Recognized standard
F881-94 (Reapproved 2014)
FDA recognition 6-185 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-185 |
|---|---|
| Designation | F881-94 (Reapproved 2014) |
| Title | Standard Specification for Silicone Elastomer Facial Implants |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants). 1.2 Limitations-This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any… |
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: