Recognized standard
14630 Fourth edition 2012-12-01
FDA recognition 11-254 · ISO · Orthopedic
Key facts
| Recognition number | 11-254 |
|---|---|
| Designation | 14630 Fourth edition 2012-12-01 |
| Title | Non-active surgical implants -- General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and… |
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: