Recognized standard
EN 1615:2000
FDA recognition 9-95 · CEN · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-95 |
|---|---|
| Designation | EN 1615:2000 |
| Title | Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing |
| Standards developer | European Committee for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Oct 17, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This European Standard specifies requirements for the design and testing or single-use enteral feeding catheters, single-use enteral giving sets and their connection systems. |
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: