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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 16-191
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
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 7176-16 Second edition 2012-12-01 [Rec# 16-191] will be superseded by recognition of ISO 16840-10: Second Edition 2021 Corrected version 2022-01 [Rec# 16-233]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-191] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 16-191] will not be accepted.
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
 Kathryn Delaurentis
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  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
*These are provided as examples and others may be applicable.
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