CEI EN 60601-2-26

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

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Organization: CEI
Publication Date: 1 January 2016
Status: active
Page Count: 36
ICS Code (Other medical equipment): 11.040.99
ICS Code (Diagnostic equipment): 11.040.55
scope:

This particular standard 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

Document History

February 1, 2018
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of electroencephalographs
A description is not available for this item.
CEI EN 60601-2-26
January 1, 2016
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of electroencephalographs
This particular standard 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...
April 1, 2004
Medical electrical equipment - Part 2: Particular requirements for the safety of electroencephalographs
La Norma specifica le prescrizioni particolari per la sicurezza di elettroencefalografi (EEG) ossia apparecchi che generano elettroencefalogrammi. Un encefalogramma è una visualizzazione o...
February 1, 1998
Apparecchi elettromedicali - Parte 2: Norme particolari per la sicurezza degli elettroencefalografi
La Norma specifica le prescrizioni particolari per la sicurezza di elettroencefalografi (EEG) come definiti in 2.102 e nel seguito indicati come apparecchi. Prescrizioni particolari per altri...
May 1, 1995
Apparecchi elettromedicali - Parte II: Norme Particolari per la sicurezza degli elettroencefalografi
La presente Norma è la versione italiana della Norma Europea CENELEC EN 60601-2-26, identica alla Pubblicazione IEC 601-2-26 (1994). Specifica le prescrizioni particolari per la sicurezza di...

References

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