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)

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 (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)

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• Status: Withdrawn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: 31-May-2002
• Withdrawal Date: 09-May-2018
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 10-May-2018
• Due Date: 02-Jun-2018
• Completion Date: 10-May-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
• Ref Project: EN 60601-2-47:2001 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

Relations

• Replaced By: SIST 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
• Replaced By: SIST 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: 01-Sep-2015
• Replaced By: SIST 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: 07-Jun-2022

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, 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)

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SIST EN 60601-2-47:2002

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SIST EN 60601-2-47:2002
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

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SIST EN 60601-2-47:2002
– 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

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SIST EN 60601-2-47:2002
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

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SIST EN 60601-2-47:2002
– 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.

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SIST EN 60601-2-47:2002
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.

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SIST EN 60601-2-47:2002
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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.

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SIST EN 60601-2-47:2002
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.

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SIST EN 60601-2-47:2002
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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.

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SIST EN 60601-2-47:2002
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.

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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;

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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.

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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
3
(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.

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SIST EN 60601-2-47:2002
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
3
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
...