Recognized standard
F3172-15 (Reapproved 2021)
FDA recognition 3-179 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-179 |
|---|---|
| Designation | F3172-15 (Reapproved 2021) |
| Title | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | 1.1 This guide provides guidance for selecting an appropriate device (s) and determining an appropriate sample (s) (that is, number of samples) for design verification testing of endovascular devices. A methodology is presented to determine which device (s) should be selected for testing to verify… |
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: