Recognized standard
80369-6 First Edition 2016-03-15
FDA recognition 5-108 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-108 |
|---|---|
| Designation | 80369-6 First Edition 2016-03-15 |
| Title | Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. |
| Standards developer | International Organization for Standardization |
| Specialty area | General I (QS/RM) |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other… |
At a glance
- 10–99 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: