Recognized standard
5359 Fourth edition 2014-10-01
FDA recognition 1-129 · ISO · Anesthesiology
Key facts
| Recognition number | 1-129 |
|---|---|
| Designation | 5359 Fourth edition 2014-10-01 |
| Title | Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 5359:2014 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for… |
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: