|FR Publication Date: 01/30/2014
Part B: Supplementary Information
ANSI / RESNA WC/Volume 2 - 1998, section 14: wheelchairs - testing of power and control systems for electric wheelchairs. (Physical Medicine)
|Addresses of Standards Development Organizations:|
| American National Standards Institute (ANSI)|
| 25 West 43rd Street|
| 4th Floor|
| New York, NY 10036 |
| Rehabilitation Engineering and Assistive Technology Society of North America (RESNA)|
| 1700 N. Moore Street|
| Suite 1540|
| Arlington, VA 22209-1903 |
|CDRH Office and Division associated with recognized standards:|
|OFFICE OF DEVICE EVALUATION (ODE) |
|Powered Wheelchairs and Motorized 3-Wheeled Vehicles (Scooters)|
|Processes Affected: |
|510(K), IDE, PMA, PDP, Design Controls|
|Type of Standard:|
| Test Methods, National, Vertical|
|Extent of Recognition:|
Standard specifies the requirements for the power and control systems of electrically powered wheelchairs, including battery chargers, and associated test methods.
If the specified maximum capacity of the device is greater than 100 kg, a custom-designed test dummy should be used to complete this test. The design of the test dummy should follow the guidelines provided in ANSI/RESNA WC Volume 1 - 1998, Section 11 (Test Dummies).
Manufacturers should disclose the results of the testing in the product labeling.
Manufacturers should also document that the ground leakage current for the battery charger does not exceed 100 u Amp (ANSI/AAMI ES 1:1993 Safe Current Limits for Electromedical Apparatus).
|Related CFR Citations and Product Codes:|
|FDA Technical Contact:|
| Laurence Coyne |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1526 |
| Silver Spring MD 20993 |
| 301/796-5650 |
| email: firstname.lastname@example.org|