Recognized standard
80601-2-79 Second edition 2024-08
FDA recognition 1-185 · ISO · Anesthesiology
Key facts
| Recognition number | 1-185 |
|---|---|
| Designation | 80601-2-79 Second edition 2024-08 |
| Title | Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME… |
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: