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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 16-197
Standard
ISO  7176-8 Second editon 2014-12-15
Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
Scope/Abstract
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.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Angela DeMarco
  FDA/OC/CDRH/OPEQ/ORP/DRPI/
  301-796-4471
  Angela.Demarco@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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