EN 60601-1-8:2007/A1:2013

SLOVENSKI STANDARD
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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
Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Alarmsysteme -
Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen
elektrischen Geräten und in medizinischen elektrischen Systemen
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
Ta slovenski standard je istoveten z: EN 60601-1-8:2007/A1:2013
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.

EUROPEAN STANDARD
EN 60601-1-8/A1
NORME EUROPÉENNE
March 2013
EUROPÄISCHE NORM
ICS 11.040.01
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/A1:2012)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-8: Exigences générales pour la Teil 1-8: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles - Leistungsmerkmale -
Norme collatérale: Exigences générales, Ergänzungsnorm: Alarmsysteme -
essais et guide pour les systèmes Allgemeine Festlegungen, Prüfungen und
d'alarme des appareils et des systèmes Richtlinien für Alarmsysteme in
électromédicaux medizinischen elektrischen Geräten und in
(CEI 60601-1-8:2006/A1:2012) medizinischen elektrischen Systemen
(IEC 60601-1-8:2006/A1:2012)
This amendment A1 modifies the European Standard EN 60601-1-8:2007; it was approved by CENELEC on
2013-01-02. 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 CEN-CENELEC Management Centre 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
CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-8:2007/A1:2013 E

Foreword
The text of document 62A/824/FDIS, future edition 1 of IEC 60601-1-8:2006/A1, 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 vote and approved by
CENELEC as EN 60601-1-8:2007/A1:2013.

The following dates are fixed:
(dop) 2013-10-02
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2016-01-02
• latest date by which the national
standards conflicting with the

document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
Endorsement notice
The text of the International Standard IEC 60601-1-8:2006/A1:2012 was approved by CENELEC as a
European Standard without any modification.

- 3 - EN 60601-1-8:2007/A1:2013
Replace the Annex ZA of EN 60601-1-8:2007 by the following:

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
+ corr. December 2006 Part 1: General requirements for basic safety + corr. March 2010
+ corr. December 2007 and essential performance + A11 2011
+ A1 2012
IEC 61672-1 2002 Electroacoustics - Sound level meters - EN 61672-1 2003
Part 1: Specifications
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices

ISO 3744 2010 Acoustics - Determination of sound power EN ISO 3744 2010
levels and sound energy levels of noise
sources using sound pressure - Engineering
methods for an essentially free field over a
reflecting plane
ISO 7000 - Graphical symbols for use on equipment - -

IEC 60601-1-8
Edition 2.0 2012-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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
CODE PRIX U
ICS 11.040.01 ISBN 978-2-83220-442-9

– 2 – 60601-1-8 Amend. 1 © IEC:2012
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, of IEC technical committee 62: Electrical equipment in
medical practice, and ISO subcommittee SC 3: Lung ventilators and related devices of
ISO technical committee 121: Anaesthetic and respiratory equipment.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/824/FDIS 62A/837/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 standard has been approved by 19 P-
members out of 21 having cast a vote.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability 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 TO THE AMENDMENT
The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue
has been identified with respect to pulse and burst testing. In addition, issues have been
raised by IEC/62D/MT 22, Electromedical diagnostic and patient monitoring equipment, during
implementation of alarm system requirements in particular standards within their scope of
work.
At the Brussels meeting, IEC/SC 62A accepted a proposal, based on ISO/TC 121/SC 3
st
Resolution Orebro 6, to develop the 1 amendment to IEC 60601-1-8:2006 to address the
issues identified above. IEC/SC 62A – ISO/TC 121/SC 3 Joint Working Group 2, Alarms, was
reactivated as a maintenance team to develop this amendment.
Foreword
Add the following note at the end of the Foreword:
NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

60601-1-8 Amend. 1 © IEC:2012 – 3 –
1.2 Object
In the first paragraph, change the print type of the defined terms "basic safety" and "essential
performance" to small caps.
1.3.1 IEC 60601-1
Replace the existing first dash with:
– "the general standard" designates IEC 60601-1 alone (latest edition including any
amendments);
2 Normative references
Replace the introductory paragraph with:
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
Replace the normative references for IEC 60417 and IEC 60601-1 with the following:
IEC 60417, Graphical symbols for use on equipment. Available from: symbols.info/equipment>
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
Delete the normative references for IEC 60601-1-2, and IEC 60601-1-6.
Replace the normative reference to IEC 60651:1979 and its Amendment 1 (1993) and
Amendment 2 (2000) with the following:
IEC 61672-1:2002, Electroacoustics – Sound level meters – Part 1: Specifications
Add the following normative reference:
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
Replace the normative references for ISO 3744:1994 and ISO 7000:1989 with the following:
ISO 3744:2010, Acoustics – Determination of sound power levels and sound energy levels of
noise sources using sound pressure – Engineering methods for an essentially free field over a
reflecting plane
ISO 7000, Graphical symbols for use on equipment. Available from: symbols.info/equipment>
– 4 – 60601-1-8 Amend. 1 © IEC:2012
3 Terms and definitions
Replace the existing first paragraph with the following:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012 and IEC 62366:2007, and the following terms and definitions
apply.
3.1
* ALARM CONDITION
Replace the existing definition with the following:
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS
SITUATION exists for which OPERATOR awareness or response is required
NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.
NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.
Add the following new definition:
3.37
* ACKNOWLEDGED
state of an ALARM SYSTEM initiated by OPERATOR action, where the auditory ALARM SIGNAL
associated with a currently active ALARM CONDITION is inactivated until the ALARM CONDITION no
longer exists
NOTE 1 ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.
NOTE 2 ACKNOWLEDGED can terminate after a predetermined time interval has elapsed.
6 Alarm systems
6.1 ALARM CONDITION
6.1.2 * ALARM CONDITION priority
Replace the existing title and text of this subclause including Table 1 with the following:
6.1.2 * Determination of ALARM CONDITIONS and assignment of priority
For each HAZARDOUS SITUATION where the MANUFACTURER has chosen to use an ALARM SYSTEM
as a means of RISK CONTROL, the MANUFACTURER shall assign an ALARM CONDITION and its
priority using Table 1.
For HAZARDOUS SITUATIONS where the onset of potential HARM is delayed and the potential
result of a failure to respond is discomfort or minor reversible injury, the MANUFACTURER may
determine that no ALARM CONDITION is required. In such cases, the MANUFACTURER may
implement an INFORMATION SIGNAL.
NOTE Not all LOW PRIORITY ALARM CONDITIONS require prompt notification of the OPERATOR. On this basis an
auditory ALARM SIGN
...