Recognized standard
7176-8 Second editon 2014-12-15
FDA recognition 16-197 · ISO · Physical Medicine
Key facts
| Recognition number | 16-197 |
|---|---|
| Designation | 7176-8 Second editon 2014-12-15 |
| Title | Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
| Standards developer | International Organization for Standardization |
| Specialty area | Physical Medicine |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This part of ISO 7176 specifies requirements for static, impact and fatigue strength of wheelchairs including scooters intended for users whose mass does not exceed 100 kg. It specifies the test methods for determining whether the requirements have been met. It also specifies requirements for… |
At a glance
- 1–9 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: