BS EN IEC 80601-2-26:2020 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of electroencephalographs

BS EN IEC 80601-2-26:2020

Medical electrical equipment. Particular requirements for the basic safety and essential performance of electroencephalographs

Status : Current, Under review   Published : April 2020

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IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators; – EEG data storage and retrieval; – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document. IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.




Standard NumberBS EN IEC 80601-2-26:2020
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of electroencephalographs
StatusCurrent, Under review
Publication Date06 April 2020
Normative References(Required to achieve compliance to this standard)EN 60601-1-2:2015, EN 60601-1:2006/A12:2014, EN 60601-1:2006, EN IEC 60601-2-2:2018, IEC 60601-1-6:2013, IEC 60601-1-11:2015, IEC 60601-1:2005, EN 60601-1:2006/corrigendum Mar. 2010, EN 60601-1:2006/A11:2011, IEC 60601-2-2:2017, IEC 60601-1-2:2014, IEC 60601-1-12:2014, EN 60601-1-11:2015
Informative References(Provided for Information)IEC 60601-1-10, EN 60601-1-9, EN 60601-1-10, IEC 60601-1-3, EN 60601-1-3, IEC 60601-1-9, EN 62366-1:2015, IEC 62366-1:2015
ReplacesBS EN 60601-2-26:2015
International RelationshipsEN IEC 80601-2-26:2020,IEC 80601-2-26:2019
Draft Superseded By17/30347827 DC
DescriptorsGraphic symbols, Electrical equipment, Neurology, Performance testing, Medical equipment, Electronic equipment and components, Electrical medical equipment, Electroencephalographs, Circuits, Leakage currents, Safety measures, Clinical investigation instruments, Electrical safety, Instructions for use, Leakage paths, Safety engineering, Marking, Equipment safety
ICS11.040.01
11.040.55
11.040.99
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen
CommitteeCH/62/4
ISBN978 0 580 95593 8
PublisherBSI
FormatA4
DeliveryYes
Pages42
File Size1.405 MB
Price£218.00


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