Recognized standard
80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
FDA recognition 1-139 · ISO · Anesthesiology
Key facts
| Recognition number | 1-139 |
|---|---|
| Designation | 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) |
| Title | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable… |
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: