SIST EN 60601-2-2:2009

SLOVENSKI STANDARD
SIST EN 60601-2-2:2009
01-julij-2009
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SIST EN 60601-2-2:2008
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Medical electrical equipment - Part 2-2: Particular requirements for basic safety and
essential performance of high frequency surgical equipment and high frequency surgical
accessories (IEC 60601-2-2:2009)
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
(IEC 60601-2-2:2009)
Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'électrochirurgie à courant haute
fréquence et des accessoires d'électrochirurgie à courant haute fréquence (CEI 60601-2-
2:2009)
Ta slovenski standard je istoveten z: EN 60601-2-2:2009
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN 60601-2-2:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-2:2009

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SIST EN 60601-2-2:2009

EUROPEAN STANDARD
EN 60601-2-2

NORME EUROPÉENNE
May 2009
EUROPÄISCHE NORM

ICS 11.040.30 Supersedes EN 60601-2-2:2007


English version


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 60601-2-2:2009)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-2: Exigences particulières Teil 2-2: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des appareils d'électrochirurgie von Hochfrequenz-Chirurgiegeräten
à courant haute fréquence und HF-chirurgischem Zubehör
et des accessoires d'électrochirurgie (IEC 60601-2-2:2009)
à courant haute fréquence
(CEI 60601-2-2:2009)


This European Standard was approved by CENELEC on 2009-04-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, 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.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels


© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-2:2009 E

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SIST EN 60601-2-2:2009
EN 60601-2-2:2009 - 2 -
Foreword
The text of document 62D/726/FDIS, future edition 5 of IEC 60601-2-2, 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 EN 60601-2-2 on 2009-04-01.
This European Standard supersedes EN 60601-2-2:2007.
Revisions in EN 60601-2-2:2009 include new language for preconditioning accessories prior to insulation
testing, refining the requirements for electromagnetic compatibility testing and correcting some of the
equations used in deriving the thermal test for NEUTRAL ELECTRODES.
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) 2010-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-04-01
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.
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 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.

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SIST EN 60601-2-2:2009
- 3 - EN 60601-2-2:2009
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.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-2:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-2-18 + A1 NOTE  Harmonized as EN 60601-2-18:1996 + A1:2000 (not modified).
__________

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SIST EN 60601-2-2:2009
EN 60601-2-2:2009 - 4 -
Annex ZA
(normative)

Normative references to international publications
with their corresponding 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 international 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 the references to IEC 60601-1-2 and IEC 60601-1-8 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
Standard: Electromagnetic compatibility -
Requirements and tests


IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems

Addition:
IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - EN 61000-4-3 2006
Part 4-3: Testing and measurement + IS1 2009
techniques - Radiated, radio-frequency,
electromagnetic field immunity test


1)
IEC 61000-4-6 2003 Electromagnetic compatibility (EMC) - EN 61000-4-6 2007
Part 4-6: Testing and measurement + corr. August 2007
techniques - Immunity to conducted + IS1 2009
disturbances, induced by radio-frequency
fields


2)
CISPR 11 (mod) 2003 Industrial scientific and medical (ISM) EN 55011 2007
radio-frequency equipment - Electromagnetic
disturbance characteristics - Limits and
methods of measurement



1)
 EN 61000-4-6:2007 includes A1:2004 + A2:2006 to IEC 61000-4-6:2003. It is superseded by EN 61000-4-6:2009, which is
based on IEC 61000-4-6:2008.
2)
 EN 55011:2007 includes A1:2004 (mod) to CISPR 11:2003 (mod).

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SIST EN 60601-2-2:2009
- 5 - EN 60601-2-2:2009
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
Commission 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 concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________

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SIST EN 60601-2-2:2009

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SIST EN 60601-2-2:2009
IEC 60601-2-2
®
Edition 5.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


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

Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.30 ISBN 2-8318-1029-9
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-2:2009
– 2 – 60601-2-2 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.7
201.1 Scope, object and related standards .8
201.2 Normative references .9
201.3 Terms and definitions.10
201.4 General requirements.13
201.5 General requirements for testing of ME EQUIPMENT.14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .14
201.7 ME EQUIPMENT identification, marking and documents.14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.19
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.33
201.10 Protection against unwanted and excessive radiation HAZARDS.33
201.11 Protection against excessive temperatures and other HAZARDS.34
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.35
201.13 HAZARDOUS SITUATIONS and fault conditions.41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .42
201.15 Construction of ME EQUIPMENT .42
201.16 ME SYSTEMs .46
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .46
202 * Electromagnetic compatibility – Requirements and tests .46
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems.47
Annexes .47
Annex AA (informative) Particular guidance and rationale.48
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT .70
Bibliography.79

