IEC 60601-2-26:2012
(Main)Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 60601-2-26:2012 standard applies to basic safety and essential performance of electroencephalographs used in a clinical environment (e.g., hospital, physician's office, etc.). This standard does not cover requirements for other equipment used in electroencephalography. This third edition cancels and replaces the second edition of IEC 60601-2-26 published in 2003. 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 IEC 60601-1:2005 Edition 3, through reformatting and technical changes.
Appareils électromédicaux - Partie 2-26: Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes
La CEI 60601-2-26:2012 s'applique à la sécurité de base et aux performances essentielles des électroencéphalographes utilisés dans un environnement hospitalier (par exemple, hôpital, cabinet médical, etc.). Les exigences propres à d'autres appareils également utilisés en électroencéphalographie ne sont pas du domaine de cette norme. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-26 publiée en 2003. L'objectif de cette troisième édition est de mettre à jour la présente norme particulière par rapport à la troisième édition de la norme générale CEI 60601-1:2005 Edition 3, par l'intermédiaire d'une nouvelle mise en forme et de modifications techniques.
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IEC 60601-2-26 ®
Edition 3.0 2012-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-26: Particular requirements for the basic safety and essential performance
of electroencephalographs
Appareils électromédicaux –
Partie 2-26: Exigences particulières pour la sécurité de base et les performances
essentielles des électroencéphalographes
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IEC 60601-2-26 ®
Edition 3.0 2012-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-26: Particular requirements for the basic safety and essential performance
of electroencephalographs
Appareils électromédicaux –
Partie 2-26: Exigences particulières pour la sécurité de base et les performances
essentielles des électroencéphalographes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX U
ICS 11.040.55; 11.040.99 ISBN 978-2-83220-117-6
– 2 – 60601-2-26 © IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents. 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
201.10 Protection against unwanted and excessive radiation HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS . 23
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 23
202 ELECTROMAGNETIC COMPATIBILITY – Requirements and tests . 23
Annexes . 26
Annex AA (informative) Particular guidance and rationale . 27
Index of defined terms used in this particular standard. 29
Figure 201.101 – Test of protection against the effects of defibrillation (common mode) . 14
Figure 201.102 – Test of protection against the effects of defibrillation (differential
mode) . 15
Figure 201.103 – Application of the test voltage between LEAD WIRES to test the energy
delivered by the defibrillator . 16
Figure 201.104 – General test circuit . 20
Figure 201.105 – Test circuit for COMMON MODE REJECTION . 22
Figure 202.101 – Test layout for radiated and conducted EMISSION test and radiated
immunity test . 24
Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2 . 25
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 10
60601-2-26 © IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-26: Particular requirements for the basic safety
and essential performance of electroencephalographs
FOREWORD
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International standard IEC 60601-2-26 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition of IEC 60601-2-26 published in
2002. This edition constitutes a technical revision to the new structure of the third edition
(2005) of IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/990/FDIS 62D/1012/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.
– 4 – 60601-2-26 © IEC:2012
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
...
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