IEC 60601-1-8:2003

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Specifies requirements for alarm systems and alarm signals in medical electrical equipment and medical electrical systems. It also provides guidance for the application of alarm systems. The object of this collateral standard is to specify basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical 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.

Appareils électromédicaux - Partie 1-8: Règles générales de sécurité - Norme collatérale: Règles générales, essais et recommandations pour les systèmes d'alarme des appareils et des systèmes électromédicaux

Spécifie les exigences applicables aux systèmes d'alarme et aux signaux d'alarme des appareils et des systèmes électromédicaux. La présente norme collatérale a pour objet de spécifier les exigences de sécurité de base et les exigences en matière de performances essentielles ainsi que les essais des systèmes d'alarme des appareils et des systèmes électromédicaux et de donner des lignes directrices pour leur application. Cela est réalisé en définissant des catégories d'alarmes (priorités) par degré d'urgence, des signaux d'alarme et des états de commande cohérents et leur marquage pour tous les systèmes d'alarme.

General Information

• Status: Published
• Publication Date: 13-Aug-2003
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 2 - TC 62/SC 62A/JWG 2
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 25-Oct-2006

Relations

• Amended By: IEC 60601-1-8:2003/AMD1:2006 - Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-1-8:2006 - 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-1-8
First edition
2003-08
Medical electrical equipment –
Part 1-8:
General requirements for safety –
Collateral standard:
General requirements, tests and guidance
for alarm systems in medical electrical
equipment and medical electrical systems
Appareils électromédicaux –
Partie 1-8:
Règles générales de sécurité –
Norme collatérale:
Règles générales, essais et guides
pour les systèmes d'alarme dans l'équipement
électromédical et les systèmes électromédicaux

Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the

60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.

Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,

edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the

base publication incorporating amendment 1 and the base publication incorporating

amendments 1 and 2.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
this publication, including its validity, is available in the IEC Catalogue of
publications (see below) in addition to new editions, amendments and corrigenda.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is also available from the following:
• IEC Web Site (www.iec.ch)
• Catalogue of IEC publications
The on-line catalogue on the IEC web site (http://www.iec.ch/searchpub/cur_fut.htm)
enables you to search by a variety of criteria including text searches, technical
committees and date of publication. On-line information is also available on
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justpub/jp_entry.htm) is also available by email. Please contact the Customer
Service Centre (see below) for further information.
• Customer Service Centre
If you have any questions regarding this publication or need further assistance,
please contact the Customer Service Centre:
Email: [e-mail]
Tel: [phone]
Fax: [phone]
INTERNATIONAL IEC
STANDARD
60601-1-8
First edition
2003-08
Medical electrical equipment –
Part 1-8:
General requirements for safety –
Collateral standard:
General requirements, tests and guidance
for alarm systems in medical electrical
equipment and medical electrical systems
Appareils électromédicaux –
Partie 1-8:
Règles générales de sécurité –
Norme collatérale:
Règles générales, essais et guides
pour les systèmes d'alarme dans l'équipement
électromédical et les systèmes électromédicaux

 IEC 2003  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail]  Web: www.iec.ch
PRICE CODE
XB
For price, see current catalogue

– 2 – 60601-1-8  IEC:2003(E)
CONTENTS
FOREWORD . 4

INTRODUCTION .6

SECTION ONE – GENERAL
1 Scope and object . 7

1.201 Scope . 7

1.202 Object . 8

1.203 Relationship to other standards. 7
1.203.1 IEC 60601-1 . 7
1.203.2 Particular standards . 7
1.203.3 Normative references . 8
2 Terminology and definitions . 8
6 Identification, marking and documents .12
6.3 Marking of controls and instruments .12
6.7 Indicator lights and push-buttons.12
6.8.1 ACCOMPANYING DOCUMENTS .12
6.8.2 Instructions for use .12
6.8.3 Technical description.13
SECTION TWO TO TEN – NOT USED
201 ALARM SYSTEMS .13
201.1 ALARM CONDITION .13
201.1.1 General .13
201.1.2 ALARM CONDITION priority .13
201.2 Disclosures for INTELLIGENT ALARM SYSTEM.14
201.3 Generation of ALARM SIGNALS .14
201.3.1 General .14
201.3.2 Visual ALARM SIGNALS .14
201.3.3 Auditory ALARM SIGNALS .15
201.3.4 Characteristics of verbal ALARM SIGNALS .18
201.4 Disclosure of delays .18
201.4.1 ALARM SYSTEM delays .18

201.4.2 Delays to or from a DISTRIBUTED ALARM SYSTEM.19
201.5 ALARM PRESETS.19
201.5.1 General requirements .19
201.5.2 Manufacturer-configured ALARM PRESETS.20
201.5.3 USER- and OPERATOR-configured ALARM PRESETS.20
201.5.4 DEFAULT ALARM PRESET .21
201.5.5 Interruptions of less than or equal to 30 s .21
201.6 ALARM LIMIT.22
201.6.1 General requirements .22
201.6.2 Adjustable ALARM LIMIT .22
201.7 ALARM SYSTEM security .22
201.8 ALARM SIGNAL inactivation states .23
201.8.1 General .23
201.8.2 Termination of inactivation of ALARM SIGNALS.23

60601-1-8  IEC:2003(E) – 3 –
201.8.3 Indication and access .23

201.9 ALARM RESET .24

201.10 NON-LATCHING and LATCHING ALARM SIGNALS .24

201.11 DISTRIBUTED ALARM SYSTEM .25

201.11.1 Existence OF DISTRIBUTED ALARM SYSTEM .25

201.11.2 Requirements for DISTRIBUTED ALARM SYSTEM communication of

ALARM CONDITIONS .25

201.12 ALARM CONDITION logging.26

Appendix D (normative) Symbols on marking .27
Annex AAA (informative) Rationale and guidance.32
Annex BBB (informative) Cross-reference of identification, marking, and documents.61
Annex CCC (informative) Guidance for auditory ALARM SIGNALS.64
Annex DDD (informative) Verbal ALARM SIGNALS .65
Annex EEE (normative) Reserved melodies for ALARM SIGNALS.67
Bibliography.68
Index of defined terms.70
Figure 201 – Illustration of temporal characteristics of auditory ALARM SIGNALS.17
Figure AAA.1 – Graphical representation of components of ALARM SYSTEM delay.48
Table 201 – ALARM CONDITION priorities .13
Table 202 – Characteristics of alarm indicator lights .15
Table 203 – Characteristics of the BURST of auditory ALARM SIGNALS .16
Table 204 – Characteristics of the PULSE of auditory ALARM SIGNALS .16
Table 205 – ALARM SIGNAL inactivation states.24
Table D.201 – Graphical symbols for ALARM SYSTEMS .28
Table D.202 – Alternative ALARM SYSTEM related markings .31
Table AAA.1 – Reference interpretation of Table EEE.1 .60
Table AAA.2 – Reference interpretation of Table EEE.2 .60
Table BBB.1 – Cross-reference of Marking.61

Table BBB.2 – Cross-reference of ACCOMPANYING DOCUMENTS.62
Table BBB.3 – Cross-reference of instructions for use .63
Table BBB.4 – Cross-reference of technical description .63
Table CCC.1 – Attributes of perceived urgency .64
Table EEE.1 – Equipment encoded auditory ALARM SIGNALS categorized by ALARM
CONDITION and priority complying with Tables 203 and 204.67
Table EEE.2 – Auditory LOW PRIORITY ALARM SIGNAL complying with Tables 203 and 204.67

– 4 – 60601-1-8  IEC:2003(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-8: General requirements for safety –

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, 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
...

NORME CEI
INTERNATIONALE
IEC
60601-1-8
INTERNATIONAL
Première édition
STANDARD
First edition
2003-08
Appareils électromédicaux –
Partie 1-8:
Règles générales de sécurité – Norme collatérale:
Règles générales, essais et recommandations
pour les systèmes d'alarme des appareils et
des systèmes électromédicaux
Medical electrical equipment –
Part 1-8:
General requirements for safety – Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical electrical
equipment and medical electrical systems

Numéro de référence
Reference number
CEI/IEC 60601-1-8:2005
Numérotation des publications Publication numbering

Depuis le 1er janvier 1997, les publications de la CEI As from 1 January 1997 all IEC publications are

sont numérotées à partir de 60000. Ainsi, la CEI 34-1 issued with a designation in the 60000 series. For

devient la CEI 60034-1. example, IEC 34-1 is now referred to as IEC 60034-1.

Editions consolidées Consolidated editions

Les versions consolidées de certaines publications de la The IEC is now publishing consolidated versions of its

CEI incorporant les amendements sont disponibles. Par publications. For example, edition numbers 1.0, 1.1

exemple, les numéros d’édition 1.0, 1.1 et 1.2 indiquent and 1.2 refer, respectively, to the base publication,
respectivement la publication de base, la publication de the base publication incorporating amendment 1 and
base incorporant l’amendement 1, et la publication de the base publication incorporating amendments 1
base incorporant les amendements 1 et 2. and 2.
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NORME CEI
INTERNATIONALE
IEC
60601-1-8
INTERNATIONAL
Première édition
STANDARD
First edition
2003-08
Appareils électromédicaux –
Partie 1-8:
Règles générales de sécurité – Norme collatérale:
Règles générales, essais et recommandations
pour les systèmes d'alarme des appareils et
des systèmes électromédicaux
Medical electrical equipment –
Part 1-8:
General requirements for safety – Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical electrical
equipment and medical electrical systems

 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
XC
PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue

– 2 – 60601-1-8  CEI:2005
SOMMAIRE
AVANT-PROPOS.6

INTRODUCTION.10

SECTION UN – GÉNÉRALITÉS
1 * Domaine d’application et objet .12

1.201 Domaine d’application.12

1.202 Objet.12

1.203 Relations avec les autres normes .12
1.203.1 CEI 60601-1.12
1.203.2 Normes particulières .14
1.203.3 Références normatives .14
2 Terminologie et définitions.14
6 Identification, marquage et documentation.22
6.3 Marquage des commandes et des instruments .22
6.7 Voyants lumineux et boutons-poussoirs.22
6.8.1 DOCUMENTS D'ACCOMPAGNEMENT .24
6.8.2 Instructions d'utilisation .24
6.8.3 Description technique.24

SECTION DEUX – NON UTILISÉE
201 SYSTEMES D'ALARME.24
201.1 * CONDITION D'ALARME.24
201.1.1 * Généralités .24
201.1.2 * Priorité des CONDITIONS d'ALARME .26
201.2 * Présentation des indications pour les SYSTEMES D'ALARME INTELLIGENTS.26
201.3 Génération des SIGNAUX D'ALARME.28
201.3.1 Généralités.28
201.3.2 * SIGNAUX D'ALARME visuels .28
201.3.3 * SIGNAUX D'ALARME auditifs.30
201.3.4 * Caractéristiques des SIGNAUX D'ALARME vocaux .36
201.4 * Indication des délais .38
201.4.1 * Délais du SYSTEME D'ALARME.38

201.4.2 * Délais dans le cas d'un SYSTEME D'ALARME REPARTI .38
201.5 PRE-REGLAGES D'ALARME.38
201.5.1 Exigences générales .38
201.5.2 PRE-REGLAGES D'ALARME définis par le constructeur.40
201.5.3 * PRE-REGLAGES D'ALARME définis par l'UTILISATEUR et l'OPERATEUR.40
201.5.4 PRE-REGLAGE D'ALARME PAR DEFAUT .42
201.5.5 * Coupures inférieures ou égales à 30 s .44
201.6 LIMITE D'ALARME.44
201.6.1 Exigences générales .44
201.6.2  * LIMITE D'ALARME réglable .44
201.7 * Sécurité du SYSTEME D'ALARME.46
201.8 * Etats d'inactivation du SIGNAL D'ALARME .46
201.8.1 * Généralités .46
201.8.2 * Annulation de la désactivation des sIGNAUX D'ALARME .48

60601-1-8  IEC:2005 – 3 –
CONTENTS
FOREWORD.7

INTRODUCTION.11

SECTION ONE – GENERAL
1 * Scope and object .13

1.201 Scope .13

1.202 Object .13

1.203 Relationship to other standards.13

1.203.1 IEC 60601-1.13
1.203.2 Particular standards.15
1.203.3 Normative references.15
2 Terminology and definitions.15
6 Identification, marking and documents.23
6.3 Marking of controls and instruments.23
6.7 Indicator lights and push-buttons .23
6.8.1 ACCOMPANYING DOCUMENTS.25
6.8.2 Instructions for use.25
6.8.3 Technical description.25
SECTION TWO TO TEN – NOT USED
201 ALARM SYSTEMS.25
201.1 * ALARM CONDITION .25
201.1.1 * General .25
201.1.2 * ALARM CONDITION priority.27
201.2 * Disclosures for INTELLIGENT ALARM SYSTEM .27
201.3 Generation of ALARM SIGNALS.29
201.3.1 General .29
201.3.2 * Visual ALARM SIGNALS .29
201.3.3 * Auditory ALARM SIGNALS.31
201.3.4 * Characteristics of verbal ALARM SIGNALS.37
201.4 * Disclosure of delays .39
201.4.1 * ALARM SYSTEM delays.39
201.4.2 * Delays to or from a DISTRIBUTED ALARM SYSTEM .39

201.5 ALARM PRESETS .39
201.5.1 General requirements.39
201.5.2 Manufacturer-conf
...