Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

052

Date of Entry 07/15/2019

FR Recognition Number

16-206

Standard

ISO 7176 - 30 First edition 2018-12
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements

Scope/Abstract

This document specifies the test methods and requirements for determining the safety and performance of a manual and/or power wheelchair that incorporates technology to alter the posture of the wheelchair occupant, which are either electrically or manually operated by the occupant or assistant during normal wheelchair use. This can include recline, tilt, elevate and stand-up mechanisms or a combination of these. In order for a wheelchair to be able to recline, tilt, elevate and/or stand-up, the wheelchair requires additional mechanisms and mechanical structures to allow these features to operate. This document specifies the different functional and strength tests required to test these wheelchairs in critical configurations of their adjustable range.
This document does not cover wheelchairs where the only operator adjustable body support system (OABSS) is adjustable limb or head postural support devices alone (e.g. elevating leg supports).
This document does not include wheelchair and postural support device customization during initial or subsequent setup of a wheelchair for an individual occupant. It also does not reflect other factors that can influence wheelchair stability such as occupant movement, cushion thickness, and the addition of ancillary equipment (e.g. respiratory support items).

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.

NOTE: For questions regarding the testing positions, the manufacturer should contact the review team to address testing positions prior to submission.

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

Relevant FDA Guidance and/or Supportive Publications*

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.

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 Contacts

Angela DeMarco

FDA/OC/CDRH/OPEQ/ORP/DRPI/

301-796-4471

Angela.Demarco@fda.hhs.gov

Kathryn Delaurentis

FDA/OC/CDRH/OPEQ/OHTV/DHTVB/

240-402-4911

kathryn.delaurentis@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization