SIST EN 60601-1-8:2008

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SLOVENSKI STANDARD
01-januar-2008
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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 (IEC
60601-1-8:2006)
Medizinische elektrische Gerte - Teil 1-8: Allgemeine Festlegungen fr die Sicherheit
einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Alarmsysteme -
Allgemeine Festlegungen, Prfungen und Richtlinien fr Alarmsysteme in medizinischen
elektrischen Gerten und in medizinischen elektrischen Systemen (IEC 60601-1-8:2006)
Appareils lectromdicaux - Partie 1-8: Exigences gnrales pour la scurit de base et les
performances essentielles - Norme collatrale: Exigences gnrales, essais et guide pour
les systmes d'alarme des appareils et des systmes lectromdicaux (IEC 60601-1-8:2006)
Ta slovenski standard je istoveten z: EN 60601-1-8:2007
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EUROPEAN STANDARD
EN 60601-1-8
NORME EUROPÉENNE
July 2007
EUROPÄISCHE NORM
ICS 11.040.01 Supersedes EN 60601-1-8:2004 + A1:2006

English version
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
(IEC 60601-1-8:2006)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-8: Exigences générales Teil 1-8: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Exigences générales, Ergänzungsnorm: Alarmsysteme -
essais et guide pour les systèmes Allgemeine Festlegungen, Prüfungen
d'alarme des appareils und Richtlinien für Alarmsysteme
et des systèmes électromédicaux in medizinischen elektrischen Geräten
(CEI 60601-1-8:2006) und in medizinischen elektrischen
Systemen
(IEC 60601-1-8:2006)
This European Standard was approved by CENELEC on 2007-04-11. 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, Bulgaria, 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

© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-8:2007 E
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EN 60601-1-8:2007 - 2 -
Foreword
The text of document 62A/519/CDV, future edition 2 of IEC 60601-1-8, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in
medical practice, and ISO SC 3, Lung ventilators and related devices, of ISO TC 121, Anaesthetic and
respiratory equipment, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure
and was approved by CENELEC as EN 60601-1-8 on 2007-04-11.
The following date was 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) 2008-02-01
This European Standard supersedes EN 60601-1-8:2004 and its amendment A1:2006
(+ corrigendum October 2006). However, EN 60601-1-8:2004 remains valid until all the parts 2 that
are used in conjunction with it have been withdrawn. No date of withdrawal of conflicting national
standards (dow) has therefore been fixed. However, when Part 1-8 is used for appliances not covered
by a part 2, EN 60601-1-8:2004 is not to be used after 2009-09-12.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
This EN 60601-1-8 was revised to structurally align it with EN 60601-1:2006 and to implement the
decision of IEC SC 62A that the clause numbering structure of collateral standards written to
EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle
technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk
management process in EN 60601-1:2006.
In the 60601 series of publications, collateral standards specify general requirements for safety
applicable to
– a subgroup 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).
In this collateral standard the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in italic type. In addition, in Annex A text in italics indicates guidance that
describes means to achieve the safety objectives of this collateral standard;
− informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text
of tables is also in a smaller type;
− TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTES:
IN SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the six numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses
of Clause 6).
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- 3 - EN 60601-1-8:2007
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are
marked with an asterisk (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-8:2006 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/IEC 14971 NOTE Harmonized as EN ISO 14971:2000 (not modified).
__________
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EN 60601-1-8:2007 - 4 -
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 Data Graphical symbols for use on equipment - -
base
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
safety and essential performance

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

IEC 60601-1-6 2006 Medical electrical equipment - EN 60601-1-6 2007
Part 1-6: General requirements for basic
safety and essential performance -
Collateral standard: Usability

1)
IEC 60651 1979 Sound level meters EN 60651 1994
A1 1993 A1 1994
A2 2000 A2 2001
ISO 3744 1994 Acoustics - Determination of sound power EN ISO 3744 1995
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)
EN 60651 + A1 + A2 are superseded by EN 61672-1:2003 & EN 61672-2:2003, which are based on
IEC 61672-1:2002 & IEC 61672-2:2003.

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Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling
within the scope of this standard.
___________
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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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IEC 60601-1-8
Edition 2.0 2006-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences générales, essais et guide pour
les systèmes d’alarme des appareils et des systèmes électromédicaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.01 ISBN 2-8318-8826-3

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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60601-1-8 © IEC:2006 –– 2 – 3 – 60601-1-8 © IEC:2006
CONTENTS
FOREWORD.4
INTRODUCTION.7

1 * Scope, object and related standards .
...