Recognized standard
EN 1618:1997
FDA recognition 9-113 · CEN · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-113 |
|---|---|
| Designation | EN 1618:1997 |
| Title | Catheters other than intravascular catheters - Test methods for common properties |
| Standards developer | European Committee for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | Specifies test methods for corrosion resistance, tensile properties, leakage of fluids and air, water flow rate and security of connectors. |
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: