|Recognition List Number: 026 FR Publication Date: 03/18/2011
Part B: Supplementary Information
Recognition Number 16-185: ANSI / RESNA WC-2:2009, section 21: requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and. (Physical Medicine)
Date of Standard: 2008.
|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 scooters|
|Processes Affected: |
|510(k), PMA, IDE, PDP, HDE, Design Controls|
|Type of Standard:|
| Vertical, National|
|Extent of Recognition:|
|Complete Standard, except for Clause 9.2.1 Wheelchairs power and control systems, which states "For the requirements of Clause 188.8.131.52 (brake release), adjust the wheelchair in accordance with Clause 6.1.5." because it cites a nonexistent clause (184.108.40.206).
This standard should serve as a baseline to address electromagnetic compatibility (EMC) for the powered wheelchairs and motorized scooter devices. However, where there are existing CDRH guidance documents with additional EMC specifications then these will supersede the basic ANSI/RESNA EMC requirements.
Where there are existing CDRH guidance documents and recommendations regarding EMC specifications these supersede the ANSI/RESNA requirements.
Any declaration of conformance to the EMC aspects of this ANSI/RESNA standard should be accompanied by the following documentation:
1) a summary of the testing that was done including the test method used (i.e., Anechoic chamber or GTEM);
2) the requirements of the standard that were met (including immunity test levels);
3) the pass/fail criteria used;
4) the performance of the device during each immunity test (i.e., degradation observed);
5) identification of and justification for any of the standard's allowances that were used;
6) a description of and justification for any deviations from the requirements of the standard;
7) evidence of compliance with the standard's labeling (identification, marking and documents) requirements; and
8) if any device modifications were needed in order to pass any of the EMC testing, a description of these modifications and a statement that they will all be incorporated into the production units.
EMC testing standards referenced in this ANSI/RESNA standard are appropriate for use as part of good manufacturing practices (GMP). For the control of electrostatic discharge in production, handling and storage of medical devices, seeANSI/ESD S20.20-2007 For the Development of an Electrostatic Discharge Control Program for - Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) .
We recommend the radiated immunity test level of 20 V/m be used for all wheelchair and scooter immunity tests.
|Related CFR Citations and Product Codes:|
|Relevant Guidance: |
|"Guidance Document for the Preparation Of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs And Motorized Three Wheeled Vehicles" July 26, 1995 (reformatted 12/18/97).
"Letter To Powered Wheelchair/Scooter Or Accessory/Component Manufacturers, May 26, 1994"
Additional general information on medical device EMC can be found in guidance documents on EMC in the following device areas: Respiratory and Anesthesia Devices, Ventilators, Apnea Monitors, Powered Wheelchairs and Motorized Scooters, Cardiac Pacemakers, and Implantable Defibrillators. These and any other guidance documents with additional EMC requirements should be utilized.
|FDA Technical Contact:|
| Donald Witters |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 1130 |
| Silver Spring MD 20993 |
| 301/796-2483 |
| email: email@example.com|