Recognized standard
5367 Fifth edition 2014-10-15
FDA recognition 1-103 · ISO · Anesthesiology
Key facts
| Recognition number | 1-103 |
|---|---|
| Designation | 5367 Fifth edition 2014-10-15 |
| Title | Anaesthetic and respiratory equipment - Breathing sets and connectors |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | ISO 5367:2014 specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and… |
At a glance
- None 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: