Recognized standard
80369-5: Edition 1.0 2016-03 80369-5:2016
FDA recognition 5-107 · IEC · General I (QS/RM)
Key facts
| Recognition number | 5-107 |
|---|---|
| Designation | 80369-5: Edition 1.0 2016-03 80369-5:2016 |
| Title | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)] Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General I (QS/RM) |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | This part of International Standard 80369 specifies dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES. Limb cuff inflation APPLICATIONS include… |
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: