Recognized standard
25539-1 Second edition 2017-02
FDA recognition 3-149 · ISO · Cardiovascular
Key facts
| Recognition number | 3-149 |
|---|---|
| Designation | 25539-1 Second edition 2017-02 |
| Title | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 3, HDE |
| Scope (excerpt) | ISO 25539-1:2017 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in… |
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: