Recognized standard
13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15
FDA recognition 8-593 · ISO · Materials
Key facts
| Recognition number | 8-593 |
|---|---|
| Designation | 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 |
| Title | Implants for surgery - Hydroxyapatite - Part 6: Powders |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 13779-6:2015 specifies requirements for hydroxyapatite powders used as a raw material for the manufacturing of surgical implants or coating of surgical implants. ISO 13779-6:2015 does not apply to hydroxyapatite coatings, ceramic hydroxyapatite, glass ceramics, alpha-945 and beta-946 tricalcium… |
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: