Recognized standard
/TS 37137-1 First edition 2021-03
FDA recognition 2-290 · ISO · Biocompatibility
Key facts
| Recognition number | 2-290 |
|---|---|
| Designation | /TS 37137-1 First edition 2021-03 |
| Title | Biological evaluation of absorbable medical devices - Part 1: General requirements. |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jun 7, 2021 |
| Scope (excerpt) | This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A). |
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: