Recognized standard
5360 Fourth edition 2016-02-15
FDA recognition 1-116 · ISO · Anesthesiology
Key facts
| Recognition number | 1-116 |
|---|---|
| Designation | 5360 Fourth edition 2016-02-15 |
| Title | Anaesthetic vaporizers - Agent specific filling systems |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 5360:2016 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers. ISO 5360:2016 does not specify construction materials. NOTE 1 For recommendations on materials, see Annex A. Because of the unique properties of desflurane… |
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: