Recognized Consensus Standards

Recognition List Number: 023 Publication Date: 05/05/2010

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 16-165: ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods. (Physical Medicine)

Date of Standard: 2008.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Mechanical and Powered Wheelchairs

Processes Affected:

510(k), IDE, PMA, PDP

Type of Standard:

Test Methods, International, Vertical

Extent of Recognition:

Complete Standard.

Standard covers functional dimensions and test method considerations for the characterization and comparison of mechanical and powered wheelchairs. Additional information must be provided to document that the design of the product will provide adequate mechanical and electrical properties for the particular application.

Where there are existing CDRH guidance documents and recommendations regarding EMC specifications these supersede the ISO requirements.

Any declaration of conformance to the EMC aspects of this ISO 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 an 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.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§890.3800	Vehicle, Motorized 3-Wheeled	Class 2	INI

Regulation Number	Device Name	Device Class	Product Code
§890.3850	Wheelchair, Mechanical	Class 1	IOR

Regulation Number	Device Name	Device Class	Product Code
§890.3860	Wheelchair, Powered	Class 2	ITI

Regulation Number	Device Name	Device Class	Product Code
§890.3880	Wheelchair, Special Grade	Class 2	IQC

Regulation Number	Device Name	Device Class	Product Code
§890.3890	Wheelchair, Stair Climbing	Class 3	IMK

Regulation Number	Device Name	Device Class	Product Code
§890.3900	Wheelchair, Standup	Class 2	IPL

Regulation Number	Device Name	Device Class	Product Code
§890.3930	Elevator, Wheelchair, Portable	Class 2	ING