Recognized standard
10993-18 Second edition 2020-01 Amendment 1 2022-05
FDA recognition 2-298 · ISO · Biocompatibility
Key facts
| Recognition number | 2-298 |
|---|---|
| Designation | 10993-18 Second edition 2020-01 Amendment 1 2022-05 |
| Title | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]. |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Sep 7, 2026 |
| Scope (excerpt) | This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to… |
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: