Recognized standard
10651-4 Second edition 2023-03
FDA recognition 1-162 · ISO · Anesthesiology
Key facts
| Recognition number | 1-162 |
|---|---|
| Designation | 10651-4 Second edition 2023-03 |
| Title | Lung ventilators - Part 4: Particular requirements for user-powered resuscitators |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered… |
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: