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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Standards Content (Sample)
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
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EN 60601-1-8:2004 - 2 -
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.
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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).
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