Recognized standard
10993-1 Fifth edition 2018-08 10993-1: 2018
FDA recognition 2-258 · ISO · Biocompatibility
Key facts
| Recognition number | 2-258 |
|---|---|
| Designation | 10993-1 Fifth edition 2018-08 10993-1: 2018 |
| Title | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | This document specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of medical devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from… |
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: