IEC 60601-2-47:2012

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.

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.

General Information

• Status: Published
• Publication Date: 15-Feb-2012
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 15-Mar-2012
• Completion Date: 16-Feb-2012

Relations

• Revises: IEC 60601-2-47:2001 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

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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

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