Recognized standard
TS 17137 Third edition 2021-09
FDA recognition 8-590 · ISO · Materials
Key facts
| Recognition number | 8-590 |
|---|---|
| Designation | TS 17137 Third edition 2021-09 |
| Title | Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | May 30, 2022 |
| Scope (excerpt) | This document establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is intended to supplement device-specific… |
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: