ISO 7176-14 Second edition 2008-02-15

Standard Organization:

ISO 7176-14 Second edition 2008-02-15
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods

Recognition Date2014-01-30
Recognition List034
Recognition Number16-165
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Physical Medicine
FDA Tech  John Marszalek   FDA/OMPT/CDRH/OC/DICO/FEB/   301-796-7067   john.marszalek@fda.hhs.gov

Rationale:

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Scope:

ISO 7176-14:2008 specifies requirements and associated test methods for the power and control systems of electrically powered wheelchairs and scooters. It sets safety and performance requirements that apply during normal use and some conditions of abuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and sets limits on the forces needed for some operations.

ISO 7176-14:2008 is applicable to electrically powered wheelchairs and scooters with a maximum speed no greater than 15 km/h intended to provide indoor and/or outdoor mobility for one disabled person whose mass lies in the range specified in ISO 7176-11.

Code of Federal Regulations:

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 Wheelchair, Mechanical Class 1 IOR
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI

FDA Guidance:

There is no relevant guidance at this time.

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