Recognized standard
80369-7 Second edition 2021-05
FDA recognition 5-133 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-133 |
|---|---|
| Designation | 80369-7 Second edition 2021-05 |
| Title | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
| Standards developer | International Organization for Standardization |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. |
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: