EN 60601-2-27:2006

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

Specifies the particular safety requirements, including essential performance, for electrocardiographic (ECG) monitoring equipment. This standard is applicable to equipment used in a hospital environment. If the equipment is used outside the hospital environment, such as in ambulances and air transport, the equipment shall comply with this standard.

Medizinische elektrische Geräte - Teil 2-27: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographie-Überwachungsgeräten

Appareils électromédicaux - Partie 2-27: Exigences particulières de sécurité, incluant les performances essentielles, des appareils de surveillance d'électrocardiographie

Spécifie les exigences particulières relatives à la sécurité, incluant les performances essentielles des appareils de surveillance d'électrocardiographie (ECG). La présente norme s'applique aux appareils utilisés dans l'environnement hospitalier. Si l'appareil est utilisé hors de l'environnement hospitalier, par exemple dans les transports ambulanciers terrestres et aériens, l'appareil doit être conforme à la présente norme.

Medicinska električna oprema – 2-27. del: Posebne varnostne zahteve, vključno z bistvenimi lastnostmi za elektrokardiografsko nadzorno opremo (IEC 60601-2-27:2005)

General Information

• Status: Withdrawn
• Publication Date: 04-Apr-2006
• Withdrawal Date: 31-Oct-2008
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 22-Aug-2017
• Completion Date: 22-Aug-2017
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-27:2006 - Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

Relations

• Replaces: EN 60601-2-27:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
• Effective Date: 29-Jan-2023
• Replaced By: EN 60601-2-27:2014 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI SIST EN 60601-2-27:2006

STANDARD
oktober 2006
Medicinska električna oprema – 2-27. del: Posebne varnostne zahteve,
vključno z bistvenimi lastnostmi za elektrokardiografsko nadzorno opremo
(IEC 60601-2-27:2005)
Medical electrical equipment – Part 2-27: Particular requirements for the safety,
including essential performance, of electrocardiographic monitoring equipment (IEC
60601-2-27:2005)
ICS 11.040.50; 11.040.55 Referenčna številka
SIST EN 60601-2-27:2006(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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EUROPEAN STANDARD
EN 60601-2-27

NORME EUROPÉENNE
April 2006
EUROPÄISCHE NORM

ICS 11.040.50 Supersedes EN 60601-2-27:1994


English version


Medical electrical equipment
Part 2-27: Particular requirements for the safety,
including essential performance,
of electrocardiographic monitoring equipment
(IEC 60601-2-27:2005)


Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-27: Exigences particulières Teil 2-27: Besondere Festlegungen
de sécurité, incluant les performances für die Sicherheit einschließlich
essentielles, des appareils de surveillance der wesentlichen Leistungsmerkmale
d'électrocardiographie von Elektrokardiographie-
(CEI 60601-2-27:2005) Überwachungsgeräten
(IEC 60601-2-27:2005)




This European Standard was approved by CENELEC on 2005-11-01. 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, 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 60601-2-27:2006 E

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EN 60601-2-27:2006 - 2 -
Foreword
The text of document 62D/529/FDIS, future edition 2 of IEC 60601-2-27, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-27 on 2005-11-01.
This European Standard supersedes EN 60601-2-27:1994.
It introduces essential performance to electrocardiographic monitoring equipment such as defibrillator
protection, performance requirements and alarming.
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) 2006-11-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2008-11-01
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 makes reference to International Standards. Where the International Standard
referred to has been endorsed as a European Standard or a home-grown European Standard exists, this
European Standard shall be applied instead. Pertinent information can be found on the CENELEC web
site.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-27:2005 was approved by CENELEC as a European
Standard without any modification.
__________

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