicted by the
dark ellipse . 56
Figure FF.1 – Representing the patient or operator impedance. . 58
Figure FF.2 – Possible setup for artificial hand for HITU equipment. . 59
Figure FF.3 – Showing copper band in saline. . 60

Table 201.101 – List of symbols & abbreviations. 21
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements . 22
Table CC.1 – Hazards related to image to focus misalignment . 41
Table CC.2 – Hazards related to use of HITU device by unskilled or untrained
personnel or reasonably foreseeable misuse . 41
Table CC.3 – Hazards arising from improper acoustic energy . 42
Table CC.4 – Lack of, or inadequate, specification for maintenance including
inadequate specification of post-maintenance functional checks . 43
Table CC.5 – Miscellaneous hazards . 43
Table CC.6 – Data transfer errors . 43
Table CC.7 – HITU transducer failure . 44
Table CC.8 – Generator failure . 44
Table CC.9 – Cooling system failure . 44
Table CC.10 – Software gets stuck in endless loop . 44
Table CC.11 – Wrong calculations by computer . 45

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SIST EN 60601-2-62:2015
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-62: Particular requirements for the basic safety and essential
performance of high intensity therapeutic ultrasound (HITU) equipment

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 OPERATOR.
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 60601-2-62 has been prepared by IEC subcommittee 62D:
[Therapy equipment] Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice. It has been prepared in close co-operation with TC 87
(Ultrasonics).
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1069/FDIS 62D/1076/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:

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SIST EN 60601-2-62:2015
60601-2-62 © IEC:2013 – 5 –
– 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 seventeen 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 web site 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.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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SIST EN 60601-2-62:2015
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INTRODUCTION
In this particular standard, safety requirements additional to those in the general standard are
specified for HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT.
This particular standard takes into account IEC 62555 and IEC/TS 62556.
The requirements are followed by specifications for the relevant tests.
A rationale for the more important requirements, where appropriate, is given in Annex AA. It is
considered that knowledge of the reasons for these requirements will not only facilitate the
proper application of the particular standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However this annex does not form part of the requirements of this standard.

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SIST EN 60601-2-62:2015
60601-2-62 © IEC:2013 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-62: Particular requirements for the basic safety and essential
performance of high intensity therapeutic ultrasound (HITU) equipment



201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Addition:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH
INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT as defined in 201.3.218, hereafter referred to as
ME EQUIPMENT.
This International Standard adds or replaces clauses listed in the IEC 60601-1 that are
specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard.
NOTE 2 As, in HITU fields, the acoustic waveform is expected to be extremely distorted due to non-linear
propagation effects, the ultrasonic measurements are to be made under quasi linear conditions and then
extrapolated following procedures given in IEC/TS 62556. See also IEC/TS 61949
This standard can also be applied to:
– therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic
ultrasound;
– therapeutic equipment for the treatment of occluding feeding vessels through exposure to
high-intensity focused ultrasound;
– equipment intended to be used for relieving cancer pain due to bone metastases.
This particular standard does not apply to:
2)
• ULTRASOUND EQUIPMENT intended to be used for physiotherapy (use: IEC 60601-2-5 [1]
and IEC 61689);
• ULTRASOUND EQUIPMENT intended to be used for lithotripsy (use: IEC 60601-2-36 [2]);
• ULTRASOUND EQUIPMENT intended to be used for dedicated hyperthermia devices;
• ULTRASOUND EQUIPMENT intended to be used for phacoemulsification.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
2)
Numbers in square brackets refer to the Bibibliography.

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SIST EN 60601-2-62:2015
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201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT [as
defined in 201.3.218.]
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.
IEC 60601-1-2:2007 applies as modified in Clause 202. 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 particular standard addresses the
content of Clause 1 of the general standard) or applicable collateral standard with the prefix
“20x” where x 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
...