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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 060 Date of Entry 05/29/2023 
FR Recognition Number 16-235
Standard
ISO  7176-25 Second Edition 2022
Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
Scope/Abstract
This document specifies requirements and test methods for lead-acid batteries and their chargers intended for use with electrically-powered wheelchairs and scooters. Requirements for chargers are applicable to those with a rated input voltage not greater than 250 V AC and a nominal output voltage not greater than 36 V.
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FDA recognition of ISO 7176-25 First edition 2013-07-15 [Rec# 16-194] will be superseded by recognition of ISO 7176-25 Second Edition 2022 [Rec# 16-235]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-194] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 16-194] 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
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
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
 Amir Razjouyan
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-2701
  Amir.Razjouyan@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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