Recognized standard
5834-1 Fourth edition 2019-02
FDA recognition 8-501 · ISO · Materials
Key facts
| Recognition number | 8-501 |
|---|---|
| Designation | 5834-1 Fourth edition 2019-02 |
| Title | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It is not applicable to finished products. |
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: