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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 08/06/2013 
FR Recognition Number 16-191
Standard
ISO 7176-16 Second edition 2012-12-01
Wheelchairs - Part 16: Resistance to ignition of postural support devices
Scope/Abstract
ISO 7176-16:2012 specifies requirements and test methods to assess the resistance to ignition by match flame equivalent of all postural support devices that are supplied to be part of a wheelchair or its seating system.

ISO 7176-16:2012 only determines the resistance to ignition of the devices tested and not the ignitability of the complete wheelchair.

ISO 7176-16:2012 allows for the separate testing of inferior/superior supports (e.g. arm supports), which are usually used in the horizontal plane, and anterior/posterior/lateral/medial supports (e.g. thoracic harnesses, calf panels), which are usually used in the vertical plane.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
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
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Kathryn Delaurentis
  FDA/OMPT/CDRH/ODE/DNPMD/PMDB/
  240-402-4911
  kathryn.delaurentis@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
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