Recognized standard
7206-13 First edition 2016-07-01 [Including AMD1:2022]
FDA recognition 11-396 · ISO · Orthopedic
Key facts
| Recognition number | 11-396 |
|---|---|
| Designation | 7206-13 First edition 2016-07-01 [Including AMD1:2022] |
| Title | Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 7206 describes a method of determining the torque required, under specified laboratory conditions, to loosen the fixation of the head of hip joint prostheses in which the head is not intended to rotate relative to the neck. It applies to the femoral component of total or partial hip… |
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: