ISO 7176-25 First edition 2013-07-15

Standard Organization:

ISO 7176-25 First edition 2013-07-15
Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs

Recognition Date2015-08-14
Recognition List040
Recognition Number16-194
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 7176-25:2013 specifies requirements and test methods for batteries and battery chargers intended for use with electrically powered wheelchairs. It is applicable to lead acid batteries and chargers intended for use with them. Requirements for chargers are applicable to those with a rated input voltage not greater than 250 V a.c. and a nominal output voltage not greater than 36 V.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL

FDA Guidance:

There is no relevant guidance developed at this time.


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