Recognized standard
6474-1 Second edition 2019-03
FDA recognition 8-494 · ISO · Materials
Key facts
| Recognition number | 8-494 |
|---|---|
| Designation | 6474-1 Second edition 2019-03 |
| Title | Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This part of ISO 6474 specifies the characteristics of, and corresponding test methods for, a bio-compatible and bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. This document does not… |
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: