EN 60601-1-8:2004/A1:2006

SLOVENSKI STANDARD
01-oktober-2006
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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/A1:2006)
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 (IEC 60601-1-8:2003/A1:2006)
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 (CEI 60601-1-8:2003/A1:2006)
Ta slovenski standard je istoveten z: EN 60601-1-8:2004/A1:2006
ICS:
11.040.01
13.320
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1-8/A1
NORME EUROPÉENNE
June 2006
EUROPÄISCHE NORM
ICS 11.040.01 Incorporates Corrigendum October 2006

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/A1:2006)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-8: Règles générales de sécurité - Teil 1-8: Allgemeine Festlegungen für die
Norme collatérale: Sicherheit -
Règles générales, essais et Ergänzungsnorm: Alarmsysteme -
recommandations pour les systèmes Allgemeine Festlegungen, Prüfungen und
d'alarme des appareils et des systèmes Richtlinien für Alarmsysteme in
électromédicaux medizinischen elektrischen Geräten und
(CEI 60601-1-8:2003/A1:2006) in medizinischen elektrischen Systemen
(IEC 60601-1-8:2003/A1:2006)
This amendment A1 modifies the European Standard EN 60601-1-8:2004; it was approved by CENELEC on
2006-04-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment 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 amendment 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, 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

© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-8:2004/A1:2006 E

Foreword
The text of document 62A/513/FDIS, future amendment 1 to IEC 60601-1-8:2003, prepared by SC 62A,
Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in
medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
amendment A1 to EN 60601-1-8:2004 on 2006-04-01.
The following dates were fixed:
– latest date by which the amendment has to be
implemented at national level by publication of
an identical national standard or by endorsement (dop) 2007-01-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2007-01-01
The contents of the corrigendum of October 2006 have been included in this copy.
__________
Endorsement notice
The text of amendment 1:2006 to the International Standard IEC 60601-1-8:2003 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
NORME
CEI
INTERNATIONALE IEC
60601-1-8
INTERNATIONAL
STANDARD
AMENDEMENT 1
AMENDMENT 1
2006-03
Amendement 1
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
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
© IEC 2006 Droits de reproduction réservés ⎯ Copyright - all rights reserved
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
F
PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-1-8 Amend. 1 © IEC:2006 – 3 –
FOREWORD
This amendment has been prepared by a Joint Working Group of 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 SC3: Lung ventilators
and related devices, of ISO technical committee 121: Anaesthetic and respiratory equipment.
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/513/FDIS 62A/524/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table. In ISO, the amendment has been approved by 17 P-
members out of 17 having cast a vote.
The committee has decided that the contents of this amendment and the base publication 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.
___________
INTRODUCTION
This amendment contains a revision to IEC 60601-1-8 (first edition, 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.
This amendment deals primarily with requirements for ALARM SYSTEMS that have global ALARM
OFF or AUDIO OFF ALARM SIGNAL inactivation states and with the requirements for REMINDER
SIGNALS.
To meet needs for change which were identified by users of this Collateral Standard, it was
necessary to amend the standard before the previously approved maintenance cycle date.

60601-1-8 Amend. 1 © IEC:2006 – 5 –
Page 25
201 * ALARM SYSTEMS
201.1.2 * ALARM CONDITION priority
e
Replace, on page 27, the existing note in Table 201 with the following:
e
Where practicable, MEDICAL ELECTRICAL EQUIPMENT with a therapeutic function incorporates one or more
automatic safety mechanisms to prevent immedia
...