Recognized standard
10328 Second edition 2016-06-01
FDA recognition 16-231 · ISO · Physical Medicine
Key facts
| Recognition number | 16-231 |
|---|---|
| Designation | 10328 Second edition 2016-06-01 |
| Title | Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Physical Medicine |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | IMPORTANT This International Standard is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their… |
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: