Recognized standard
80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION
FDA recognition 17-23 · IEC · Neurology
Key facts
| Recognition number | 17-23 |
|---|---|
| Designation | 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION |
| Title | Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Neurology |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: