Recognized standard
F1714-96 (Reapproved 2018)
FDA recognition 11-272 · ASTM · Orthopedic
Key facts
| Recognition number | 11-272 |
|---|---|
| Designation | F1714-96 (Reapproved 2018) |
| Title | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This guide describes a laboratory method using a weight-loss technique for evaluating the wear properties of materials or devices, or both, which are being considered for use as bearing surfaces of human-hip-joint replacement prostheses. The hip prostheses are evaluated in a device intended to… |
At a glance
- 10–99 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: