Recognized standard
/TS 10993-19 Second edition 2020-03
FDA recognition 2-281 · ISO · Biocompatibility
Key facts
| Recognition number | 2-281 |
|---|---|
| Designation | /TS 10993-19 Second edition 2020-03 |
| Title | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those… |
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: