| ISO 7176-8 Second editon 2014-12-15 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 16-197 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Physical Medicine |
| FDA Tech | Angela DeMarco FDA/OMPT/CDRH/ODE/POS/510(K)/ 301-796-4471 angela.demarco@fda.hhs.gov |
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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 disclosure of the test results.
The test methods may also be used to verify manufacturers' claims that a product exceeds the minimum requirements of this part of ISO 7176.
A reference configuration is specified for adjustable wheelchairs and scooters to enable test results to be used for the comparison of performance.
It applies to occupant- and attendant-propelled manual wheelchairs and electrically powered wheelchairs intended to provide indoor and outdoor mobility for people with disabilities. For electrically powered wheelchairs, it applies to those with a maximum speed of not more than 15 km/h where not more than two wheels are driven and which have three or more wheels located on two parallel, transverse axes.
The application of this part of ISO 7176 is limited to wheelchairs with a maximum occupant mass of 100 kg because this is the maximum mass of test dummy available in ISO 7176-11. Further work is needed to investigate the effects of the lifestyle of people with larger body masses.
| Regulation Number | Device Name | Device Class | Product Code |
| §890.3930 | Elevator, Wheelchair, Portable | Class 2 | ING |
| §890.3900 | Wheelchair, Standup | Class 2 | IPL |
| §890.3890 | Wheelchair, Stair Climbing | Class 2 | IMK |
| §890.3880 | Wheelchair, Special Grade | Class 2 | IQC |
| §890.3860 | Wheelchair, Powered | Class 2 | ITI |
| §890.3850 | Stroller, Adaptive | Class 1 | LBE |
| §890.3850 | Wheelchair, Mechanical | Class 1 | IOR |
| §890.3800 | Vehicle, Motorized 3-Wheeled | Class 2 | INI |
| §890.3850 | Stroller, Adaptive | Class 1 | LBE |
| §890.3850 | Stroller, Adaptive | Class 1 | LBE |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995. |