Recognized standard
80601-2-85 Edition 1.0 2021-03
FDA recognition 17-19 · ISO · Neurology
Key facts
| Recognition number | 17-19 |
|---|---|
| Designation | 80601-2-85 Edition 1.0 2021-03 |
| Title | Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Neurology |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The… |
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: