Standards Library

One Standards Map. Three Markets.

A consolidated reference of every standard we test wheelchairs and mobility aids against — for FDA, CE, and NMPA routes.

ISO 7176 Series — The Global Backbone

ISO 7176 is the most widely adopted wheelchair standard family. We run all 28 parts in-house.

ISO 7176-1
Static Stability
ISO 7176-2
Dynamic Stability
ISO 7176-3
Braking Effectiveness
ISO 7176-4
Energy Consumption / Range
ISO 7176-5
Dimensions / Mass / Maneuvering
ISO 7176-7
Seating / Wheel Dimensions
ISO 7176-8
Static / Impact / Fatigue
ISO 7176-9
Climatic Test
ISO 7176-10
Obstacle Climbing
ISO 7176-13
Friction of Test Surfaces
ISO 7176-14
Power & Control Systems
ISO 7176-15
Information Disclosure
ISO 7176-16
Flammability Resistance
ISO 7176-19
Wheelchairs Used as Seats in Motor Vehicles
ISO 7176-21
EMC Requirements & Test Methods
ISO 7176-22
Set-Up Procedures
ISO 7176-25
Batteries & Chargers
ISO 7176-28
Stair-Climbing Devices

US Market — FDA 510(K)

Powered wheelchairs are Class II devices. We've coached 36 cleared 510(K) submissions since 2022.

21 CFR 890.3850
Mechanical Wheelchair
21 CFR 890.3860
Motorized Wheelchair
ANSI/RESNA WC-1
Wheelchair Test Methods
ANSI/RESNA WC-2
Additional Test Methods
ANSI/RESNA WC-3
Wheelchair Tiedown
FCC Part 15
EMC for Electronic Devices
UL 2271
Light Electric Vehicle Batteries
ASTM F1825
Walker / Rollator

EU Market — CE-MDR

Most wheelchairs are Class I (manual) or Class IIa (powered) under MDR.

EU MDR 2017/745
Medical Device Regulation
EN 12182
Assistive Products — General
EN 12183
Manual Wheelchairs
EN 12184
Electrically Powered Wheelchairs
EN 1986-1
Wheelchair Energy / Range
ISO 11334-1
Crutches
ISO 11334-4
Walking Sticks

China Market — NMPA

Wheelchairs are Class II medical devices under NMPA. GB standards align closely with ISO 7176.

GB/T 18029
Wheelchair — GB equivalent of ISO 7176
YY/T 0641
Wheelchair General Requirements
GB 9706.1
Medical Electrical Safety
YY 0505
Medical Electrical EMC

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