EN 60601-2-47:2015

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

IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those 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. 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'). 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.

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

Appareils électromédicaux - Partie 2-47: Exigences particulières pour la sécurité de base et les performances essentielles des systèmes d'électrocardiographie ambulatoires

La CEI 60601-2-47:2012 concerne la sécurité de base et les performances essentielles des SYSTEMES D'ELECTROCARDIOGRAPHIE AMBULATOIRES. Elle amende et complète la norme générale CEI 60601-1 (troisième édition 2005). Les exigences de la présente norme particulière prévalent sur celles de la norme générale. 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. 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 D'ELECTROCARDIOGRAPHIE 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 EM 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'). Cette deuxième édition annule et remplace la première édition publiée en 2001. Elle constitue une révision technique. Cette édition a été révisée pour l'alignement structurel à l'édition 2005 de la CEI 60601-1.

Medicinska električna oprema - 2-47. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ambulantnih elektrokardiografskih sistemov

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI AMBULANTNIH ELEKTROKARDIOGRAFSKIH SISTEMOV, v nadaljevanju ELEKTROMEDICINSKI SISTEMI. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini te točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
OPOMBA: Glej tudi točko 4.2 splošnega standarda.
Znotraj področja uporabe tega standarda so naslednji tipi sistemov:
a) sistemi, ki nudijo neprekinjeno snemanje in neprekinjeno analizo EKG-ja, kar omogoča ponovno analizo, ki daje podobne rezultate. Sistem lahko najprej posnamejo in shranijo EKG za poznejšo analizo na drugi napravi, ali hkrati posnamejo in analizirajo EKG. Vrsta uporabljenega medija za shranjevanje ni pomembna za potrebe tega standard;
b) sistemi, ki nudijo neprekinjeno analizo in le delno ali omejeno snemanje, kar ne omogoča ponovne analize EKG-ja.
Varnostni vidiki tega standarda veljajo za vse vrste sistemov, ki spadajo v eno od zgoraj omenjenih
kategorij.
Če AMBULANTNI ELEKTROKARDIOGRAFSKI SISTEM nudi samodejno analizo EKG-ja, veljajo minimalne
zahteve glede zmogljivosti za funkcije merjenja in analize. MEDICINSKA ELEKTRIČNA
OPREMA, zajeta v standardih IEC 60601-2-25 in IEC 60601-2-27, ne spada v področje uporabe tega standarda.
Ta standard se ne uporablja za sisteme, ki ne omogočajo neprekinjenega snemanja in analize EKG-ja (na primer, »snemalniki občasnih dogodkov«).

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: 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

Relations

• Replaces: EN 60601-2-47:2001 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
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

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.
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

– 2 – 60601-2-47 © IEC:2012
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

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

– 4 – 60601-2-47 © IEC:2012
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 Int
...