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT.14
HF ISOLATED PATIENT CIRCUIT .15
Figure 201.102 – Symbol used with a
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 .20
Figure 201.104 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
referenced to earth and load between electrodes.23
Figure 201.105 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
referenced to earth and load from ACTIVE ELECTRODE to earth .24
Figure 201.106 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
isolated from earth at HIGH FREQUENCY.25
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ELECTRODE .26
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY.32
Figure 201.109 – Measurement of output power – MONOPOLAR output .37
Figure 201.110 – Measurement of output power – BIPOLAR output.38

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SIST EN 60601-2-2:2009
60601-2-2 © IEC:2009 – 3 –
Figure 201.111 – Method of testing feedback from one active output to another in
simultaneous activation.41
Figure AA.1 – Example of various parts of an HF surgical system.49
Figure AA.2 – CREST FACTOR vs. peak voltage .53
Figure AA.3 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth
at operating frequencies .57
Figure BB.1 – E-FIELD EMISSIONS test setup.73
Figure BB.2 – H-FIELD EMISSIONS test setup .74
Figure BB.3 – Conducted EMISSIONS test setup .75
Figure BB.4 – Unit ad hoc test .77
Figure BB.5 – Power cord ad hoc test.78
Figure BB.6 – ACCESSORY cord ad hoc test .78

Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL
EQUIPMENT .15
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS .40
Table 201.103 – Test currents by weight range.44
Table AA.1 – Summary of measured current and durations for 25 TUR procedures.65
Table AA.2 – Summary of measured currents and durations for general surgical
procedures .66
Table BB.1 – Worst case emissions of spark gap type HF SURGICAL EQUIPMENT .76
Table BB.2 – Worst case emissions of non-spark gap (modern) HF SURGICAL EQUIPMENT .76

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SIST EN 60601-2-2:2009
– 4 – 60601-2-2 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

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


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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 60601-2-2 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This fifth edition cancels and replaces the fourth edition published in 2006. This edition
constitutes a technical revision. Revisions in this edition include new language for
preconditioning accessories prior to insulation testing, refining the requirements for
electromagnetic compatibility testing and correcting some of the equations used in deriving
the thermal test for NEUTRAL ELECTRODES.

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SIST EN 60601-2-2:2009
60601-2-2 © IEC:2009 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/726/FDIS 62D/755/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:
– 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 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.

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SIST EN 60601-2-2:2009
– 6 – 60601-2-2 © IEC:2009
The committee has decided that the contents of this particular standard will remain
unchanged until the maintenance result 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

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SIST EN 60601-2-2:2009
60601-2-2 © IEC:2009 – 7 –
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of high frequency surgical equipment.
This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical
electrical equipment – Part 1: General requirements for basic safety and essential
performance, hereinafter referred to as the general standard (see 201.1.4).
The requirements are followed by specifications for the relevant tests.
A "Particular guidance and rationale" section giving some explanatory notes, where
appropriate, about the more important requirements is included in annex AA.
Clauses or subclauses for which there are explanatory notes in annex AA are marked with an
asterisk (*).
It is considered that a 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 neces-
sitated 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 60601-2-2:2009
– 8 – 60601-2-2 © IEC:2009
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



201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
This International Standard applies to the
SURGICAL EQUIPMENT as defined in 201.3.222.
HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for
micro-COAGULATION, or for use in dentistry or ophthalmology) is exempt from certain of the
requirements of this particular standard. These exemptions are indicated in the relevant
requirements.
201.1.2 Object
Replacement:
BASIC SAFETY and ESSENTIAL
The object of this particular standard is to establish particular
PERFORMANCE requirements for HF SURGICAL EQUIPMENT as defined in 201.3.222.
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 2 of this particular standard.
IEC 60601-1-2 and IEC 60601-1-8 apply as modified in Clauses 202 and 208 respectively.
2)
IEC 60601-1-3, IEC 60601-1-10 and IEC 60601-1-11 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
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
2)
IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment (in preparation).

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SIST EN 60601-2-2:2009
60601-2-2 © IEC:2009 – 9 –
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 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 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 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 complete
...