Recognized standard
10651-5 First edition 2006-02-01
FDA recognition 1-72 · ISO · Anesthesiology
Key facts
| Recognition number | 1-72 |
|---|---|
| Designation | 10651-5 First edition 2006-02-01 |
| Title | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 10651-5:2006 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use. ISO… |
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: