Recognized standard
15309 First edition 2013-12-01
FDA recognition 8-389 · ISO · Materials
Key facts
| Recognition number | 8-389 |
|---|---|
| Designation | 15309 First edition 2013-12-01 |
| Title | Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | This International Standard specifies a method for the thermal analysis of Poly Ether Ether Ketone (PEEK) that is for use in the manufacture of implantable medical devices, using differential scanning calorimetry (DSC). The transition temperatures to be determined are the glass transition… |
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: