IEC 80601-2-26:2019
2019-05
Abstract
This part of the 80601 International Standard 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 electroconvulsive 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.
NOTE See also 4.2 of the general standard.
General information
-
Status: PublishedPublication date: 2019-05Stage: International Standard confirmed [90.93]
-
Edition: 1Number of pages: 75
-
Technical Committee :ISO/TC 121/SC 3ICS :11.040.55
- RSS updates
Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Amendment 1
Edition 2024
Life cycle
-
Now
-
00
Preliminary
-
10
Proposal
-
20
Preparatory
-
30
Committee
-
40
Enquiry
-
50
Approval
-
60
Publication
-
90
Review
-
95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedIEC 80601-2-26:2019/Amd 1:2024
-
00