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

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

Corrigendum to EN issued October 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

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

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 (IEC 60601-1-8:2003/A1:2006)

General Information

• Status: Withdrawn
• Publication Date: 30-Sep-2006
• Withdrawal Date: 30-Sep-2006
• ICS: 11.040.01 - Medical equipment in general
• ICS: 13.320 - Alarm and warning systems
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 10-Jun-2009
• Due Date: 03-Jul-2009
• Completion Date: 10-Jun-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-1-8:2004/A1:2006 - 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

Relations

• Amends: SIST EN 60601-1-8:2004 - 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: 01-Oct-2006
• Replaced By: 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
• Effective Date: 07-Jun-2022
• Replaced By: 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
• Effective Date: 01-Sep-2009
• Replaced By: 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
• Effective Date: 28-Jan-2023
• Amends: SIST EN 60601-1-8:2004 - 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: 28-Jan-2023
• Amends: SIST EN 60601-1-8:2004 - 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: 07-Jun-2022

Standards Content (Sample)

62A/498/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJET DE COMITÉ POUR VOTE (CDV)
Project number IEC 60601-1-8 Ed. 1.0 / A1
Numéro de projet

IEC/TC or SC: Date of circulation Closing date for voting (Voting
62A
Date de diffusion mandatory for P-members)
CEI/CE ou SC:

Date de clôture du vote (Vote
2005-05-27
obligatoire pour les membres (P))
2005-10-28
Titre du CE/SC: Aspects généraux des TC/SC Title: Common aspects of electrical
équipements utilisé en pratique médicale equipment used in medical practice
Secretary: USA
Secrétaire:
Also of interest to the following committees Supersedes document
Intéresse également les comités suivants Remplace le document
TC 62, SC 62B/C/D, TC 66, TC 76, 62A/470/DC and 62A/481/MCR
ISO/TC 106/SC 6, ISO/TC 121/SC 1 and SC 3,
ISO/TC 150/SC 6, CENELEC/TC 62
Functions concerned
Fonctions concernées
Safety EMC Environment Quality assurance
Sécurité
CEM Environnement Assurance qualité
CE DOCUMENT EST TOUJOURS À L'ÉTUDE ET SUSCEPTIBLE DE THIS DOCUMENT IS STILL UNDER STUDY AND SUBJECT TO CHANGE. IT
MODIFICATION. IL NE PEUT SERVIR DE RÉFÉRENCE. SHOULD NOT BE USED FOR REFERENCE PURPOSES.
LES RÉCIPIENDAIRES DU PRÉSENT DOCUMENT SONT INVITÉS À RECIPIENTS OF THIS DOCUMENT ARE INVITED TO SUBMIT, WITH THEIR
PRÉSENTER, AVEC LEURS OBSERVATIONS, LA NOTIFICATION DES COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF
DROITS DE PROPRIÉTÉ DONT ILS AURAIENT ÉVENTUELLEMENT WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING
CONNAISSANCE ET À FOURNIR UNE DOCUMENTATION EXPLICATIVE. DOCUMENTATION.



Titre : Amendement 1 à la CEI 60601-1-8 : Title :Amendment 1 to IEC 60601-1-8: Medical
Appareils électromédicaux – Partie 1-8: electrical equipment – Part 1-8:
Règles générales de sécurité – Norme General requirements for safety – Collateral
collatérale: Règles générales, essais et guides standard: General requirements, tests and
pour les systèmes d'alarme dans l'équipement guidance for alarm systems in medical electrical
électromédical et les systèmes électromédicaux equipment and medical electrical systems
Parallel CENELEC and ISO votes



ATTENTION ATTENTION

CDV soumis en parallèle au vote (CEI) Parallel IEC CDV/CENELEC Enquiry
et à l’enquête (CENELEC)
Copyright © 2005 International Electrotechnical Commission, IEC. All rights reserved. It is
permitted to download this electronic file, to make a copy and to print out the content for the sole
purpose of preparing National Committee positions. You may not copy or "mirror" the file or
printed version of the document, or any part of it, for any other purpose without permission in
writing from IEC.
FORM CDV (IEC) 2002-08-09

---------------------- Page: 1 ----------------------

– 2 – 62A/498/CDV

Note d'introduction Introductory note
Après avoir pris connaissance des préoccupations relatives Taking note of the safety concern raised in the German
à la sécurité soulevées par les commentaires allemands et comments and the resolution passed at the recent meeting
de la résolution approuvée à la récente réunion du of CENELEC/TC 62 urging IEC/TC 62 to take expeditious
CENELEC/TC 62 de presser le comité technique 62 de la action to address the issue, JWG2 met and produced this
CEI à intervenir rapidement pour traiter du problème, le draft amendment. The Secretariats intend to push forward
JWG2 s'est réuni et a établi le présent projet with this amendment with the goal of obtaining approval of
d'amendement. Les Secrétariats ont l'intention de faire the National Committees and Member Bodies for the
avancer le présent amendement dans le but d'obtenir technical changes necessary to address this issue and
l'approbation des Comités Nationaux et des Organismes eliminate the impediment to harmonization of
Membres en ce qui concerne les changements techniques EN IEC 60601-1-8 in Europe. In light of comment 8 in
nécessaires pour régler ce problème et pour éviter 62A/481/MCR, the Secretariats have decided to expedite
l'empêchement de l'harmonisation de la EN IEC 60601-1-8 processing of this amendment by omitting the Committee
en Europe. A la lumière du commentaire 8 du Stage.
62A/481/MCR, les Secrétariats ont décidé d'accélérer le
processus du présent amendement en passant l'étape du
Comité.
Le Comité National français nous rappelle la décision prise
The French National Committee reminds us of the decision
aux réunions du SC 62A de Francfort en octobre 2003
taken during the SC 62A and TC 62 meetings in Frankfurt,
concernant l'alignement structurel des normes collatérales
October 2003, concerning the structural alignment of the
sur la troisième édition de la CEI 60601-1 et de la priorité
collateral standards to the third edition of IEC 60601-1 and
donnée à cet alignement. Il est dans l'intention des
the priority given to this alignment. It is the intent of the
Secrétariats responsables, avec le présent amendement
responsible Secretariats to begin work on this alignment in
qui traite de la problématique allemande, de commencer en
parallel with this amendment that addresses the German
parallèle le travail de cet alignement. Les secrétariats se
issue. The Secretariats intend to circulate this aligned
proposent de diffuser cette (seconde) édition alignée de la (second) edition of IEC 60601-1-8 following the close of the
CEI 60601-1-8 dès la clôture du vote du FDIS de la
FDIS ballot of third edition of IEC 60601-1.
troisème édition de la CEI 60601-1.
Les aspects éditoriaux émanant des Comités Nationaux et Editorial issues raised by National Committees and Member
des Organismes Membres seront traités au cours de la Bodies will be addressed in the process of preparing the
préparation de la seconde édition pour aligner de manière second edition to structurally align IEC 60601-1-8 with the
structurelle la CEI 60601-1-8 avec la troisième édition de la third edition of IEC 60601-1. Technical issues raised by
CEI 60601-1. Les aspects techniques émanant d'autres other National Committees or Member Bodies will be dealt
Comités Nationaux ou d'autres Organismes Membres with in either an amendment to the second edition, or, if
seront traités, soit dans un amendement à la seconde sufficiently extensive, in a future third edition of IEC 60601-
édition, soit, s'ils sont suffisamment importants, dans une 1-8.
future édition de la CEI 60601-1-8.

---------------------- Page: 2 ----------------------

60601-1-8 / Amend 1 (E) © IEC:2005 – 3 – 62A/498/CDV
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/XX/FDIS 62A/XX/RVD

Full information on the voting for the approval of this standard can be found in the report on voting
indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will remain
1
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 ISO 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.

1
 The National Committees are requested to note that for this publication the maintenance result date is 2009.

---------------------- Page: 3 ----------------------

60601-1-8 / Amen
...

SLOVENSKI STANDARD
SIST EN 60601-1-8:2004/A1:2006
01-oktober-2006
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PHGLFLQVNLHOHNWULþQLRSUHPLLQPHGLFLQVNLKHOHNWULþQLKVLVWHPLK,(&
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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
SIST EN 60601-1-8:2004/A1:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

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

---------------------- Page: 2 ----------------------

EN 60601-1-8:2004/A1:2006 - 2 -

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.
__________

---------------------- Page: 3 ----------------------

NORME
CEI
INTERNATIONALE IEC
60601-1-8
INTERNATIONAL
2003
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: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
F
PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue

---------------------- Page: 4 ----------------------

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.

---------------------- Page: 5 ----------------------

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
...