Recognized standard
80369-1 Third edition 2025-10
FDA recognition 5-147 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-147 |
|---|---|
| Designation | 80369-1 Third edition 2025-10 |
| Title | Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which 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: