Recognized standard
F2458-05 (Reapproved 2015)
FDA recognition 8-136 · ASTM · Materials
Key facts
| Recognition number | 8-136 |
|---|---|
| Designation | F2458-05 (Reapproved 2015) |
| Title | Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | 1.1 This test method covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of medical devices used as tissue… |
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: