EN 60601-1-8:2004
(Main)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
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
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.
Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen elektrischen Geräten und in medizinischen elektrischen Systemen
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
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.
Medicinska električna oprema – 1-8. del: Splošne varnostne zahteve – Spremljevalni standard: Splošne zahteve, preskusi in napotki za alarmne sisteme v medicinski električni opremi in medicinskih električnih sistemih
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EUROPEAN STANDARD EN 60601-1-8
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2004
ICS 11.040.01
English version
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 60601-1-8:2003)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 1-8: Règles générales de sécurité - Teil 1-8: Allgemeine Festlegungen
Norme collatérale: Règles générales, für die Sicherheit -
essais et guides pour les systèmes Ergänzungsnorm: Alarmsysteme -
d'alarme dans l'équipement Allgemeine Festlegungen, Prüfungen
électromédical et les systèmes und Richtlinien für Alarmsysteme
électromédicaux in medizinischen elektrischen Geräten
(CEI 60601-1-8:2003) und in medizinischen Systemen
(IEC 60601-1-8:2003)
This European Standard was approved by CENELEC on 2003-12-02. 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, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and 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
© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-8:2004 E
Foreword
The text of document 62A/424/FDIS, future edition 1 of IEC 60601-1-8, prepared by a Joint Working
Group of SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62,
Electrical equipment in medical practice, and SC3, Lung ventilators and related devices, of ISO
TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and
was approved by CENELEC as EN 60601-1-8 on 2003-12-02.
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) 2004-09-01
– latest date by which the national standards conflicting
(dow) 2006-12-01
with the EN have to be withdrawn
This European Standard is a collateral standard to EN 60601-1:1990, hereinafter referred to as the
general standard.
In the 60601 series of publications, collateral standards specify general requirements for safety
applicable to
– a group 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).
The numbering of sections, clauses and subclauses of this collateral standard corresponds with that of
the general standard.
Clauses, subclauses, tables and figures which are additional to those of the general standard are
numbered starting from 201; additional annexes are lettered AAA, BBB, etc., and additional items
aaa), bbb), etc.
In this collateral standard, the following print types are used:
– requirements and definitions: roman type;
– notes, examples, explanations, advice, introductions, general statements and references: smaller roman type;
– test specifications and guidance in Annex AAA: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED:
SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests.
Clauses and subclauses for which a rationale is provided in the informative Annex AAA are marked
with an asterisk (*).
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-8:2003 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 14971 NOTE Harmonized as EN ISO 14971:2000 (not modified).
__________
- 3 - EN 60601-1-8:2004
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 database Graphical symbols for use on equipment - -
IEC 60601-1 1988 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1991 A1 1993
+ corr. July 1994
A2 1995 A2 1995
+ corr. June 1995
A13 1996
IEC 60601-1-1 2000 Medical electrical equipment EN 60601-1-1 2001
Part 1-1: General requirements for
safety - Collateral standard: Safety
requirements for medical electrical
systems
1)
IEC 60601-1-6 - Part 1-6: General requirements for - -
safety - Collateral standard: Usability
IEC 60651 1979 Sound level meters EN 60651 1994
A1 1993 A1 1994
A2 2000 A2 2001
ISO 3744 1994 Acoustics - Determination of sound EN ISO 3744 1999
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
1)
To be published.
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: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
XC
PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue
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-configured ALARM PRESETS .41
201.5.3 * USER- and OPERATOR-configured ALARM PRESETS .41
201.5.4 DEFAULT ALARM PRESET .43
201.5.5 * Interruptions of less than or equal to 30 s .45
201.6 ALARM LIMIT .45
201.6.1 General requirements.45
201.6.2 * Adjustable ALARM LIMIT .45
201.7 * ALARM SYSTEM security.47
201.8 * ALARM SIGNAL inactivation states .47
201.8.1 * General.47
201.8.2 * Termination of inactivation of ALARM SIGNALS .49
60601-1-8 IEC:2005 – 5 –
201.8.3 * Indication and access.49
201.9 * ALARM RESET.51
201.10 * NON-LATCHING and LATCHING ALARM SIGNALS.51
201.11 * DISTRIBUTED ALARM SYSTEM.51
201.11.1 * Existence OF DISTRIBUTED ALARM SYSTEM .51
201.11.2 Requirements for DISTRIBUTED ALARM SYSTEM communication of
ALARM CONDITIONS.53
201.12 * ALARM CONDITION logging.53
Appendix D (normative) Symbols on marking .55
Annex AAA (informative) Rationale and guidance .65
Annex BBB (informative) Cross-reference of identification, marking, and documents .131
Annex CCC (informative) Guidance for auditory ALARM SIGNALS.139
Annex DDD (informative) Verbal ALARM SIGNALS.141
Annex EEE (normative) Reserved melodies for ALARM SIGNALS.147
Bibliography.149
Index of defined terms .153
Figu
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