EN 60601-2-51:2003

Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

Establishes particular requirements, in addition to the requirements of EN 60601-2-25, for the safety, including essential performance of recording and analysing single channel and multichannel electrocardiographs. These requirements shall apply particularly to - recording electrocardiographs; - electrocardiographs which are part of other medical electrical equipment, for example exercise testing systems, if this equipment is used to record ECGs for diagnostic purposes; - electrocardiographs which are used as output units for ECG data base management systems or electrocardiographs which are used as output units located at other places than the recording unit; - analysing electrocardiographs, systems, and computing devices which by means of electronic data processing and pattern recognition derive measurements (e.g. intervals and amplitudes) and diagnostic statements from the ECG; - those parts of patient monitors or other specialised electrocardiographs that are capable of performing the functions of the analysing electrocardiographs.

Medizinische elektrische Geräte - Teil 2-51: Besondere Festlegungen für die Sicherheit, einschließlich wesentlicher Leistungsmerkmale von aufzeichnenden und interpretierenden Einkanal- und Mehrkanal-Elektrokardiographen

Appareils électromédicaux - Partie 2-51: Règles particulières de sécurité et performances essentielles des électrocardiographes enregistreurs et analyseurs mono et multi-canaux

Etablit des exigences particulières, en complément des exigences de la CEI 60601-2-25 concernant la sécurité et les performances essentielles des électrocardiographes enregistreurs et analyseurs mono et multi-canaux. Ces exigences doivent s'appliquer en particulier aux - électrocardiographes enregistreurs; - électrocardiographes intégrés à d'autres appareils électromédicaux, tels que les systèmes d'épreuve d'effort, si ces appareils servent à l'enregistrement d'ECG à des fins de diagnostic; - électrocardiographes utilisés en tant qu'unités de sortie par des systèmes de gestion de base de données d'ECG ou aux électrocardiographes utilisés en tant qu'unités de sortie à d'autres endroits que l'unité d'enregistrement; - électrocardiographes analyseurs, systèmes et équipements informatiques qui à l'aide d'un traitement informatique et d'imagerie calculent des mesures (telles que des intervalles et des amplitudes) et établissent des diagnostics à partir de l'ECG; - parties d'appareils de surveillance de patients ou autres électrocardiographes spéciaux capables de remplir les fonctions d'un électrocardiographe analyseur.

Medicinska električna oprema - 2-51. del: Posebne varnostne zahteve, vključno z bistvenim delovanjem, za snemanje in analiziranje enokanalskih in večkanalskih elektrokardiografov (IEC 60601-2-51:2003)

General Information

• Status: Withdrawn
• Publication Date: 30-Jul-2003
• Withdrawal Date: 31-Mar-2006
• ICS: 11.040.55 - Diagnostic 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: 15-Sep-2018
• Completion Date: 15-Sep-2018
• 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 60601-2-51:2004 - Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003)

Relations

• Replaced By: EN 60601-2-25:2015 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-51:2004
01-marec-2004
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYHYNOMXþQR]
ELVWYHQLPGHORYDQMHP]DVQHPDQMHLQDQDOL]LUDQMHHQRNDQDOVNLKLQYHþNDQDOVNLK
HOHNWURNDUGLRJUDIRY,(&
Medical electrical equipment - Part 2-51: Particular requirements for safety, including
essential performance, of recording and analysing single channel and multichannel
electrocardiographs (IEC 60601-2-51:2003)
Medizinische elektrische Geräte - Teil 2-51: Besondere Festlegungen für die Sicherheit,
einschließlich wesentlicher Leistungsmerkmale von aufzeichnenden und
interpretierenden Einkanal- und Mehrkanal-Elektrokardiographen (IEC 60601-2-51:2003)
Appareils électromédicaux - Partie 2-51: Règles particulières de sécurité et
performances essentielles des électrocardiographes enregistreurs et analyseurs mono et
multi-canaux (CEI 60601-2-51:2003)
Ta slovenski standard je istoveten z: EN 60601-2-51:2003
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-51:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-51:2004

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SIST EN 60601-2-51:2004
EUROPEAN STANDARD EN 60601-2-51
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2003

ICS 11.040.55


English version


Medical electrical equipment
Part 2-51: Particular requirements for safety,
including essential performance, of recording and analysing
single channel and multichannel electrocardiographs
(IEC 60601-2-51:2003)


Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-51: Règles particulières Teil 2-51: Besondere Festlegungen
de sécurité et performances essentielles für die Sicherheit, einschließlich
des électrocardiographes enregistreurs wesentlicher Leistungsmerkmale von
et analyseurs mono et multi-canaux aufzeichnenden und interpretierenden
(CEI 60601-2-51:2003) Einkanal- und Mehrkanal-
Elektrokardiographen
(IEC 60601-2-51:2003)




This European Standard was approved by CENELEC on 2003-04-01. 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, Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and 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


© 2003 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-2-51:2003 E

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SIST EN 60601-2-51:2004
EN 60601-2-51:2003 - 2 -
Foreword

The text of document 62D/469/FDIS, future edition 1 of IEC 60601-2-51, 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 60601-2-51 on 2003-04-01.

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) 2004-02-01

– latest date by which the national standards conflicting
 with the EN have to be withdrawn (dow) 2006-04-01

Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes GG, HH, ZA and ZB are normative, annexes AA to FF and annex II are
informative.
Annexes ZA and ZB have been added by CENELEC.

In this particular 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

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