EN 12184

Safety Requirements of Wheelchairs for CE Mark in EU Market

Medical Devices Regulation

European Union Medical Devices Regulation (MDR) and Applicable Standards

The European Union Medical Devices Regulation (MDR, Regulation (EU) 2017/745) entered into force on 25 May 2017 and became fully applicable on 26 May 2021. The MDR was established to replace the previous Medical Devices Directive (MDD), strengthening the regulatory framework for medical devices within the European market.

In line with the essential requirements of MDR 2017/745, electric wheelchairs are required to comply with the latest edition of EN 12184 (2022). This standard sets out performance requirements and safety testing for electric wheelchairs and mobility scooters, ensuring their conformity with European regulatory expectations.

Under the MDR, manual wheelchairs, electric wheelchairs, and mobility scooters are classified as Class I medical devices. Compliance obligations include the preparation of technical documentation, risk management files, biocompatibility reports, and flammability test results. Furthermore, all products must bear the CE marking as evidence of conformity.

The corresponding international standards applicable to manual wheelchairs, electric wheelchairs, and mobility scooters are outlined as follows:

EN 12183 Manual wheelchairs - Requirements and test methods
EN 12184 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
ISO 7176 Wheelchairs and scooters, standard requirements and test methods.
EN 12184:2022 Electrically powered wheelchairs and scooters standard requirements

Standard requirements include: Electrically powered wheelchairs, Tricycle or Electric Mobility Scooter with Multiple Wheels and battery charger.

Applicable Products: Wheelchairs and mobility scooters with a maximum speed not exceeding 20 km/h, designed for a single occupant, and with a total weight not exceeding 300 kg. The classification of wheelchairs and mobility scooters under EN 12184 is shown in the table below:

Table

Characteristics	Requirements
	Class A	Class B	Class C
Rated Gradient	3°	6°	10°
Dynamic stability	3°	6°	10°
Static stability	6°	9°	15°
Parking Brake Performance	6°	9	15°
Maximum speed
- moves forward	15 km/h	20 km/h	20 km/h
- reverse	70 % of maximum forward speed or 5 km/h whichever is lower	70 % of maximum forward speed or 5 km/h whichever is lower	70 % of maximum forward speed or 5 km/h whichever is lower
Climb ability	15 mm	50 mm	100 mm
Theoretical Travel Distance	15 km	25 km	35 km
Ground Clearance for Uneven Surfaces	10 mm	30 mm	50 mm

Safety Requirements and Test Methods under EN 12184

The safety requirements for wheelchair design inputs under EN 12184 include:

Biocompatibility specifications and toxicity requirements
Component operational safety and risk management requirements
Clinical evaluation, ergonomics, and usability
Measures to prevent entrapment or injury to human body parts

In addition, EN 12184 references a number of test methods derived from the ISO 7176 series, such as:

ISO 7176-1 Determination of static stability
ISO 7176-2 Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3 Determination of effectiveness of brakes
ISO 7176-4 Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-6 Determination of maximum speed of electrically powered wheelchairs
ISO 7176-8 Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9 Climatic tests for electric wheelchairs
ISO 7176-10 Determination of obstacle-climbing ability of electrically powered wheelchairs
IS0 7176-11 Test dummies
IS0 7176-13 Determination of coefficient of friction of test surfaces
ISO 7176-14 Power and control systems for electrically powered wheelchairs and scooters — Requirements and test methods
ISO 7176-15 Requirements for information disclosure, documentation and labelling
ISO 7176-19 Wheelchairs intended for use as seats in transportation vehicles
ISO 7176-21 Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22 Set-up procedures