IEC 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.

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.

General Information

• Status: Published
• Publication Date: 09-Jul-2001
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Start Date: 16-Feb-2012
• Completion Date: 13-Feb-2026

Relations

• Revised: IEC 60601-2-47:2012 - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
• Effective Date: 05-Sep-2023

Overview

IEC 60601-2-47:2001 is the IEC particular standard that defines safety and essential performance requirements for ambulatory electrocardiographic systems (commonly known as Holter systems). It applies to systems that either (a) provide continuous recording and continuous analysis (allowing full re‑analysis) or (b) provide continuous analysis with limited or partial recording. The standard amends and supplements IEC 60601-1 (General Standard) and focuses on hazards, accuracy, labelling and testing specific to ambulatory ECG equipment.

Key topics and technical requirements

• Scope & Definitions: Clear definitions for terms such as ambulatory recorder, playback equipment, patient electrode, lead wire and continuous recorder. The standard excludes intermittent event recorders and refers to IEC 60601-2-25 and IEC 60601-2-27 where relevant.
• Safety & essential performance: Particular requirements take precedence over the General Standard to ensure patient and user safety during continuous ambulatory monitoring.
• Electrical and mechanical safety: Clauses cover dielectric strength, protection against electric shock and mechanical strength for equipment worn or carried by patients.
• Electromagnetic compatibility (EMC): Requirements and test methods for conductive and radiated emissions and immunity are included (see referenced test set‑ups and figures).
• Accuracy and analysis performance: Minimal performance requirements for automatic ECG measurement and analysis, and reporting formats for analyser outputs (tables reference reporting requirements and beat‑by‑beat matrices).
• Protection against hazardous output: Requirements for input dynamic range, common‑mode rejection, pacemaker pulse tolerance and other fault conditions (test circuits and signal waveforms are specified in figures).
• Identification, marking and documentation: Mandatory labelling, instructions for use and lead/ electrode identification requirements - including permanent marking and colour‑coding schemes for lead wires (two common schemes are provided).
• Constructional and component requirements: Guidance for patient cables, electrodes, connectors and overall assembly integrity.

Applications

IEC 60601-2-47 is used to design, verify and certify ambulatory ECG systems such as:

• Holter recorders (wearable ECG recorders)
• Playback and analysis workstations that receive recorder data
• Integrated recorder/analyser systems used in outpatient cardiac monitoring

It guides risk assessment, product development, bench testing and clinical safety documentation for devices that continuously record and/or analyse ECG signals.

Who should use this standard

• Medical device manufacturers (design, R&D, QA)
• Test laboratories and conformity assessment bodies
• Regulatory and compliance teams preparing technical files
• Clinical engineers and procurement officers evaluating ambulatory ECG systems

Related standards

• IEC 60601-1 (General requirements for medical electrical equipment)
• IEC 60601-1-2 (EMC collateral standard)
• IEC 60601-2-25 and IEC 60601-2-27 (standards addressing specific ECG devices - excluded where noted)

Keywords: IEC 60601-2-47, ambulatory electrocardiographic systems, Holter monitoring, ECG recorder, essential performance, medical device safety, EMC, lead colour coding.

Standards Content (Sample)

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
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
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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, exceptions and references: in smaller type,
– test specifications: in italic type,
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual edition of this publication may be issued at a later date.

– 6 – 60601-2-47 © IEC:2001(E)
INTRODUCTION
This Particular Standard concerns the safety of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.
It amends and supplements IEC 60601-1 (second edition 1988): Medical electrical equipment –
Part 1: General requirements for safety, as amended by its amendment 1 (1991) and its
amendment 2 (1995), hereinafter referred to as the General Standard. The requirements of this
Particular Standard take priority over those of the General Standard.
A “General guidance and rationale” for the requirements of this Particular Standard is included
in annex AA.
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this Standard.
An asterisk (*) by a clause or subclause number indicates that some explanatory notes are
given in annex AA of this Particular Standard.

60601-2-47 © IEC:2001(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-47: Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard specifies the particular safety requirements for AMBULATORY
ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101.
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.
If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal
performance requirements for measurement and analysis functions apply. Medical electrical
equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this
standard.
This standard does not apply to systems that do not continuously record and analyse the ECG
(for example, ‘intermittent event recorders’).
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety,
including essential performance, of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.

– 8 – 60601-2-47 © IEC:2001(E)
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2
(1995).
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the General
Standard including its collateral standards or as the General Requirement(s).
The numbering of sections and subclauses of this Particular Standard corresponds to that of
the General Standard. Changes to the text of the General Standard are specified by the
following words:
‘Replacement’ means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
‘Addition’ means that the text of this Particular Standard is additional to the requirements of the
General Standard.
‘Amendment’ means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Clauses, subclauses, tables and figures which are additional to those of the General Standard
are numbered starting from 101, additional appendices are lettered AA, BB, etc., and additional
items aa), bb), etc.
The term ‘this Standard’ is used to make reference to the General Standard and this Particular
Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
1.5 Collateral Standards
Addition:
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral standard: Electromagnetic compatibility – Requirements and tests
*2 Terminology and definitions
This clause of the General standard applies except as follows:
Additional definitions:
2.101
AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM (EQUIPMENT)
AMBULATORY RECORDER and a PLAYBACK EQUIPMENT, both of which may contain an analysis
function
NOTE This EQUIPMENT is often referred to as Holter monitoring equipment after its inventor Dr. Norman Holter.

60601-2-47 © IEC:2001(E) – 9 –
2.102
AMBULATORY RECORDER
recording EQUIPMENT worn or carried by the PATIENT including associated ELECTRODES and
cables for recording or recording and analysing heart action potentials
2.103
PLAYBACK EQUIPMENT
EQUIPMENT for monitoring and documenting functions into which data from the RECORDER is fed
NOTE This EQUIPMENT is usually stationary and commonly includes computing facilities.
2.104
ELECTROCARDIOGRAM (ECG)
visual record of heart action potentials
[IEC 60601-2-25:1993, definition 2.101]
2.105
LEAD
ELECTRODE and LEAD WIRE combination(s) used for a certain recording of ECG. Examples:
Einthoven limb LEAD II, Unipolar chest LEAD V5
[IEC 60601-2-25:1993, definition 2.103, modified]
2.106
PATIENT ELECTRODE
means in contact with a specified part of the body to detect heart action voltage in combination
with another means
[IEC 60601-2-25:1993, definition 2.104]
2.107
NEUTRAL ELECTRODE
reference point for differential amplifiers and/or interference suppression circuits, not forming
part of any ELECTROCARDIOGRAPH LEAD
[IEC 60601-2-25:1993, definition 2.107]
2.108
PATIENT CABLE
multiwire cable and associated connector(s) to connect the ELECTRODES to the AMBULATORY
RECORDER
[IEC 60601-2-25:1993, definition 2.109]
2.109
LEAD WIRE(S)
cable connected between the ELECTRODE and the AMBULATORY RECORDER.
2.110
CONTINUOUS RECORDER
EQUIPMENT which performs continuous analysis and/or recording of the ECG.

– 10 – 60601-2-47 © IEC:2001(E)
5 Classification
This clause of the General Standard applies except as follows:
5.6
Amendment:
Delete all but CONTINUOUS OPERATION.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
Additional item:
aa) LEAD identification
The LEAD(S) shall be permanently marked in such a manner that the proper LEAD can be
directly determined at both the ELECTRODE attachment end, and so constructed or marked as to
avoid incorrect connection to the EQUIPMENT.
If independent bipolar leads are being used, the channel assignment shall be clearly annotated
on the EQUIPMENT for reference. Also, the LEAD(S) shall be colour coded according to one of the
colour coding schemes of table 101.
Table 101 – LEAD colour codes
a b
ELECTRODE
Code 1 Code 2
Channel 1 Positive ELECTRODE green red
Negative ELECTRODE red white
Channel 2 Positive ELECTRODE white brown
Negative ELECTRODE yellow black
Channel 3 Positive ELECTRODE orange orange
Negative ELECTRODE blue blue
NEUTRAL ELECTRODE
black green
a
Code 1 is widely used in Europe and internationally.
b
Code 2 is widely used in North America – see AHA guidelines of 1985.
NOTE The desired polarity assignments are presented here, but equipment can deviate as long as the
deviation is properly labelled.
6.8.2 Instructions for use
Additional items:
aa) Advice shall be given on the following:
1) the procedures necessary for safe operation, drawing attention in the case of TYPE B
APPLIED PARTS to the safety hazard which may occur as a result of an inadequate
electrical installation;
60601-2-47 © IEC:2001(E) – 11 –
2) the type of electrical installation to which the EQUIPMENT may be safely connected,
including the connection to any POTENTIAL EQUALIZATION CONDUCTOR;
3) that conductive parts of ELECTRODES and associated connectors for TYPE BF APPLIED
PARTS or TYPE CF APPLIED PARTS, including the NEUTRAL ELECTRODE, should not contact
other conductive parts including earth;
4) the possible hazard caused by the summation of LEAKAGE CURRENTS when several
EQUIPMENTS are interconnected by coupling and/or a multiple portable socket-outlet.
bb) Clear instructions shall be provided if a specific type of battery or battery charging
procedure has to be used in order to fulfil the requirements of this Particular Standard.
cc) Clear instructions shall be provided for any use of the RECORDER in wet environments.
dd) The EQUIPMENT labelling shall clearly indicate whether or not its use is intended for infants
weighing less than 10 kg.
ee) The manufacturer shall disclose the method for calculating the heart rate.
ff) The manufacturer shall disclose the method for determining a pause.
gg) If the equipment is designed to detect and/or measure ST segment shifts, the manu-
facturer shall disclose in the operating manual or physician's guide the following:
• whether the ST analysis is performed on all LEADS using any or all calibration signals,
• whether there are OPERATOR selectable detection criteria for ST segment shifts (such
as displacement and slope parameters),
• how frequently ST segment shifts are summarised in the report (e.g., hourly) and
whether numbers of episodes, types of episodes (elevation or depression), and
durations of episodes are reported, or whether the report presents this information
episode by episode,
• whether ranges of heart rates, ranges of displacements and/or slope values during
each episode are reported.
SECTION TWO – ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply except as follows:
*10 Environmental conditions
10.2.1 Environment
Amendment:
For RECORDERS:
a) An ambient temperature range of 10 °C to 45 °C.
b) A relative humidity of 10 % to 95 %, without condensation.

– 12 – 60601-2-47 © IEC:2001(E)
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
20 Dielectric strength
This clause of the General Standard applies except as follows:
20.2 Particular requirements for EQUIPMENT with an APPLIED PART
Amendment:
B-b Does not apply to EQUIPMENT.
20.3 Values of test voltages
Addition:
B-d1 The test voltage shall be 1 500 V (CLASS I, CLASS II, and INTERNALLY POWERED
EQUIPMENT) between F-TYPE APPLIED PARTS and SIGNAL INPUT PARTS and SIGNAL OUTPUT
PARTS. This test does not apply if the I/O parts cannot be connected to external
EQUIPMENT while the device is PATIENT connected.
B-d2 The test voltage between F-TYPE APPLIED PARTS and ENCLOSURE other than SIGNAL INPUT
PARTS shall be determined by the MAINS VOLTAGE of the device and table V of the
General Standard. The requirement from the General Standard for a minimum
reference voltage of U = 250 V for INTERNALLY POWERED EQUIPMENT does not apply.
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
21 Mechanical strength
*21.5
Replacement:
Data acquisition by the AMBULATORY RECORDER may be interrupted during shock but data
acquired prior to the shock shall be unaffected and normal data acquisition shall resume within
60 s after the completion of the following test.
Compliance is tested as follows:
The RECORDER is dropped once from a height of 75 mm onto a 50 mm thick hardwood board
(for example, hardwood >600 kg/m ) lying flat on a rigid base such as a concrete floor and
making solid contact with the base on every face, edge and corner. If the recorder is normally
used with a pouch, the same type of pouch can be used during the testing. The RECORDER shall
be unaffected and shall resume normal data acquisition within 60 s of the shock.

60601-2-47 © IEC:2001(E) – 13 –
21.6
Replacement:
During transport or storage, or when not operating, the RECORDER shall not be damaged after
being subjected to shocks resulting from an 0,8 m drop onto a hard surface on any face, edge
or corner (pouch may be used, as above).
The RECORDER shall not suffer obvious damage as a result of this test and shall meet the
requirements of this Particular Standard.
Compliance is tested as follows:
The RECORDER is allowed to fall freely once from each of three different starting positions from
a height of 0,8 m onto a 50 mm thick hardwood board (for example, hardwood >600 kg/m )
which lies flat on a rigid base such as a concrete floor. If the recorder is normally used with a
pouch, the same type of pouch can be used during testing.
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard apply except as follows:
*36 ELECTROMAGNETIC COMPATIBILITY
IEC 60601-1-2:1993 applies except as follows:
36.201 Emissions
36.201.1 Radio frequency (RF) emissions
36.201.1.1
Replacement:
RECORDER shall comply with the requirements of CISPR 11, Group 1, Class B.
36.201.1.7
Replacement:
PATIENT-COUPLED EQUIPMENT AND/OR SYSTEM shall be tested with the PATIENT CABLES,
transducers, LEAD(S) and ELECTRODES attached to the EQUIPMENT and terminated in a load
simulating the PATIENT (figures 101 and 102).
Signal input/output cables (if applicable) shall be attached to the EQUIPMENT during the test
(see item a) of 36.202.2.2).
36.202 Immunity
Addition to paragraph 4:
Examples of indications of possible SAFETY HAZARDS include changes in operating state,
irrecoverable loss or change of stored data.

– 14 – 60601-2-47 © IEC:2001(E)
*36.202.1 Electrostatic discharge
Replacement:
Equipment and/or systems shall comply with IEC 61000-4-2. A level of ±6 kV shall apply for
contact discharge to conductive ACCESSIBLE PARTS and coupling planes. Additionally, a level of
±8 kV shall apply for non-conductive ACCESSIBLE PARTS.
The EQUIPMENT shall return to the previous operating mode within 10 s without loss of any
stored data.
*36.202.2 Radiated radio-frequency electromagnetic fields
36.202.2.1 Requirements
Amendment:
a) The AMBULATORY RECORDER shall comply with IEC 61000-4-3. The r.f. field level shall be
3 V/m.
36.202.2.2 Test conditions
Amendment:
a) 80 % amplitude modulation at a single modulation frequency in the range of 1 Hz to 5 Hz
shall be used.
The EQUIPMENT cable shall be bundled non-inductively to 1 m overall length and the signal
cable (if applicable) and POWER SUPPLY CORD (if applicable) shall be arranged horizontally
and vertically from the EQUIPMENT according to figure 102.
b) For EQUIPMENT, the test frequency shall be swept from 80 MHz to 1 000 MHz.
c) Delete, not applicable.
36.202.6 Magnetic fields
Addition:
The EQUIPMENT shall be exposed to a magnetic field intensity of 3 A/m magnetic flux density of
1 gauss at three times the line frequency. The performance requirements of this Particular
Standard shall be met and no data loss shall occur. This addition refers to IEC 61000-4-8.
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
The clauses and subclauses of this section of the General Standard apply.
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
The clauses and subclauses of this section of the General Standard apply.
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
The clauses and subclauses of this section of the General Standard apply except as follows:

60601-2-47 © IEC:2001(E) – 15 –
50 Accuracy of operating data
Addition:
*50.101 Automated analysis
EQUIPMENT having automated ECG analysis is required to fulfil the requirements of this section.
*50.101.1 Standard databases to be used to evaluate automated analyses
Four standard databases are available from three sources for evaluating ambulatory ECG
analysers and have been widely used for that purpose.
– AHA database: The American Heart Association Database for Evaluation of Ventricular
Arrhythmia Detectors (80 records, 30 min each);
– MIT database: The Massachusetts Institute of Technology–Beth Israel Hospital Arrhythmia
Database (48 records, 30 min each);
– NST database: The Noise Stress Test Database (12 records, 30 min each; supplied with
the MIT database);
– CU database: The Creighton University Sustained Ventricular Arrhythmia Database
(35 records, 8 min each; supplied with the MIT database).
The first three databases consist of digitised excerpts of two-channel Holter recordings, with
each beat labelled. The CU database contains digitised single-channel ECG recordings with
rhythm changes labelled. This is a complete list of those databases that are both adequate as
a basis for evaluation and generally available at present.
*50.101.2 Performance reporting requirements
50.101.2.1 Standard databases to be used for the performance test
The accuracy of QRS detection shall be tested using the AHA database, the MIT database, and
the NST database.
The accuracy of ventricular ectopic beat (VEB) detection shall be tested using the AHA
database, the MIT database, and the NST database.
If the EQUIPMENT is claimed to detect ventricular flutter or fibrillation (VF), its ability to do so
shall be tested using the CU database, the AHA database and the MIT database.
If the EQUIPMENT is claimed to detect supraventricular ectopic beats (SVEBs) or atrial flutter or
fibrillation (AF), its ability to do so shall be tested using the MIT database and the NST
database.
50.101.2.2 Record-by-record results
For each record, the following statistics shall be reported:
− QRS sensitivity and positive predictivity;
− VEB sensitivity and positive predictivity.
For each record, any of the following statistics that are relevant to the EQUIPMENT’s claimed
capabilities shall also be reported:

– 16 – 60601-2-47 © IEC:2001(E)
− VF episode sensitivity and positive predictivity;
− SVEB sensitivity and positive predictivity;
− AF episode sensitivity and positive predictivity.
50.101.2.3 Statistics
Based on the record-by-record reports required by 50.101.2.2, gross statistics summarising the
performance of the EQUIPMENT under test on each of the databases used for testing shall be
reported in tabular format as shown in table 102 and 103. Symbols and abbreviations used in
these tables are:
G gross statistic (calculated for the entire database)
+P positive predictivity
R required (if the EQUIPMENT is claimed to detect the abnormality, the statistic shall be
reported)
Se sensitivity
VEB ventricular ectopic beat
SVEB supraventricular ectopic beat
TP true positive
TN true negative
FP false positive
FN false negative
Table 102 – Reporting requirements for standard analyser outputs
Statistic AHA DB MIT DB NST DB CU DB
QRS Se (G) R R R –
QRS +P (G) R R R –
VEB Se (G) R R R –
VEB +P (G) R R R –
VEB Couplets Se (G) R R – R
VEB Couplets +P (G) R R – R
VEB Short Runs Se (G) R R – R
VEB Short Runs +P (G) R R – R
VEB Long Runs Se (G) R R – R
VEB Long Runs +P (G) R R – R
Table 103 – Reporting requirements for optional analyser outputs
Statistic AHA DB MIT DB NST DB CU DB
VF Episode Se (G) R R – R
VF Episode +P (G) R R – R
SVEB Se (G) – R R –
SVEB +P (G) – R R –
60601-2-47 © IEC:2001(E) – 17 –
50.101.2.4 Test methods
(NOTE For maximum legibility the text in subclauses a) to d) is not italicised.)
a) Use of the standard databases for test
Each record shall be supplied to the EQUIPMENT continuously from the beginning to the
end (that is, without rewinding or ‘fast forwarding’). This requirement applies only to the
manner in which the evaluator presents ECG samples to the EQUIPMENT under test and
in no way is to be construed as a restriction on the manner in which the EQUIPMENT
normally performs its analysis.
If the digitised ECG signals from the database records are pre-processed in any way
before presenting them as input to the equipment under test, the pre-processing shall
be disclosed in sufficient detail to permit a third party to reproduce the test. Pre-
processing includes, but is not limited to:
− resampling (i.e., conversion to a sampling rate different from that used in the
standard database files);
− reformatting (i.e., conversion of byte order, sample precision or numeric coding);
− rescaling (altering the signal amplitude, i.e, changing the gain);
− filtering performed by software or hardware not employed in the normal operating
mode of the equipment under test;
− conversion from digital to analogue signals.
If the evaluation of the equipment under test is performed using signals converted into
analogue form and supplied to the normal analogue inputs of the equipment, the
equipment's automatic gain control (AGC) will be allowed to adjust the gain automatic-
ally. If the evaluation is performed using digital data and the AGC is not digital but part
of the analogue front end of the equipment, the equipment may simulate its AGC
capabilities by an alternative method. This alternative method allows the ‘test mode’
that generates the ‘test annotations’ to emit an announcement that a ‘gain adjustment’
would be required prior to proceeding with analysing the ECG for each patient record.
This announcement should instruct the evaluator to adjust the gain of the ECG for either
one or both of the ECG channels. The evaluator shall then run the 'xform' (or equivalent)
program to adjust the ECG’s gain based on the instructions provided by the program.
This process shall be repeated until ‘no gain change’ is announced and the equipment
under test shall then automatically proceed with the ECG analysis.
Beat-by-beat comparisons, following the protocol described in 50.101.2.4 c), shall be
used to derive QRS Se, QRS +P, VEB Se, VEB +P, and (where applicable) SVEB Se
and SVEB +P. The protocol described in 50.101.2.4 d) shall be used to derive VF and
AF episode Se and +P, where applicable.
b) Use of annotation files
The test protocols described in 50.101.2.4 c) through 50.101.2.4 d) require that, for
each record, the output of the equipment has been recorded in an annotation file (the
test annotation file) in the same format as the reference annotation file for that record.
The equipment need not produce this file directly. Any automated procedure for doing
so is acceptable as long as it is disclosed. To perform the comparison between the test
annotation files and the reference annotation files, the programs supplied on the MIT-
BIH Arrhythmia Database CD-ROM (programs ‘bxb’, ‘rxr’, ‘epic’, ‘mxm’) or later versions
released by MIT or programs with equivalent function and output shall be used.
A manufacturer using programs other than the ones released by MIT shall show the
equivalence of his programs. The reference annotation files distributed with the
databases and used as input to these programs may not be altered in any way, except
that (where applicable) corrected reference annotation files obtained from the database
suppliers may be substituted for those originally distributed with the databases.
Within annotation files, beat labels are defined as follows:
− N: any beat that does not fall into the S, V, F, or Q categories described below
(normal or bundle branch block beat);
− S: supraventricular ectopic beat (SVEB): an atrial or nodal (functional)
premature or escape beat or an aberrant atrial premature beat;

– 18 – 60601-2-47 © IEC:2001(E)
− V: ventricular ectopic beat (VEB): a ventricular premature beat, an “R-on-T”
ventricular premature beat or a ventricular escape beat;
− F: fusion of a ventricular and a normal beat;
− Q: paced beat, fusion of a paced and normal beat or a beat that cannot be
classified.
Other labels are needed to facilitate the beat-by-beat comparison process defined in
50.102.2.4 c):
− U: label that marks a segment of unreadable data.
U labels appear in the database where beats cannot be located because of
excessive noise or signal loss in both channels.
In the MIT database, a pair of U labels marks the beginning and end of each
unreadable segment.
In the AHA database, a single U label marks the (approximate) centre of each
unreadable segment, which is assumed for testing purposes to begin 150 ms
after the previous beat label, and to end 150 ms before the following beat label.
In order to mark segments during which an equipment's analysis is suspended
(shut down) because of excessive noise or signal loss, or for any other reason,
equipment may also generate U labels. Beat labels are never paired with U labels
during beat-by-beat comparisons.
Extra beats are sometimes detected (false positive ‘QRS’) and true beats are
sometimes missed (false negative QRS). In order to perform beat-by-beat comparisons,
pseudo-beat labels are added to those in the reference and test annotation files, to
preserve a one-to-one correspondence between beat labels. They represent the
absence of a beat label. There are two types:
− X: a pseudo-beat label generated during a segment marked as unreadable;
− O: a pseudo-beat label generated at any other time.
In beat-by-beat comparisons, all beat labels are paired up. If either the reference or the
test annotation file contains an extra beat label that has no match in the other file, the
appropriate O or X label is paired with the extra label. This corresponds to a QRS
detection error – either a false detection (if the extra label is in the test annotation file)
or a missed beat (if it is in the reference annotation file). All such beat label pairs are
counted, including those that involve O or X labels. O and X labels are not used in run-
by-run comparisons (50.101.2.4 c)), or for VF and AF comparisons (50.101.2.4 d)),
since it is not necessary in these instances to pair individual beat labels.
Rhythm labels mark segments of ventricular flutter or fibrillation (VF) in the AHA and
MIT databases:
− [ : beginning of VF
− ] : end of VF
Beat labelling is discontinued between ‘[’ and ‘]’ labels. VF segments are excluded from
beat-by-beat comparisons. Additional rhythm labels mark changes in rhythm in the MIT
database. Those which mark segments of atrial flutter or fibrillation (AF, see the
documentation which accompanies each database) are used for evaluation of AF
detection, others are ignored. Beat labels are never paired with rhythm labels.
c) Beat-by-beat comparison
During a beat-by-beat comparison, reference beat labels and equipment beat labels are
matched up in pairs. To be considered a match, the absolute value of the difference
between the equipment's estimate of the time of occurrence of a beat and the time as
recorded in the reference annotation file shall not exceed 150 ms. If matching does not
occur within this window, the candidate beat is considered to have been missed or to be
an extra detection. The end product of a beat-by-beat comparison is a matrix in which
each element is a correct count of the number of beat label pairs of the appropriate
type:
60601-2-47 © IEC:2001(E) – 19 –
Table 104 – Beat-by-beat matrix
Algorithm label
Reference label
ns v f qo x
N NnNs Nv Nf Nq NoNx
S SnSs Sv Sf Sq SoSx
V VnVs Vv Vf Vq VoVx
F FnFs Fv Ff Fq FoFx
Q QnQs Qv Qf Qq QoQx
OOnOsOvOfOq
XXnXsXvXfXq
The beat-by-beat comparison is performed according to the following method:
1) Set the variable T to the time of the first reference beat label after the end of the
learning period and set the variable t to the time of the first test beat label after
the end of the learning period. Set all elements of the matrix to zero.
If T is within 150 ms of the beginning of the test period, it is possible that a
matching test beat label may be placed before the beginning of the test period. If
this occurs, it is counted as a match (t is set to the time of the matching test beat
label before going on to step 2). On the other hand, if t is within 150 ms of the
beginning of the test period and there is no matching reference beat label after
the beginning of the test period, the test annotation at t is not counted (t is set to
the time of the next test beat label before going on to step 2).
2) One of the following cases shall apply:
a) If t precedes T, set t′ to the time of the next test beat label (or to a time
beyond the end of the record if there are no more test beat labels). There are
now two possibilities:
(i) If T is closer to t than to t′, and t is within 150 ms (the match window) of T,
the beat labels at T and t are paired. The variable T is reset to the time of
the next reference beat label.
(ii) Otherwise, the test beat label at t is an extra detection. The extra label is
paired with an O or X ‘pseudo-beat’ label. The variable t is reset to the
value of t′.
b) If t does not precede T, set T′ to the time of the next reference beat label (or
to a time beyond the end of the record if there are no more reference beat
labels). There are again two possibilities:
(i) If t is closer to T than to T′, and t is within 150 ms of T, the beat labels at T
and t are paired. The variable t is reset to the time of the next test beat
label.
(ii) Otherwise, the equipment has missed the beat at T. The extra reference
beat label is paired with an O or X "pseudo-beat" label. The variable T is
reset to the value of T ′.
c) The matrix element corresponding to the beat label pair which was generated
in step b) is incremented.
d) Steps b) and c) are repeated until both t and T are set to times beyond the end
of the record.
During the derivation of the matrix, the procedure has to keep track of segments that
have been marked as unreadable or as VF in either the reference or the test
annotation file. During unreadable segments, pseudo-beat labels are X; at all other
times, pseudo-beat labels are O. Test beat labels generated during true VF segments
are not counted for these purposes. Reference beat labels present during equipment-
marked VF segments are paired with O pseudo-beat labels and counted like all other

– 20 – 60601-2-47 © IEC:2001(E)
missed beats. In principle, an unreadable segment or a VF segment may begin during
the learning period, this possibility shall be taken into account by software designed
to perform beat-by-beat comparisons.
The results of beat-by-beat comparisons are used to derive QRS sensitivity and
positive predictivity:
QTP = Nn + Ns + Nv + Nf + Nq + QFN = No + Nx
Sn + Ss + Sv + Sf + Sq + So + Sx +
Vn + Vs + Vv + Vf + Vq + Vo + Vx -+
Fn + Fs + Fv + Ff + Fq + Fo + Fx +
Qn + Qs + Qv + Qf + Qq Qo + Qx
QFP = On + Os + Ov + Of + Oq + Xn + Xs + Xv + Xf + Xq
QRS Se = QTP/(QTP + QFN) QRS +P = QTP/(QTP + QFP)
The results of beat-by-beat comparisons are used to derive VEB sensitivity and
positive predictivity:
VTP = Vv VFN = Vn + Vs + Vf + Vq + Vo + Vx
VFP = Nv + Sv + Ov + Xv
VEB Se = VTP/(VTP + VFN) VEB + P = VTP/(VTP + VFP)
Note that VTP and VFP do not include Fv or Qv, thus a detector is neither penalized nor rewarded for its
treatment of ventricular fusion beats and ambiguous beats.
SVEB sensitivity and positive predictivity are similarly defined:
SVTP = Ss SVFN = Sn + Sv + Sf + Sq + So + Sx
SVFP = Ns + Vs + Fs + Os + Xs
SVEB Se = SVTP/(SVTP + SVFN) SVEB +P = SVTP/(SVTP + SVFP)
Again, note that Qs is excluded from SVTP and SVFP, so that a detector's treatment of ambiguous
beats does not influence its measured SVEB detection performance.
d) VF and AF comparisons
For equipment which is claimed to detect VF, a VF comparison shall be performed.
This test requires the production of an annotation file based on the equipment's
outputs, containing (at a minimum) the times when the equipment has determined
that episodes of VF have begun or ended. Overlap exists during any interval in which
both the reference and algorithm annotations indicate that VF is in progress. Each
reference episode for which overlap exists is counted as a true positive for purposes
of determining VF episode sensitivity; any other reference episodes are counted as
false negatives. Similarly, each algorithm-marked episode for which overlap exists is
counted as a true positive for purposes of determining VF episode positive
predictivity, any other algorithm-marked episodes are counted as false positives.
For equipment which is claimed to detect AF, an AF comparison shall be performed.
This test is performed in the same manner as the VF comparison with the substitution
of ‘AF’ for each occurrence of ‘VF’ in the description above. Segments labelled as
atrial flutter in the reference annotation files shall be excluded from this comparison.

60601-2-47 © IEC:2001(E) – 21 –
From
...

IEC 60601-2-47
Edition 1.0 2001-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

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IEC 60601-2-47
Edition 1.0 2001-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.55 ISBN 2-8318-8583-3
– 2 – 60601-2-47 © CEI:2001
SOMMAIRE
AVANT-PROPOS .8
INTRODUCTION.12

SECTION UN – GÉNÉRALITÉS
1 Domaine d’application et objet .14
1.1 Domaine d'application.14
1.2 Objet.14
1.3 Normes Particulières .16
1.5 Normes Collatérales.16
*2 Terminologie et définitions .16
5 Classification.20
6 Identification, marquage et documentation .20
6.1 Marquage sur l’extérieur des APPAREILS ou des parties d’APPAREIL .20
6.8.2 Instructions d’utilisation.20

SECTION DEUX – CONDITIONS D'ENVIRONNEMENT
*10 Conditions d'environnement .22
10.2.1 Environnement.22

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
20 Tension de tenue .24
20.2 Exigences pour les APPAREILS comportant une PARTIE APPLIQUEE .24
20.3 Valeurs des tensions d'essai.24

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES
21 Résistance mécanique.24

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS
AUX RAYONNEMENTS NON DÉSIRÉS OU EXCESSIFS
*36 COMPATIBILITE ELECTROMAGNETIQUE.26
36.201 Emissions .26
36.201.1 Emissions de fréquences radioélectriques .26
36.202 Immunité.26
*36.202.1 Décharge électrostatique .28
*36.202.2 Champs électromagnétiques à fréquences radioélectriques
rayonnés.28
36.202.6 Champs magnétiques .28

SECTION SIX – PROTECTION CONTRE LES RISQUES D’IGNITION
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET AUTRES RISQUES
60601-2-47 © IEC:2001 – 3 –
CONTENTS
FOREWORD.9
INTRODUCTION.13

SECTION ONE – GENERAL
1 Scope and object .15
1.1 Scope.15
1.2 Object.15
1.3 Particular Standards .17
1.5 Collateral Standards .17
*2 Terminology and definitions .17
5 Classification.21
6 Identification, marking and documents .21
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts .21
6.8.2 Instructions for use .21

SECTION TWO – ENVIRONMENTAL CONDITIONS
*10 Environmental conditions .23
10.2.1 Environment.23

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength.25
20.2 Particular requirements for EQUIPMENT with an APPLIED PART.25
20.3 Values of test voltages.25

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.25

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
*36 ELECTROMAGNETIC COMPATIBILITY .27
36.201 Emissions .27
36.201.1 Radio frequency (RF) emissions.27
36.202 Immunity.27
*36.202.1 Electrostatic discharge .29
*36.202.2 Radiated radio-frequency electromagnetic fields.29
36.202.6 Magnetic fields.29

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
– 4 – 60601-2-47 © CEI:2001
SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
PRÉSENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .30
*50.101 Analyse automatisée.30
*50.101.1 Bases de données normalisées à utiliser pour évaluer les
analyses automatisées.30
*50.101.2 Exigences concernant les rapports de performance.30
*50.101.3 Rapport médical – exigences minimales .44
* 51 Protection contre les caractéristiques de sortie présentant des risques.46
*51.5 Sortie incorrecte .46
*51.5.1 Plage dynamique des entrées .46
*51.5.2 Impédance d'entrée.48
*51.5.3 Réjection de mode commun .50
*51.5.4 Précision du gain .52
*51.5.5 Stabilité du gain .52
*51.5.6 Etalonnage d'amplitude .52
*51.5.7 Bruit du système .52
*51.5.8 Diaphonie entre plusieurs voies.54
*51.5.9 Réponse en fréquence .54
*51.5.10 Dimension minimale des détails .58
*51.5.11 Fonctionnement en présence d'impulsions de stimulateur
cardiaque.58
*51.5.12 Précision des durées.58
*51.5.13 Norme pour le système de coordonnées de la sortie imprimée.60
*51.5.14 Réglages et commutation du gain.60
*51.5.15 Alignement temporel .60

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
SECTION DIX – RÈGLES DE CONSTRUCTION
*56 Composants et ensembles.62
*56.7 Batteries d'accumulateurs.62
*56.7.101 Temps de surveillance et conservation des données .62

Annexe L (normative) Références – Publications mentionnées dans la présente norme .74
Annexe AA (informative) Lignes directrices et justifications.76

INDEX DES TERMES DÉFINIS .94

Figure 101 – Montage d'essai pour l'essai d'émission conductrice
conformément à 36.201.1.64
Figure 102 – Montage d'essai pour l'essai d’immunité aux émissions rayonnées
conformément à 36.201.1 et 36.202.2 .66
Figure 103 – Signal d'essai pour l'essai de plage dynamique d'entrée
conformément à 51.5.1 .68
Figure 104 – Circuit général d'essai relatif à 51.5 .68
Figure 105 – Circuit d'essai pour la réjection en mode commun conformément à 51.5.3.70

60601-2-47 © IEC:2001 – 5 –
SECTION EIGHT – ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.31
*50.101 Automated analysis .31
*50.101.1 Standard databases to be used to evaluate automated analyses.31
*50.101.2 Performance reporting requirements .31
*50.101.3 Physician report – minimum requirements .45
*51 Protection against hazardous output .47
*51.5 Incorrect output .47
*51.5.1 Input dynamic range.47
*51.5.2 Input impedance .49
*51.5.3 Common mode rejection .51
*51.5.4 Gain accuracy.53
*51.5.5 Gain stability.53
*51.5.6 Amplitude calibration.53
*51.5.7 System noise .53
*51.5.8 Multichannel crosstalk.55
*51.5.9 Frequency response.55
*51.5.10 Minimum feature size .59
*51.5.11 Function in the presence of pacemaker pulses .59
*51.5.12 Timing accuracy.59
*51.5.13 Hard copy grid standard .61
*51.5.14 Gain settings and switching.61
*51.5.15 Temporal alignment .61

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
*56 Components and general assembly.63
*56.7 Batteries.63
*56.7.101 Monitoring time and retention of data.63

Appendix L (normative) References – Publications mentioned in this standard.75
Annex AA (informative) Guidance and rationale .77

INDEX OF DEFINED TERMS .95

Figure 101 – Test set-up for conductive emission test according to 36.201.1 .65
Figure 102 – Test set-up for radiated emission and radiated immunity test
according to 36.201.1 and 36.202.2.67
Figure 103 – Test signal for input dynamic range test according to 51.5.1.69
Figure 104 – General test circuit for 51.5.69
Figure 105 – Test circuit for common mode rejection according to 51.5.3.71

– 6 – 60601-2-47 © CEI:2001
Figure 106 – Circuit d'essai relatif à la tolérance des impulsions de stimulateur
cardiaque conformément à 51.5.11 .72

Tableau 101 – Codes couleurs des DERIVATIONS.20
Tableau 102 – Exigences pour l'indication des sorties normales des analyseurs .34
Tableau 103 – Exigences pour l'indication des sorties facultatives des analyseurs .34
Tableau 104 – Matrice «battement par battement» .40

60601-2-47 © IEC:2001 – 7 –
Figure 106 – Test circuit for pacemaker pulse tolerance according to 51.5.11 .73

Table 101 – LEAD colour codes .21
Table 102 – Reporting requirements for standard analyser outputs .35
Table 103 – Reporting requirements for optional analyser outputs .35
Table 104 – Beat-by-beat matrix.41

– 8 – 60601-2-47 © CEI:2001
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
___________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-47: Règles particulières de sécurité
et performances essentielles des systèmes
d'électrocardiographie ambulatoires

AVANT-PROPOS
1) La Commission Electrotechnique Internationale (CEI) est une organisation mondiale de normalisation composée
de l'ensemble des comités électrotechniques nationaux (Comités nationaux de la CEI). La CEI a pour objet de
favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de
l'électricité et de l'électronique. A cet effet, la CEI – entre autres activités – publie des Normes internationales,
des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au public (PAS) et des
Guides (ci-après dénommés «Publication(s) de la CEI»). Leur élaboration est confiée à des comités d'études,
aux travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations
internationales, gouvernementales et non gouvernementales, en liaison avec la CEI, participent également aux
travaux. La CEI collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des
conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de la CEI concernant les questions techniques représentent, dans la mesure
du possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de la CEI
intéressés sont représentés dans chaque comité d’études.
3) Les Publications de la CEI se présentent sous la forme de recommandations internationales et sont agréées
comme telles par les Comités nationaux de la CEI. Tous les efforts raisonnables sont entrepris afin que la CEI
s'assure de l'exactitude du contenu technique de ses publications; la CEI ne peut pas être tenue responsable de
l'éventuelle mauvaise utilisation ou interprétation qui en est faite par un quelconque utilisateur final.
4) Dans le but d'encourager l'uniformité internationale, les Comités nationaux de la CEI s'engagent, dans toute la
mesure possible, à appliquer de façon transparente les Publications de la CEI dans leurs publications
nationales et régionales. Toutes divergences entre toutes Publications de la CEI et toutes publications
nationales ou régionales correspondantes doivent être indiquées en termes clairs dans ces dernières.
5) La CEI n’a prévu aucune procédure de marquage valant indication d’approbation et n'engage pas sa
responsabilité pour les équipements déclarés conformes à une de ses Publications.
6) Tous les utilisateurs doivent s'assurer qu'ils sont en possession de la dernière édition de cette publication.
7) Aucune responsabilité ne doit être imputée à la CEI, à ses administrateurs, employés, auxiliaires ou
mandataires, y compris ses experts particuliers et les membres de ses comités d'études et des Comités
nationaux de la CEI, pour tout préjudice causé en cas de dommages corporels et matériels, ou de tout autre
dommage de quelque nature que ce soit, directe ou indirecte, ou pour supporter les coûts (y compris les frais
de justice) et les dépenses découlant de la publication ou de l'utilisation de cette Publication de la CEI ou de
toute autre Publication de la CEI, ou au crédit qui lui est accordé.
8) L'attention est attirée sur les références normatives citées dans cette publication. L'utilisation de publications
référencées est obligatoire pour une application correcte de la présente publication.
9) L’attention est attirée sur le fait que certains des éléments de la présente Publication de la CEI peuvent faire
l’objet de droits de propriété intellectuelle ou de droits analogues. La CEI ne saurait être tenue pour
responsable de ne pas avoir identifié de tels droits de propriété et de ne pas avoir signalé leur existence.
La Norme internationale CEI 60601-2-47 a été établie par le sous-comité 62D: Appareils
électromédicaux, du comité d'études 62 de la CEI: Equipements électriques dans la pratique
médicale.
Cette version bilingue, publiée en 2006-04, correspond à la version anglaise.
Le texte anglais de cette norme est issu des documents 62D/408/FDIS et 62D/411/RVD. Le
rapport de vote 62D/411/RVD donne toute information sur le vote ayant abouti à l'approbation
de cette norme.
La version française de cette norme n’a pas été soumise au vote.
Cette publication a été rédigée selon les Directives ISO/CEI, Partie 2.

60601-2-47 © IEC:2001 – 9 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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 organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. 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: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This bilingual version, published in 2006-04, corresponds to the English version.
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.
The French version of this standard has not been voted upon.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

– 10 – 60601-2-47 © CEI:2001
Dans la présente Norme Particulière, les caractères d'imprimerie suivants sont employés:
– exigences, dont la conformité peut être vérifiée par un essai, et définitions: caractères
romains,
– Notes, explications, conseils, introductions, énoncés de portée générale, exceptions et références: petits
caractères,
– modalités d'essais: caractères italiques
– TERMES DEFINIS A L’ARTICLE 2 DE LA NORME GENERALE OU DANS LA PRESENTE NORME
PARTICULIERE: PETITES MAJUSCULES.

Le comité a décidé que le contenu de cette publication ne sera pas modifié avant la date de
maintenance indiquée sur le site web de la CEI sous «http://webstore.iec.ch» dans les données
relatives à la publication recherchée. A cette date, la publication sera
• reconduite;
• supprimée;
• remplacée par une édition révisée, ou
• amendée.
60601-2-47 © IEC:2001 – 11 –
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, exceptions and references: in smaller type,
– test specifications: in italic type,
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result dateindicated 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.
– 12 – 60601-2-47 © CEI:2001
INTRODUCTION
La présente Norme Particulière concerne la sécurité des SYSTEMES ELECTROCARDIOGRAPHIQUES
AMBULATOIRES. Elle modifie et complète la CEI 60601-1 (deuxième édition 1988): Appareils
électromédicaux – Partie 1: Règles générales de sécurité, modifiée par son amendement 1
(1991) et son amendement 2 (1995), appelée Norme Générale dans la présente Norme. Les
exigences de la présente Norme Particulière priment sur celles de la Norme Générale.
Une section «Guide général et justifications» concernant les exigences de la présente Norme
Particulière se trouve à l’Annexe AA.
On estime qu'une connaissance des raisons ayant motivé l'établissement de ces exigences
facilitera non seulement l'application correcte de la norme, mais accélèrera aussi, le moment
venu, toute révision rendue nécessaire par les changements dans la pratique clinique ou par
les évolutions technologiques. Cette annexe ne fait cependant pas partie des exigences de la
présente Norme.
La présence d'un astérisque (*) à côté d'un numéro d'article ou de paragraphe indique que des
notes explicatives sont fournies à l'annexe AA de la présente Norme Particulière.

60601-2-47 © IEC:2001 – 13 –
INTRODUCTION
This Particular Standard concerns the safety of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.
It amends and supplements IEC 60601-1 (second edition 1988): Medical electrical equipment –
Part 1: General requirements for safety, as amended by its amendment 1 (1991) and its
amendment 2 (1995), hereinafter referred to as the General Standard. The requirements of this
Particular Standard take priority over those of the General Standard.
A “General guidance and rationale” for the requirements of this Particular Standard is included
in annex AA.
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this Standard.
An asterisk (*) by a clause or subclause number indicates that some explanatory notes are
given in annex AA of this Particular Standard.

– 14 – 60601-2-47 © CEI:2001
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-47: Règles particulières de sécurité
et performances essentielles des systèmes
d'électrocardiographie ambulatoires

SECTION UN – GÉNÉRALITÉS
Les articles et paragraphes correspondants de la Norme Générale s’appliquent avec les
exceptions suivantes:
1 Domaine d’application et objet
L’article correspondant de la Norme Générale s'applique, avec les exceptions suivantes:
1.1 Domaine d'application
Addition:
La présente Norme particulière spécifie les exigences spécifiques de sécurité applicables aux
SYSTEMES ELECTROCARDIOGRAPHIQUES AMBULATOIRES, tels que définis au 2.101.
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.
Si le SYSTEME ELECTROCARDIOGRAPHIQUE AMBULATOIRE offre une analyse automatique de l'ECG,
des exigences minimales de performances s'appliquent pour les fonctions de mesurage et
d'analyse. Les appareils électromédicaux couverts par les normes CEI 60601-2-25 et
CEI 60601-2-27 sont exclus du domaine d'application de la présente norme.
La présente norme ne s'applique pas aux systèmes qui n'enregistrent pas et n'analysent pas
l'ECG en continu (par exemple, «Enregistreurs d'événements intermittents»).
1.2 Objet
Remplacement:
L'objet de la présente Norme Particulière est d'établir des exigences particulières de sécurité,
y compris les performances essentielles, pour les SYSTEMES ELECTROCARDIOGRAPHIQUES
AMBULATOIRES.
60601-2-47 © IEC:2001 – 15 –
MEDICAL ELECTRICAL EQUIPMENT –

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

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard specifies the particular safety requirements for AMBULATORY
ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101.
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.
If the ambulatory electrocardiographic system offers automatic ECG analysis, minimal
performance requirements for measurement and analysis functions apply. Medical electrical
equipment covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this
standard.
This standard does not apply to systems that do not continuously record and analyse the ECG
(for example, ‘intermittent event recorders’).
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety,
including essential performance, of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.

– 16 – 60601-2-47 © CEI:2001
1.3 Normes Particulières
Addition:
La présente Norme Particulière fait référence à la CEI 60601-1 (1988): Appareils électro-
médicaux – Partie 1: Règles générales de sécurité, modifiée par son amendement 1 (1991) et
son amendement 2 (1995).
Dans un souci de concision, la CEI 60601-1 est désignée dans cette Norme Particulière soit
par l'expression «la Norme Générale y compris ses normes collatérales», soit par l'expression
«l’(les) Exigence(s) Générale(s)».
La numérotation des sections et des paragraphes de la présente Norme Particulière
correspond à celle de la Norme Générale. Les modifications apportées au texte de la Norme
Générale sont spécifiées par les termes suivants:
«Remplacement» signifie que l'article ou le paragraphe de la Norme Générale est
intégralement remplacé par le texte de la présente Norme Particulière.
«Addition» signifie que le texte de la présente Norme Particulière est donné en complément
des exigences de la Norme Générale.
«Modification» signifie que l'article ou le paragraphe de la Norme Générale est modifié comme
indiqué par le texte de la présente Norme Particulière.
Les articles, les paragraphes, les tableaux et les figures qui viennent compléter ceux de la
Norme Générale sont numérotés à partir de 101, les annexes complémentaires sont désignées
par AA, BB, etc. et les points complémentaires par aa), bb), etc.
L'expression «la présente norme» est utilisée pour faire référence à la Norme Générale et à la
présente Norme Particulière considérées ensemble.
Lorsque la présente Norme Particulière ne comprend pas de section, d'article ou de
paragraphe correspondant, la section, l’article ou le paragraphe de la Norme Générale, qui
peut être sans objet, s’applique sans modification; lorsqu’il est demandé qu’une partie
quelconque de la Norme Générale, bien que pertinente, ne s’applique pas, cela est
expressément mentionné dans la présente Norme Particulière.
1.5 Normes collatérales
Addition:
CEI 60601-1-2:1993, Appareils électromédicaux – Partie 1: Règles générales de sécurité – 2.
Norme Collatérale: Compatibilité électromagnétique – Prescriptions et essais
*2 Terminologie et définitions
L'article correspondant de la Norme Générale s'applique, avec les exceptions suivantes:
Définitions supplémentaires:
2.101
SYSTEME (APPAREIL) ELECTROCARDIOGRAPHIQUE AMBULATOIRE
ENREGISTREUR AMBULATOIRE et APPAREIL DE LECTURE pouvant tous deux contenir une fonction
d'analyse
NOTE Cet APPAREIL est souvent désigné sous le terme «appareil de surveillance Holter» du nom de son inventeur
le Dr. Norman Holter.
60601-2-47 © IEC:2001 – 17 –
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2
(1995).
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the General
Standard including its collateral standards or as the General Requirement(s).
The numbering of sections and subclauses of this Particular Standard corresponds to that of
the General Standard. Changes to the text of the General Standard are specified by the
following words:
‘Replacement’ means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
‘Addition’ means that the text of this Particular Standard is additional to the requirements of the
General Standard.
‘Amendment’ means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Clauses, subclauses, tables and figures which are additional to those of the General Standard
are numbered starting from 101, additional appendices are lettered AA, BB, etc., and additional
items aa), bb), etc.
The term ‘this Standard’ is used to make reference to the General Standard and this Particular
Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
1.5 Collateral Standards
Addition:
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral standard: Electromagnetic compatibility – Requirements and tests
*2 Terminology and definitions
This clause of the General standard applies except as follows:
Additional definitions:
2.101
AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM (EQUIPMENT)
AMBULATORY RECORDER and a PLAYBACK EQUIPMENT, both of which may contain an analysis
function
NOTE This EQUIPMENT is often referred to as Holter monitoring equipment after its inventor Dr. Norman Holter.

– 18 – 60601-2-47 © CEI:2001
2.102
ENREGISTREUR AMBULATOIRE
APPAREIL enregistreur porté par le PATIENT et comprenant les ELECTRODES et les câbles
associés pour enregistrer ou pour enregistrer et analyser les potentiels cardiaques
2.103
...