Recognized standard
80369-2 First edition 2024-09
FDA recognition 1-195 · ISO · Anesthesiology
Key facts
| Recognition number | 1-195 |
|---|---|
| Designation | 80369-2 First edition 2024-09 |
| Title | Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a… |
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: