| ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 16-190 |
| 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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ISO 7176-11:2012 specifies requirements for test dummies of any mass greater than or equal to 25 kg, to be used in the evaluation of wheelchairs. ISO 7176-11:2012 provides formulae that specify the location of the overall centre of mass of test dummies, the masses of the segments that comprise the test dummies and the locations of pivots that connect the segments. It also specifies the characteristics of loading pads that support the segments.
ISO 7176-11:2012 is intended to enable the construction of test dummies that will produce comparable results for stability, performance and durability testing of manual wheelchairs and electrically powered wheelchairs, including scooters.
ISO 7176-11:2012 also includes informative tables of mass and locations of centre of mass, which are derived from the formulae, corresponding to example test dummy masses up to 300 kg in 25 kg increments.
| 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 |
| There is no relevant guidance developed at this time. |