Recognized standard
G175-13 (Reapproved 2021)
FDA recognition 1-99 · ASTM · Anesthesiology
Key facts
| Recognition number | 1-99 |
|---|---|
| Designation | G175-13 (Reapproved 2021) |
| Title | Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications |
| Standards developer | ASTM International |
| Specialty area | Anesthesiology |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | 1.1 For the purpose of this standard, a pressure regulator, also called a pressure-reducing valve, is a device intended for medical or emergency purposes that is used to convert a medical or emergency gas pressure from a high, variable pressure to a lower, more constant working pressure [21 CFR… |
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: