Recognized standard
18250-3 First edition 2018-06
FDA recognition 5-139 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-139 |
|---|---|
| Designation | 18250-3 First edition 2018-06 |
| Title | Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
| Standards developer | International Organization for Standardization |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements… |
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: