Recognized standard
F116-12 (Reapproved 2016)
FDA recognition 11-309 · ASTM · Orthopedic
Key facts
| Recognition number | 11-309 |
|---|---|
| Designation | F116-12 (Reapproved 2016) |
| Title | Standard Specification for Medical Screwdriver Bits |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants. 1.2 This specification is based, in part, upon ISO 8319-1, ISO 8319-2, and ISO 10664. 1.3 The screwdrivers with the bits described in this… |
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: