SIST EN 60601-2-47:2015

SLOVENSKI STANDARD
SIST EN 60601-2-47:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-47:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLDPEXODQWQLKHOHNWURNDUGLRJUDIVNLKVLVWHPRY
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and
essential performance of ambulatory electrocardiographic systems
Medizinische elektrische Geräte - Teil 2-47: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von ambulanten
elektrokardiogrphischen Systemen
Appareils électromédicaux - Partie 2-47: Exigences particulières pour la sécurité de base
et les performances essentielles des systèmes d'électrocardiographie ambulatoires
Ta slovenski standard je istoveten z: EN 60601-2-47:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-47:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-47:2015

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SIST EN 60601-2-47:2015


EUROPEAN STANDARD EN 60601-2-47

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.55 Supersedes EN 60601-2-47:2001
English Version
Medical electrical equipment - Part 2-47: Particular requirements
for the basic safety and essential performance of ambulatory
electrocardiographic systems
(IEC 60601-2-47:2012)
Appareils électromédicaux - Partie 2-47: Exigences Medizinische elektrische Geräte - Teil 2-47: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des systèmes d'électrocardiographie wesentlichen Leistungsmerkmale von ambulanten
ambulatoires elektrokardiographischen Systemen
(IEC 60601-2-47:2012) (IEC 60601-2-47:2012)
This European Standard was approved by CENELEC on 2015-04-14. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-47:2015 E

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SIST EN 60601-2-47:2015
EN 60601-2-47:2015
Foreword
The text of document 62D/963/FDIS, future edition 2 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 approved by CENELEC as EN 60601-2-47:2015.
The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-47:2001.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-47:2012 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-25 NOTE Harmonized as EN 60601-2-25.
IEC 60601-2-27 NOTE Harmonized as EN 60601-2-27.
2

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SIST EN 60601-2-47:2015
EN 60601-2-47:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
In Annex ZA of EN 60601-1:2006 replace IEC 60601-1-2 by:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

3

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SIST EN 60601-2-47:2015
EN 60601-2-47:2015
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
4

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SIST EN 60601-2-47:2015



IEC 60601-2-47

®


Edition 2.0 2012-02




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical electrical equipment –

Part 2-47: Particular requirements for the basic safety and essential performance

of ambulatory electrocardiographic systems




Appareils électromédicaux –

Partie 2-47: Exigences particulières pour la sécurité de base et les performances


essentielles des systèmes d’électrocardiographie ambulatoires













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX XB


ICS 11.040.55 ISBN 978-2-88912-911-9



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-47:2015
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CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 14
201.13 HAZARDOUS SITUATIONS and fault conditions . 38
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 38
201.15 Construction of ME EQUIPMENT . 38
201.16 ME SYSTEMS. 39
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 39
202 Electromagnetic compatibility – Requirements and tests . 40
Annexes . 42
Annex AA (informative) Particular guidance and rationale . 43
Bibliography . 64
Index of defined terms used in this particular standard. 65

Figure 201.101 – General test circuit for 201.12.4.4 . 29
Figure 201.102 – Test signal for input dynamic range test according to 201.12.4.4.101 . 30
Figure 201.103 – Test circuit for common mode rejection according to 201.12.4.4.103 . 33
Figure 201.104 – Test circuit for pacemaker pulse tolerance according to
201.12.4.4.109 . 37
Figure 202.101 – Test set-up for conductive emission test according to 202.6.1.1.2 and
radiated emission and radiated immunity test according to 202.6.1.1.2 and 202.6.2.3.2 . 41

Table 201.101 – Distributed additional ESSENTIAL PERFORMANCE requirements . 11
Table 201.102 – LEAD WIRE colour codes . 13
Table 201.103 – Requirements for all arrhythmia algorithms . 17
Table 201.104 – Requirements for algorithms with optional capabilities . 18
Table 201.105 – Beat label classifications . 22
Table 201.106 – Example of noise floor calculation results . 24
Table 201.107 – Example of HRV test results . 25
Table 201.108 – Run sensitivity summary matrix . 25
Table 201.109 – Run positive predictivity summary matrix . 26

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60601-2-47 © IEC:2012 – 3 –
Table AA.1 – Records to be included in a complete test . 44
Table AA.2 – Example of a line-format, beat-by-beat performance report . 48
Table AA.3 – Condensed beat-by-beat summary matrix containing 11 elements . 49
Table AA.4 – Summary table (matrix format) of beat-by-beat comparison . 49
Table AA.5 – Example of a line-format SHUTDOWN report . 50
Table AA.6 – Example of a line-format report . 51
Table AA.7 – Example of VF performance report . 51
Table AA.8 – Example of false VF performance report . 51
Table AA.9 – Example of a line-format couplet and run performance report . 52
Table AA.10 – Example of device measurements of synthetic test patterns . 53
Table AA.11 – Example of predicted ideal values for synthetic test patterns . 54
Table AA.12 – Example of choice of test patterns . 54
Table AA.13 – Example of RMS interval differences . 57
Table AA.14 – Example of summary of frequency components . 58

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SIST EN 60601-2-47:2015
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-47: Particular requirements for the basic safety and 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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 2001. It constitutes a
technical revision. This edition was revised to align structurally with the 2005 edition of
IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/963/FDIS 62D/980/RVD

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

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SIST EN 60601-2-47:2015
60601-2-47 © IEC:2012 – 5 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated 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.

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SIST EN 60601-2-47:2015
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INTRODUCTION
This particular standard concerns the basic safety and essential performance of AMBULATORY
ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements IEC 60601-1 (third edition
2005): Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance, 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.

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SIST EN 60601-2-47:2015
60601-2-47 © IEC:2012 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

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



201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
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.
ECG
This standard does not apply to systems that do not continuously record and analyse the
(for example, ‘intermittent event recorders’).
201.1.2 Object
Replacement:
—————————
1
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

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The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.
201.1.3 Collateral Standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and
IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral 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 or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.

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Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests.
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
NOTE An index of defined terms is found beginning on page 64.
Additional definitions:
201.3.201
AF
ATRIAL FIBRILLATION
ATRIAL FLUTTER
ECG rhythm involving either no P-waves and irregular RR intervals (atrial fibrillation) or high
frequency flutter waves and regular or irregular RR intervals (atrial flutter)
201.3.202
AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM
ME SYSTEM, AMBULATORY RECORDER and a PLAYBACK EQUIPMENT, both of which may contain an
analysis function
Note 1 to entry: This ME SYSTEM is often referred to as Holter monitoring system after its inventor
Dr. Norman Holter.
201.3.203
AMBULATORY RECORDER
recording ME EQUIPMENT worn or carried by the PATIENT including associated ELECTRODES and
cables for recording heart action potentials
Note 1 to entry: An AMBULATORY RECORDER may also analyse the heart action potentials. It may record selectively
when significant events are detected, or continuously.
201.3.204
CONTINUOUS RECORDER
ME EQUIPMENT, which performs
...