Recognized standard
17853 Third edition 2011-03-01
FDA recognition 11-336 · ISO · Orthopedic
Key facts
| Recognition number | 11-336 |
|---|---|
| Designation | 17853 Third edition 2011-03-01 |
| Title | Wear of implant materials - Polymer and metal wear particles - Isolation and characterization |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This International Standard specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissues excised… |
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: