Recognized standard
10993-16 Third edition 2017-05
FDA recognition 2-249 · ISO · Biocompatibility
Key facts
| Recognition number | 2-249 |
|---|---|
| Designation | 10993-16 Third edition 2017-05 |
| Title | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jun 7, 2018 |
| Scope (excerpt) | This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices. |
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: