Recognized standard
25539-3 First edition 2011-12-01 25539-3:2011
FDA recognition 3-103 · ISO · Cardiovascular
Key facts
| Recognition number | 3-103 |
|---|---|
| Designation | 25539-3 First edition 2011-12-01 25539-3:2011 |
| Title | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Aug 20, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the… |
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: