Recognized standard
F1185-03 (Reapproved 2014)
FDA recognition 8-427 · ASTM · Materials
Key facts
| Recognition number | 8-427 |
|---|---|
| Designation | F1185-03 (Reapproved 2014) |
| Title | Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.) 1.2 The biological response to hydroxylapatite in soft tissue and bone… |
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: