Recognized standard
8828 Second edition 2014-11-15
FDA recognition 11-290 · ISO · Orthopedic
Key facts
| Recognition number | 11-290 |
|---|---|
| Designation | 8828 Second edition 2014-11-15 |
| Title | Implants for surgery -- Guidance on care and handling of orthopaedic implants |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | This International Standard specifies the recommended procedures for handling orthopaedic implants, hereafter referred to as implants, from receipt at the hospital until they are implanted or discarded. This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants)… |
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: