Recognized standard
25539-3 Second edition 2024-10
FDA recognition 3-198 · ISO · Cardiovascular
Key facts
| Recognition number | 3-198 |
|---|---|
| Designation | 25539-3 Second edition 2024-10 |
| Title | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included… |
At a glance
- 1–9 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: