Recognized standard
80369-6 Second edition 2025-05
FDA recognition 5-146 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-146 |
|---|---|
| Designation | 80369-6 Second edition 2025-05 |
| 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 | Dec 22, 2025 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This document specifies requirements for small-bore connectors intended to be used for connections in neural applications. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific… |
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: