Recognized standard
5364 Fifth edition 2016-09-01
FDA recognition 1-122 · ISO · Anesthesiology
Key facts
| Recognition number | 1-122 |
|---|---|
| Designation | 5364 Fifth edition 2016-09-01 |
| Title | Anaesthetic and respiratory equipment-Oropharyngeal airways |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of… |
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: