SIST EN 60601-1-8:2008

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SLOVENSKI STANDARD
SIST EN 60601-1-8:2008
01-januar-2008
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Medical electrical equipment - 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 (IEC
60601-1-8:2006)
Medizinische elektrische Gerte - Teil 1-8: Allgemeine Festlegungen fr die Sicherheit
einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Alarmsysteme -
Allgemeine Festlegungen, Prfungen und Richtlinien fr Alarmsysteme in medizinischen
elektrischen Gerten und in medizinischen elektrischen Systemen (IEC 60601-1-8:2006)
Appareils lectromdicaux - Partie 1-8: Exigences gnrales pour la scurit de base et les
performances essentielles - Norme collatrale: Exigences gnrales, essais et guide pour
les systmes d'alarme des appareils et des systmes lectromdicaux (IEC 60601-1-8:2006)
Ta slovenski standard je istoveten z: EN 60601-1-8:2007
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-8:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN 60601-1-8

NORME EUROPÉENNE
July 2007
EUROPÄISCHE NORM

ICS 11.040.01 Supersedes EN 60601-1-8:2004 + A1:2006

English version

Medical electrical equipment -
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
(IEC 60601-1-8:2006)

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-8: Exigences générales Teil 1-8: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Exigences générales, Ergänzungsnorm: Alarmsysteme -
essais et guide pour les systèmes Allgemeine Festlegungen, Prüfungen
d'alarme des appareils und Richtlinien für Alarmsysteme
et des systèmes électromédicaux in medizinischen elektrischen Geräten
(CEI 60601-1-8:2006) und in medizinischen elektrischen
Systemen
(IEC 60601-1-8:2006)

This European Standard was approved by CENELEC on 2007-04-11. 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: rue de Stassart 35, B - 1050 Brussels


© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-8:2007 E

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EN 60601-1-8:2007 - 2 -
Foreword
The text of document 62A/519/CDV, future edition 2 of IEC 60601-1-8, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in
medical practice, and ISO SC 3, Lung ventilators and related devices, of ISO TC 121, Anaesthetic and
respiratory equipment, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure
and was approved by CENELEC as EN 60601-1-8 on 2007-04-11.
The following date was 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) 2008-02-01
This European Standard supersedes EN 60601-1-8:2004 and its amendment A1:2006
(+ corrigendum October 2006). However, EN 60601-1-8:2004 remains valid until all the parts 2 that
are used in conjunction with it have been withdrawn. No date of withdrawal of conflicting national
standards (dow) has therefore been fixed. However, when Part 1-8 is used for appliances not covered
by a part 2, EN 60601-1-8:2004 is not to be used after 2009-09-12.
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 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
This EN 60601-1-8 was revised to structurally align it with EN 60601-1:2006 and to implement the
decision of IEC SC 62A that the clause numbering structure of collateral standards written to
EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle
technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk
management process in EN 60601-1:2006.
In the 60601 series of publications, collateral standards specify general requirements for safety
applicable to
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general
standard (e.g. alarm systems).
In this collateral standard the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in italic type. In addition, in Annex A text in italics indicates guidance that
describes means to achieve the safety objectives of this collateral standard;
− 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 COLLATERAL STANDARD OR AS NOTES:
IN SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the six numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses
of Clause 6).

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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.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are
marked with an asterisk (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-8:2006 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:
ISO/IEC 14971 NOTE Harmonized as EN ISO 14971:2000 (not modified).
__________

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EN 60601-1-8:2007 - 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.

Publication Year Title EN/HD Year
IEC 60417 Data Graphical symbols for use on equipment - -
base


IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
safety and essential performance


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 60601-1-6 2006 Medical electrical equipment - EN 60601-1-6 2007
Part 1-6: General requirements for basic
safety and essential performance -
Collateral standard: Usability


1)
IEC 60651 1979 Sound level meters EN 60651 1994
A1 1993 A1 1994

A2 2000 A2 2001


ISO 3744 1994 Acoustics - Determination of sound power EN ISO 3744 1995
levels of noise sources using sound
pressure - Engineering method in an
essentially free field over a reflecting plane


ISO 7000 1989 Graphical symbols for use on equipment - - -
Index and synopsis




1)
EN 60651 + A1 + A2 are superseded by EN 61672-1:2003 & EN 61672-2:2003, which are based on
IEC 61672-1:2002 & IEC 61672-2:2003.

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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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IEC 60601-1-8
Edition 2.0 2006-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
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

Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences générales, essais et guide pour
les systèmes d’alarme des appareils et des systèmes électromédicaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.01 ISBN 2-8318-8826-3

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60601-1-8 © IEC:2006 –– 2 – 3 – 60601-1-8 © IEC:2006
CONTENTS
FOREWORD.4
INTRODUCTION.7

1 * Scope, object and related standards .8
1.1 Scope.8
1.2 Object .8
1.3 Related standards .8
2 Normative references .9
3 Terms and definitions .9
4 General requirements .13
5 ME EQUIPMENT identification marking and documents.14
5.1 Indicator lights and controls.14
5.2 ACCOMPANYING DOCUMENTS.14
6 ALARM SYSTEMS.14
6.1 ALARM CONDITION .14
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM .15
6.3 Generation of ALARM SIGNALS .16
6.4 * Disclosure of delays.21
6.5 ALARM PRESETS.21
6.6 ALARM LIMIT .24
6.7 * ALARM SYSTEM security.25
6.8 * ALARM SIGNAL inactivation states .25
6.9 * ALARM RESET .27
6.10 * NON-LATCHING and LATCHING ALARM SIGNALS .27
6.11 * DISTRIBUTED ALARM SYSTEM .28
6.12 * ALARM CONDITION logging .29

Annex A (informative) General guidance and rationale.30
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.64
Annex C (normative) Symbols on marking.67
ANNEX D (informative) Guidance for auditory ALARM SIGNALS .71
ANNEX E (informative) Verbal ALARM SIGNALS.72
ANNEX F (normative) * Reserved melodies for ALARM SIGNALS.75

Bibliography.76

Index of defined terms used in this collateral standard.78

Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS .19
Figure A.1 – Graphical representation of components of ALARM SYSTEM delay .49

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Table 1 – ALARM CONDITION priorities.15
Table 2 – Characteristics of alarm indicator lights .16
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS .18
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS.18
Table 5 – ALARM SIGNAL inactivation states.27
Table A.1 – Reference interpretation of Table F.1.62
Table A.2 – Reference interpretation of Table F.2.63
Table B.1 – Cross-reference of marking.64
Table B.2 – Cross-reference of ACCOMPANYING DOCUMENTS .65
Table B.3 – Cross-reference of instructions for use.65
Table B.4 – Cross-reference of technical description .66
Table C.1 – Graphical symbols for ALARM SYSTEMS .67
Table C.2 – Alternative ALARM SYSTEM related markings.70
Table D.1 – Attributes of perceived urgency.71
Table F.1 – * Equipment encoded auditory ALARM SIGNALS categorized by ALARM
CONDITION and priority complying with Table 3 and Table 4 .75
Table F.2 – * Auditory LOW PRIORITY ALARM SIGNAL complying with Table 3 and Table 4 .75

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

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


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 60601-1-8 has been prepared by IEC subcommittee 62A: Common
aspects of electrical equipment used in medical practice of IEC technical committee 62:
Electrical equipment in medical practice, and ISO subcommittee SC 3: Lung ventilators and
related devices of ISO technical committee 121: Anaesthetic and respiratory equipment.
It is published as double logo standard.
IEC 60601-1-8 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment
– Part 1: General requirements for safety and essential performance hereafter referred to as
the general standard.

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60601-1-8 © IEC:200660601-1-8 © IEC:2006 –– 5 – 9 –
This second edition cancels and replaces the first edition of IEC 60601-1-8, published in
2003, of which it constitutes a technical revision.
This edition of IEC 60601-1-8 was revised to structurally align it with the 2005 edition of IEC
60601-1 and to implement the decision of IEC Subcommittee 62 A that the clause numbering
structure of collateral standards written to IEC 60601-1:2005 would adhere to the form
specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4,
which now recognizes that there is a general requirement for a risk management process in
IEC 60601-1:2005.
The text of this collateral standard is based on the following documents:
CDV Report on voting
62A/519/CDV 62A/537A/RVC

Full information on the voting for the approval of this collateral standard can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved by
18 P-members out of 18 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In the 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. ALARM SYSTEMS).
In this collateral standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type. In addition, in Annex A text in italics indicates guidance that
describes means to achieve the safety objectives of this collateral standard.
– 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 COLLATERAL 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 6 includes Subclauses 6.1, 6.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.3.1 are all
subclauses of Clause 6).
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.

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60601-1-8 © IEC:2006 –– 6 – 11 – 60601-1-8 © IEC:2006
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.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A
are marked with an asterisk (*).
A list of all parts of the IEC 60601 series, under the general title: Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this collateral 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 b
...