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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 031 Date of Entry 08/06/2013 
FR Recognition Number 16-190
Standard
ISO  7176-11 Second edition 2012-12-01
Wheelchairs - Part 11: Test dummies
Scope/Abstract
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.
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*
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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