IEC 60601-2-27:2011
(Main)Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy.
Appareils électromédical - Partie 2-27: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance d'électrocardiographie
La CEI 60601-2-27:2011 s'applique aux appareils de surveillance électrocardiographique utilisés dans un environnement hospitalier, ainsi qu'en dehors de cet environnement, tels que dans les ambulances et les moyens de transport aérien. La présente norme particulière s'applique également aux systèmes de télémétrie ECG utilisés dans un environnement hospitalier. Les appareils de surveillance électrocardiographique conçus pour être utilisés dans des conditions extrêmes ou dans des conditions d'environnement non contrôlées à l'extérieur de l'environnement hospitalier, tels que dans les ambulances ou les moyens de transport aérien, doivent être conformes à la présente norme particulière. Des normes supplémentaires peuvent s'appliquer pour ces environnements d'utilisation. La présente norme ne s'applique pas aux moniteurs d'électrocardiographie pour une utilisation à domicile. Il convient cependant que les fabricants envisagent d'utiliser les articles correspondants de la présente Norme, en fonction de leur application à l'utilisation prévue. Les moniteurs ambulatoires (dits "Holter"), la surveillance de la fréquence cardiaque foetale, les dispositifs pléthysmographiques de pouls et les autres appareils d'enregistrement d'ECG n'entrent pas dans le domaine d'application de la présente norme particulière. L'objet de la présente troisième édition est de mettre à jour la présente norme particulière en prenant en compte la troisième édition de la norme générale par un reformatage et des modifications techniques. Le contenu du corrigendum de mai 2012 a été pris en considération dans cet exemplaire.
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IEC 60601-2-27 ®
Edition 3.0 2011-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-27: Particular requirements for the basic safety and essential performance
of electrocardiographic monitoring equipment
Appareils électromédicaux –
Partie 2-27: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance d’électrocardiographie
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IEC 60601-2-27 ®
Edition 3.0 2011-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-27: Particular requirements for the basic safety and essential performance
of electrocardiographic monitoring equipment
Appareils électromédicaux –
Partie 2-27: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance d’électrocardiographie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.50 ISBN 978-2-88912-430-5
– 2 – 60601-2-27 IEC:2011
CONTENTS
FOREWORD. 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 11
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 . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions . 41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 41
201.15 Construction of ME EQUIPMENT . 41
201.16 ME SYSTEMS . 42
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 42
202 Electromagnetic compatibility – Requirements and tests . 42
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 47
Annexes . 53
Annex AA (informative) Particular guidance and rationale . 54
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 65
Bibliography . 68
Index of defined terms used in this particular standard . 69
Figure 201.101 – Alternating QRS complexes and ventricular tachycardia waveforms
for testing pattern recognition capability according to 201.7.9.2.9.101 b) 4) and 6). . 16
Figure 201.102 – Test of protection against the effects of defibrillation (differential
mode) . 20
Figure 201.103 – Test of protection against the effects of defibrillation (common mode) . 21
Figure 201.104 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 22
Figure 201.105 – General test circuit . 26
Figure 201.106 – High frequency response . 31
Figure 201.107 – Test circuit for COMMON MODE REJECTION . 33
Figure 201.108 – Baseline reset . 34
Figure 201.109 – Pacemaker pulse . 35
Figure 201.110 – Test waveforms for T-wave rejection . 37
Figure 201.111 – Normal paced rhythm . 37
60601-2-27 IEC:2011 – 3 –
Figure 201.112 – Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at
80 1/min) . 38
Figure 201.113 – Simulated QRS complex . 38
Figure 201.114 – Pacemaker test circuit . 38
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated
immunity test . 43
Figure 202.102 – Set-up for radiated IMMUNITY test . 44
Figure 202.103 – Test circuit for HF surgery protection measurement . 46
Figure 202.104 – Test setup for HF surgery protection measurement . 47
Figure AA.1 – APPLIED PART with multiple PATIENT CONNECTIONS . 56
Figure BB.101 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 65
Figure BB.102 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 65
Figure BB.103 – LATCHING ALARM SIGNALS with ALARM RESET . 66
Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET . 66
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
Table 201.102 – ELECTRODES and NEUTRAL ELECTRODE, their position, identification and
colour . 13
Table 201.103 – Protection against the effect of defibrillation (test conditions) . 19
Table 208.101 – ALARM CONDITION priorities . 48
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS . 49
Table AA.1 – Electrode positions and electrical strength requirements . 55
– 4 – 60601-2-27 IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-27: Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment
FOREWORD
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