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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 058 Date of Entry 05/30/2022 
FR Recognition Number 16-166
Standard
ISO  7176-21 Second edition 2009-04-01
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
Scope/Abstract
ISO 7176-21:2009 specifies requirements and test methods for electromagnetic emissions and for electromagnetic immunity of electrically powered wheelchairs and scooters with a maximum speed of not more than 15 km/h intended for indoor and/or outdoor use by people with disabilities. It is also applicable to manual wheelchairs with an add-on power kit. It is not applicable to vehicles designed to carry more than one person.

ISO 7176-21:2009 also specifies requirements and test methods for the electromagnetic compatibility of battery chargers intended for use with electrically powered wheelchairs and scooters.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 5.2.2 Electrostatic discharge immunity
Clause 5.2.3 Radiated r.f. field immunity
Clause 5.2.4 Power frequency magnetic field immunity
Clause 5.3.5 Electrostatic discharge immunity
Clause 5.3.6 Radiated r.f. field immunity
Clause 5.4.5 Electrostatic discharge immunity
Clause 5.4.6 Radiated r.f. field immunity
Rationale for Recognition
This standard is recognized in part because:
Clause 5.2.2, Clause 5.2.3, Clause 5.2.4, Clause 5.3.5, Clause 5.3.6, Clause 5.4.5, and Clause 5.4.6 are in conflict with another recognized standard, see references #1 and #2 listed below.
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
§890.3860 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*
1. IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition Number: 19-36).
2. ANSI RESNA WC-2:2019 Section 21; American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters (Recognition Number: 16-224).


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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