Recognized standard
F2392-04 (Reapproved 2015)
FDA recognition 8-135 · ASTM · Materials
Key facts
| Recognition number | 8-135 |
|---|---|
| Designation | F2392-04 (Reapproved 2015) |
| Title | Standard Test Method for Burst Strength of Surgical Sealants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | 1.1 This test method provides a means for comparison of the burst or rupture strength of sealants on soft tissue. This test method can be used as a clinically relevant model for quality assurance, development, and comparative testing of different adhesives or adherends. 1.2 This test method measures… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: