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About This Item

 

Full Description

BS EN 60601-2-26:2015 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS (EEG) as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This standard is applicable to ME EQUIPMENT used in a clinical environment (e.g., hospital, physician's office, etc.).

This standard does not cover requirements for other equipment used in electroencephalography such as:
  • phono-photic stimulators;
  • electroencephalographic telemetry;
  • EEG data storage and retrieval;
  • ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy;
  • ambulatory electroencephalographic recorders.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and 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 relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.


Cross References:
IEC 60601-1-2:2007
IEC 60601-1:2005
IEC 60601-2-27:2011
EN 60601-1-2:2007
EN 60601-1-2:2007+corrigendum Mar.:2010
EN 60601-1:2006
EN 60601-1:2006+corrigendum Mar.:2010
EN 60601-1:2006+A12:2014
EN 60601-2-27:2014


Replaces BS EN 60601-2-26:2003 which remains current

All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN IEC 80601-2-26:2020


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

    • Most Recent
  2. BS EN 60601-2-26:2015

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

    • Historical Version
  3. BS 09/30172488 DC


    BS EN 60601-2-26. Medical electrical equipment. Part 2-26. Particular requirements for basic safety and essential performance of electroencephalographs

    • Historical Version
  4. BS EN 60601-2-26:2003


    Medical electrical equipment. Particular requirements for safety-Particular requirements for the safety of electroencephalographs

    • Historical Version
  5. BS EN 60601-2-26:1995


    Medical electrical equipment. Particular requirements for safety-Specification for electroencephalographs

    • Historical Version