Recognized standard
10651-4 First edition 2002-03-01
FDA recognition 1-73 · ISO · Anesthesiology
Key facts
| Recognition number | 1-73 |
|---|---|
| Designation | 10651-4 First edition 2002-03-01 |
| Title | Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 10651-4:2002 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated… |
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: