SIST EN 60601-1-8:2008

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

Medicinska električna oprema - 1-8. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Splošne zahteve, preskušanje in napotki za alarmne sisteme v medicinski električni opremi in medicinskih električnih sistemih (IEC 60601-1-8:2006)

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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SLOVENSKI STANDARD
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
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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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 by a revised edition, or
• amended
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INTRODUCTION
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS are increasingly used in
medical practice. ALARM SIGNALS are frequently used to indicate unsatisfactory physiological
PATIENT states, unsatisfactory functional states of the MEDICAL ELECTRICAL EQUIPMENT or
MEDICAL ELECTRICAL SYSTEM or to warn the OPERATOR of HAZARDS to the PATIENT or OPERATOR
due to the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM. INFORMATION
SIGNALS convey information that is independent of an ALARM CONDITION.
Surveys of healthcare personnel have indicated significant discontent with ALARM SIGNALS.
Problems include difficulty in identifying the source of an ALARM SIGNAL, loud and distracting
ALARM SIGNALS, and the high incidence of FALSE POSITIVE or NEGATIVE ALARM

1)
CONDITIONS [16] . Surveys of MANUFACTURERS of medical monitors demonstrated a wide
variety of DEFAULT ALARM PRESETS. The leading reason for disabling ALARM SIGNALS is the large
number of ALARM SIGNALS associated with FALSE POSITIVE ALARM CONDITIONS. See also
bibliography.
Safety of PATIENTS depends on the ability of the OPERATOR to correctly discern the
characteristics of ALARM SIGNALS. USABILITY is an important element in the design of ALARM
SIGNALS that are readily discernible without being unnecessarily distracting or disturbing. This
approach is intended to rationalize the current situation, to reduce confusion by limiting
proliferation of ALARM SIGNALS and their control states, and to minimize distraction for other
people. This collateral standard was developed with contributions from clinicians, engineers
and applied psychologists.
The terminology, requirements, general recommendations and guidance of this collateral
standard are intended to be useful for MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT and
MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for particular
standards.
The effectiveness of any ALARM SYSTEM depends critically on its implementation by the
RESPONSIBLE ORGANIZATION. It is important that the RESPONSIBLE ORGANIZATION configure the
ALARM SYSTEM so that an OPERATOR is not able to compromise it.
—————————
1) Figures in brackets refer to the bibliography.

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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

1 * Scope, object and related standards
1.1 Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in
ME EQUIPMENT and ME SYSTEMS.
It also provides guidance for the application of ALARM SYSTEMS.
1.2 Object
The object of this collateral standard is to specify basic safety and essential performance
requirements and tests for ALARM SYSTEMS in ME EQUIPMENT and ME SYSTEMS and to provide
guidance for their application. This is accomplished by defining alarm categories (priorities) by
degree of urgency, consistent ALARM SIGNALS and consistent control states and their marking
for all ALARM SYSTEMS.
This collateral standard does not specify:
– whether any particular ME EQUIPMENT or ME SYSTEM is required to be provided with ALARM
SYSTEMS;
– the particular circumstances which initiate an ALARM CONDITION;
– the allocation of priorities to a particular ALARM CONDITION; or
– the means of generating ALARM SIGNALS.
1.3 Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1.
When referring to IEC 60601-1 or to this collateral standard, either individually or in
combination, the following conventions are used:
– "the general standard" designates IEC 60601-1 alone;
– "this collateral standard" designates IEC 60601-1-8 alone;
– "this standard" designates the combination of the general standard and this collateral
standard.
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1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.
2 Normative references
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.
IEC 60417, Graphical symbols for use on equipment
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
2)
IEC 60601-1-2:---- , Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic compatibility –
Requirements and tests
3)
IEC 60601-1-6:---- , Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability

4)
IEC 60651:1979 , Sound level meters
Amendment 1 (1993)
Amendment 2 (2000)
ISO 3744:1994, Acoustics – Determination of sound power 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
5) 6)
IEC 60601-1-2:---- , IEC 60601-1-6:---- , and the following definitions apply.
NOTE 1 The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. This
standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in
the context of an ME SYSTEM.
NOTE 2 An index of defined terms is found beginning on page 155.
—————————
2)
A second edition of IEC 60601-1-2 exists, published in 2004 under the title Medical electrical equipment – Part
1-2: General requirements for safety – Collateral Standard: Electromagnetic compatibility – Requirements and
tests. A third edition under the title given above is currently to be published. References to IEC 60601-1-2 in

this standard refer to the new edition.
3)
A first edition of IEC 60601-1-6 exists, published in 2004 under the title Medical electrical equipment – Part 1-6:
General requirements for safety – Collateral Standard: Usability. A second edition under the title given above is
currently to be published. References to IEC 60601-1-6 in this standard refer to the new edition.
4)
IEC 60651:1979 has been withdrawn and replaced by IEC 61672-1:2002 and IEC 61672-2:2003. Future editions
of this publication will be amended to take this fact into account.
5)
To be published. See footnote 2.
6)
To be published. See footnote 3.

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3.1
* ALARM CONDITION
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARD exists
NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSTIVE ALARM CONDITION.
NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.
3.2
* ALARM CONDITION DELAY
time from the occurrence of a triggering event either in the PATIENT, for PHYSIOLOGICAL ALARM
CONDITIONS, or in the equipment, for TECHNICAL ALARM CONDITIONS, to when the ALARM SYSTEM
determines that an ALARM CONDITION exists
3.3
ALARM LIMIT
*
threshold used by an ALARM SYSTEM to determine an ALARM CONDITION
3.4
ALARM OFF
state of indefinite duration in which an ALARM SYSTEM or part of an ALARM SYSTEM does not
generate ALARM SIGNALS
3.5
* ALARM PAUSED
state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not
generate ALARM SIGNALS
3.6
ALARM PRESET
set of stored configuration parameters, including selection of algorithms and initial values for
use by algorithms, which affect or modify the performance of the ALARM SYSTEM
3.7
ALARM RESET
OPERATOR action that causes the cessation of an ALARM SIGNAL for which no associated ALARM
CONDITION currently exists
3.8
ALARM SETTINGS
ALARM SYSTEM configuration, including but not limited to:
– ALARM LIMITS;
– the characteristics of any ALARM SIGNAL inactivation states; and
– the values of variables or parameters that determine the function of the ALARM SYSTEM
NOTE Some algorithmically-determined ALARM SETTINGS can require time to be determined or re-determined.
3.9
ALARM SIGNAL
type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an
ALARM CONDITION
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3.10
* ALARM SIGNAL GENERATION DELAY
time from the onset of an ALARM CONDITION to the generation of its ALARM SIGNAL(S)
3.11
ALARM SYSTEM
parts of ME EQUIPMENT or a ME SYSTEM that detect ALARM CONDITIONS and, as appropriate,
generate ALARM SIGNALS
3.12
AUDIO OFF
state of indefinite duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not
generate an auditory ALARM SIGNAL
3.13
AUDIO PAUSED
state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not
generate an auditory ALARM SIGNAL
3.14
BURST
group of PULSES with a distinctive rhythm or pattern
3.15
DE-ESCALATION
PROCESS by which an ALARM SYSTEM decreases the priority of an ALARM CONDITION or
decreases the sense of urgency of an ALARM SIGNAL
3.16
DEFAULT ALARM PRESET
ALARM PRESET that can be activated by the ALARM SYSTEM without OPERATOR action
NOTE MANUFACTURER- or RESPONSIBLE ORGANIZATION-configured ALARM PRESETS are possible types of DEFAULT
ALARM PRESETS.
3.17
* DISTRIBUTED ALARM SYSTEM
ALARM SYSTEM that involves more than one item of equipment of a ME SYSTEM
NOTE The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.
3.18
ESCALATION
PROCESS by which an ALARM SYSTEM increases the priority of an ALARM CONDITION or increases
the sense of urgency of an ALARM SIGNAL
3.19
FALL TIME
t
f
interval over which the PULSE amplitude decreases from 90 % to 10 % of its maximum (see
Figure 1)
3.20
FALSE NEGATIVE ALARM CONDITION
absence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the
equipment or the ALARM SYSTEM
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NOTE An ALARM CONDITION can be rejected or missed because of spurious information produced by the PATIENT,
the PATIENT-equipment interface, other equipment or the equipment itself.
3.21
FALSE POSITIVE ALARM CONDITION
presence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT,
the equipment or the ALARM SYSTEM
NOTE A FALSE POSITIVE ALARM CONDITION can be caused by spurious information produced by the PATIENT, the
PATIENT-equipment interface, other equipment or the ALARM SYSTEM itself.
3.22
HIGH PRIORITY
indicating that immediate OPERATOR response is required
NOTE The priority is assigned through RISK ANALYSIS.
3.23
* INFORMATION SIGNAL
any signal that is not an ALARM SIGNAL or a REMINDER SIGNAL
EXAMPLE 1 ECG waveform
EXAMPLE 2 SpO tone
EXAMPLE 3 Fluoroscopy beam-on indication
3.24
* INTELLIGENT ALARM SYSTEM
ALARM SYSTEM that makes logical decisions based on monitored information without OPERATOR
intervention
EXAMPLE 1 An ALARM SYSTEM that changes priority based on the rate of change of a monitored variable.
EXAMPLE 2 An ALARM SYSTEM that suppresses an ALARM CONDITION when a related ALARM CONDITION of higher
priority has recently generated an ALARM SIGNAL.
3.25
INTERBURST INTERVAL
t
b
period of time between the end of the last PULSE of a BURST and the start of the first PULSE of
the next BURST of the same ALARM SIGNAL (see Figure 1)
3.26
LATCHING ALARM SIGNAL
ALARM SIGNAL that continues to be generated after its triggering event no longer exists until
stopped by deliberate OPERATOR action
3.27
LOW PRIORITY
indicating that OPERATOR awareness is required
NOTE The priority is assigned through RISK ANALYSIS.
3.28
MEDIUM PRIORITY
indicating that prompt OPERATOR response is required
NOTE The priority is assigned through RISK ANALYSIS.
3.29
NON-LATCHING ALARM SIGNAL
ALARM SIGNAL that automatically stops being generated when its associated triggering event
no longer exists
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3.30
OPERATOR'S POSITION
intended position of the OPERATOR with respect to the ALARM SIGNAL generating part of the
ALARM SYSTEM
NOTE A DISTRIBUTED ALARM SYSTEM can have multiple OPERATOR’S POSITIONS.
3.31
PHYSIOLOGICAL ALARM CONDITION
ALARM CONDI
...