IEC 60601-2-25:2011

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are:
a) the part of Medical electrical equipment that provides vectorcardiographic loops;
b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.

Appareils électromédicaux - Partie 2-25: Exigences particulières pour la sécurité de base et les performances essentielles des électrocardiographes

La CEI 60601-2-25:2011 s'applique à la sécurité de base et aux performances essentielles des électrocardiographes, destinés de par leur nature ou comme partie intégrante d'un système électro-médical, à la production de rapports d'électrocardiographie à des fins de diagnostic. Les appareils destinés à être utilisés dans des conditions environnementales extrêmes ou non maîtrisées à l'extérieur d'un hôpital ou du cabinet d'un médecin, telles que dans des ambulances et dans un aéronef, doivent satisfaire à la présente norme particulière. Des normes supplémentaires peuvent s'appliquer pour ces environnements d'utilisation. Ne relèvent pas du domaine d'application de la présente norme particulière:
a) la partie des appareils électro-médicaux qui fournit des boucles vecto-cardiographiques;
b) les appareils électro-médicaux de surveillance électrocardiographique ambulatoire couverts par la CEI 60601-2-47, lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic;
c) les moniteurs cardiaques couverts par la CEI 60601-2-27 lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic.
Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-25, parue en 1993, et la première édition de la CEI 60601-2-51, parue en 2003. La mise à jour des normes particulières afin de faire référence à la troisième édition de la norme générale a permis de fusionner les premières éditions de la CEI 60601-2-25 et de la CEI 60601-2-51 en une seule norme. Une remise en forme et des modifications techniques ont été effectuées. Cette deuxième édition de la CEI 60601-2-25 constitue une révision technique de ces deux normes.

General Information

• Status: Published
• Publication Date: 18-Oct-2011
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 31-Oct-2011
• Completion Date: 19-Oct-2011

Relations

• Replaces: IEC 60601-2-51:2003 - Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-25:1993/AMD1:1999 - Amendment 1 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-25 ®
Edition 2.0 2011-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-25: Particular requirements for the basic safety and essential performance
of electrocardiographs
Appareils électromédicaux –
Partie 2-25: Exigences particulières pour la sécurité de base et les performances
essentielles des électrocardiographes

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IEC 60601-2-25 ®
Edition 2.0 2011-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-25: Particular requirements for the basic safety and essential performance
of electrocardiographs
Appareils électromédicaux –
Partie 2-25: Exigences particulières pour la sécurité de base et les performances
essentielles des électrocardiographes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XD
ICS 11.040.55; 11.040.99 ISBN 978-2-88912-719-1

– 2 – 60601-2-25  IEC:2011
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
201.1 Scope, object and related standards. 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 HAZARDOUS SITUATIONS and fault conditions . 37
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 37
201.15 Construction of ME EQUIPMENT . 37
201.16 ME SYSTEMS. 37
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 37
202     Electromagnetic compatibility – Requirements and tests . 38
Annexes . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) ELECTRODES, their positions, identifications and colour codes . 51
Annex CC (informative) LEADS, their identification and colour codes (other than those
specified in 201.12.4.102) . 53
Annex DD (informative) Polarity of PATIENT LEADS (other than those specified in
201.12.4.102) . 54
Annex EE (informative) Additional marking of ELECTRODES . 55
Annex FF (informative) Definitions and rules for the measurement of
ELECTROCARDIOGRAMS . 56
Annex GG (informative) Calibration and test data sets . 61
Annex HH (informative) CTS test atlas . 63
Bibliography . 94
Index of defined terms used in this particular standard. 95

Figure 201.101 – ELECTRODE position according to Frank . 14
Figure 201.102 – Test of protection against the effects of defibrillation (differential

mode) (see 201.8.5.5.1) . 19
Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
(see 201.8.5.5.1) . 20
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 21

60601-2-25  IEC:2011 – 3 –
Figure 201.105 – Test circuit for COMMON MODE REJECTION and NOISE level . 28
Figure 201.106 – General test circuit . 30
Figure 201.107 – Triangular waveforms for test E of Table 201.107 . 32
Figure 201.108 – Input impulse signal and ELECTROCARDIOGRAPH response . 32
Figure 201.109 – Circuit for test of linearity. 34
Figure 201.110 – Result of linearity test . 34
Figure 201.111 – Pacemaker overload test circuit . 36
Figure 202.101 – Set-up for radiated and conducted emission test . 39
Figure 202.102 – Set-up for radiated immunity test . 40
Figure 202.103 – Test circuit for HF surgery protection measurement . 42
Figure 202.104 – Test setup for HF surgery protection measurement. 43
Figure BB.1a – LEADS and colours for fetal ECG (see Table BB.2) . 52
Figure BB.1b – Positions of the ELECTRODES on the fetus for fetal ECG (see Table BB.2) . 52
Figure BB.2 – LEAD positions and colours for fetal scalp ECG (see Table BB.2) . 52
Figure FF.1 – Normal ELECTROCARDIOGRAM . 56
Figure FF.2 – Determination of global intervals (example) . 57
Figure FF.3 – Waveform durations, isoelectric segments . 58
Figure FF.4 – QRS complex with small R-wave(s) (see Figure FF.5, FF.6) . 59
Figure FF.5 – Detail of small accepted R-wave . 60
Figure FF.6 – Detail of small rejected R-wave . 60
Figure HH.1 – Nomenclature of calibration ECGS . 66
Figure HH.2 – Nomenclature of analytical ECGs . 69

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – ELECTRODES, their position, identification and colour code . 14
Table 201.103 – Protection against the effect of defibrillation (test conditions) . 18
Table 201.104 – Acceptable mean differences and standard deviations for global
intervals and Q-, R-, S-durations on calibration and analytical ECGS . 23
Table 201.105 – Acceptable mean differences and standard deviations for global
durations and intervals for biological ECGs . 23
Table 201.106 – LEADS and their identification (nomenclature and definition) . 25
Table 201.107 – Frequency response . 31
Table 201.108 – PATIENT ELECTRODE connection for pacemaker pulse display test . 37
Table AA.1 – ELECTRODE positions and electrical strength requirements . 46
Table BB.1 – ELECTRODES, their positions, identifications and colour codes (other than
described in 201.7.4.101, Table 201.106) . 51
Table BB.2 – Other ELECTRODE-positions, identifications and colour codes not covered
by this particular standard . 51
Table DD.1 – ELECTRODE polarities . 54
Table EE.1 – Recommended identification and colour code for a 14-wire PATIENT CABLE . 55
Table GG.1 – CALIBRATION and analytical ECGS .
...