EN 60601-2-47:2001

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

Specifies the particular safety requirements for ambulatory electrocardiographic systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories.

Medizinische elektrische Geräte - Teil 2-47: Besondere Festlegungen für die Sicherheit einschließlich wesentlicher Leistungsmerkmale von ambulanten elektrokardiographischen Systemen

Appareils électromédicaux - Partie 2-47: Règles particulières de sécurité et performances essentielles des systèmes d'électrocardiographie ambulatoires

Spécifie les exigences particulières de sécurité applicables aux systèmes électrocardiographiques ambulatoires. Les systèmes des types suivants relèvent du domaine d'application de la présente norme: a) systèmes qui assurent un enregistrement en continu et une analyse en continu de l'ECG permettant une nouvelle analyse globale donnant des résultats essentiellement similaires. Les systèmes peuvent d'abord enregistrer et mémoriser l'ECG, puis l'analyser ultérieurement sur une unité distincte, ou ils peuvent enregistrer et analyser l'ECG simultanément. Le type de support de stockage utilisé ne relève pas de la présente norme. b) systèmes qui assurent une analyse en continu et seulement un enregistrement partiel ou limité ne permettant pas de nouvelle analyse globale de l'ECG. Les aspects de sécurité de la présente norme s'appliquent à tous les types de systèmes appartenant à l'une des catégories mentionnées ci-dessus.

Medicinska električna oprema - 2-47. del: Posebne varnostne zahteve za ambulantne elektrokardiografske sisteme, vključno z bistvenimi zmogljivostmi (IEC 60601-2-47:2001)

General Information

• Status: Withdrawn
• Publication Date: 25-Oct-2001
• Withdrawal Date: 30-Sep-2004
• 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: 14-Apr-2018
• Completion Date: 14-Apr-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to 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 60601-2-47:2002 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001)

Relations

• Replaced By: EN 60601-2-47:2015 - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-47:2002
01-junij-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
DPEXODQWQHHOHNWURNDUGLRJUDIVNHVLVWHPHYNOMXþQR]ELVWYHQLPL]PRJOMLYRVWPL
,(&
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including
essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-
47:2001)
Medizinische elektrische Geräte - Teil 2-47: Besondere Festlegungen für die Sicherheit
einschließlich wesentlicher Leistungsmerkmale von ambulanten
elektrokardiographischen Systemen (IEC 60601-2-47:2001)
Appareils électromédicaux - Partie 2-47: Règles particulières de sécurité et
performances essentielles des systèmes d'électrocardiographie ambulatoires (CEI
60601-2-47:2001)
Ta slovenski standard je istoveten z: EN 60601-2-47:2001
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-47:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-47:2002

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SIST EN 60601-2-47:2002
EUROPEAN STANDARD EN 60601-2-47
NORME EUROPÉENNE
EUROPÄISCHE NORM October 2001
ICS 11.040.55
English version
Medical electrical equipment
Part 2-47: Particular requirements for the safety,
including essential performance,
of ambulatory electrocardiographic systems
(IEC 60601-2-47:2001)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-47: Règles particulières de Teil 2-47: Besondere Festlegungen
sécurité et performances essentielles für die Sicherheit einschließlich
des systèmes d'électrocardiographie wesentlicher Leistungsmerkmale von
ambulatoires ambulanten elektrokardiographischen
(CEI 60601-2-47:2001) Systemen
(IEC 60601-2-47:2001)
This European Standard was approved by CENELEC on 2001-10-01. 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, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, 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
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-47:2001 E

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SIST EN 60601-2-47:2002
EN 60601-2-47:2001 - 2 -
Foreword
The text of document 62D/408/FDIS, future edition 1 of IEC 60601-2-47, 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 60601-2-47 on 2001-10-01.
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) 2002-07-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2004-10-01
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annex ZA is normative and annexes AA and ZB are informative.
Annexes ZA and ZB have been added by CENELEC.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller 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 60601-2-47:2001 was approved by CENELEC as a European
Standard without any modification.
__________

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SIST EN 60601-2-47:2002
- 3 - EN 60601-2-47:2001
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisio
...