Recognized standard
13781 Second edition 2017-07
FDA recognition 8-479 · ISO · Materials
Key facts
| Recognition number | 8-479 |
|---|---|
| Designation | 13781 Second edition 2017-07 |
| Title | Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This document describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under in vitro degradation testing conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric… |
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: