Recognized standard
F1441-03 (Reapproved 2014)
FDA recognition 6-110 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-110 |
|---|---|
| Designation | F1441-03 (Reapproved 2014) |
| Title | Standard Specification for Soft-Tissue Expander Devices |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | 1.1 This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. 1.2 Limitations: 1.2.1 This specification applies only to soft-tissue expander… |
At a glance
- 1–9 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: