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• Status: Withdrawn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
01-junij-2002
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DPEXODQWQHHOHNWURNDUGLRJUDIVNHVLVWHPHYNOMXþQR]ELVWYHQLPL]PRJOMLYRVWPL
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
__________
- 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, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of any
of these publications apply to this European Standard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies (including
amendments).
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 60601-1 1988 Medical electrical equipment EN 60601-1 1990
+ A1 1991 Part 1: General requirements for safety + A1 1993
+ corr. July 1994
+ A2 1995 + A2 1995
+ A13 1996
Annex ZB
(informative)
Other international publications mentioned in this standard
with the references of the relevant European publications
Publication Year Title EN/HD Year
IEC 60601-2-25 1993 Medical electrical equipment EN 60601-2-25 1995
+ A1 1999 Part 2-25: Particular requirements for + A1 1999
the safety of electrocardiographs
IEC 60601-2-27 1994 Part 2-27: Particular requirements for EN 60601-2-27 1994
the safety of electrocardiographic
monitoring equipment
SHEFFIELD, L.T., 1985 Recommendations for standards of--
et al instrumentation and practice in the use
of ambulatory electrocardiography (AHA
special report from the task force of the
Committee on Electrocardiography and
Cardiac Electrophysiology of the
Council on Clinical Cardiology)

INTERNATIONAL IEC
STANDARD
60601-2-47
First edition
2001-07
Medical electrical equipment –
Part 2-47:
Particular requirements for the safety,
including essential performance,
of ambulatory electrocardiographic systems
Appareils électromédicaux –
Partie 2-47:
Règles particulières de sécurité et performances essentielles
des systèmes d'électrocardiographie ambulatoires
 IEC 2001  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-47 © IEC:2001(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
SECTION ONE – GENERAL
1 Scope and object .7
2 Terminology and definitions.8
5 Classification.10
6 Identification, marking and documents.10
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions.11
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength.12
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.12
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE
RADIATION
36 Electromagnetic compatibility.13
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER
SAFETY HAZARDS
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
50 Accuracy of operating data .15
51 Protection against hazardous output .22
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly .29

60601-2-47 © IEC:2001(E) – 3 –
Appendix L (normative) References – Publications mentioned in this standard.35
Annex AA (informative) Guidance and rationale.36
Figure 101 – Test set-up for conductive emission test according 36.201.1. .30
Figure 102 – Test set-up for radiated emission and radiated immunity test according
to 36.201.1 and 36.202.2.31
Figure 103 – Test signal for input dynamic range test according to 51.5.1.32
Figure 104 – General test circuit for 51.5.32
Figure 105 – Test circuit for common mode rejection according to 51.5.3.33
Figure 106 – Test circuit for pacemaker pulse tolerance according to 51.5.11 .34
Table 101 – LEAD colour codes .10
Table 102 – Reporting requirements for standard analyser outputs .16
Table 103 – Reporting requirements for optional analyser outputs .16
Table 104 – Beat-by-beat matrix.19
Index of defined terms.44

– 4 – 60601-2-47 © IEC:2001(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-47: Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems
FOREWORD
1) The IEC (International Electrotechnical Commission) is a world-wide organisation for standardisation comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardisation in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees, any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organisations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organisation
for Standardisation (ISO) in accordance with conditions determined by agreement between the two
organisations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an inter-
national consensus of opinion on the relevant subjects since each technical committee has representation from
all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be responsible for any equipment
declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-47 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this standard is based upon the following documents:
FDIS Report on voting
62D/408/FDIS 62D/411/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annex AA is for information only.

60601-2-47 © IEC:2001(E) – 5 –
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type,
– notes, explanations, advice, introductions, general statements, exc
...