Recognized standard
7206-12 First edition 2016-10-01
FDA recognition 11-319 · ISO · Orthopedic
Key facts
| Recognition number | 11-319 |
|---|---|
| Designation | 7206-12 First edition 2016-10-01 |
| Title | Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 7206 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are… |
At a glance
- 10–99 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: