Recognized standard
80369-1 Second edition 2018-11
FDA recognition 5-121 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-121 |
|---|---|
| Designation | 80369-1 Second edition 2018-11 |
| 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 | Jan 14, 2019 |
| Scope (excerpt) | This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these… |
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: