Recognized standard
F565-04 (Reapproved 2018)
FDA recognition 11-199 · ASTM · Orthopedic
Key facts
| Recognition number | 11-199 |
|---|---|
| Designation | F565-04 (Reapproved 2018) |
| Title | Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 1, Class 2, Class 3 |
| Scope (excerpt) | 1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments. 1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel… |
At a glance
- 100–999 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: