What are the specific requirements of EN 12183 and EN 12184 for wheelchairs?
Specific requirements of EN 12183 and EN 12184 for wheelchairs
In the EU market, wheelchairs and mobility scooters, as medical devices, need to meet strict EU standards to ensure product safety and reliability. EN 12183 and EN 12184 are two key European standards for manual wheelchairs and electric wheelchairs and mobility scooters, respectively. This article will introduce the specific requirements of these two standards for wheelchairs in detail.
1. Requirements of EN 12183 for manual wheelchairs
1. Scope of application
EN 12183:2014 standard applies to manual wheelchairs with a load capacity of no more than 250 kg, including manual wheelchairs with electric assistive devices.
2. Safety performance
Stability: Manual wheelchairs must have sufficient stability to prevent tipping during use. Test methods include static and dynamic stability tests.
Strength: The seat and back support must be able to withstand the user’s weight and remain stable during long-term use. Test items include the strength and stability of the seat and back support.
Braking system: The braking system must be reliable to ensure that the user can park safely when needed. The requirements of the braking system include:
It can still operate when the battery is not powered by the drive system.
It can still operate when the wheelchair is in freewheel mode.
If the parking brake is worn, adjustments and replacements specified by the manufacturer must be provided.
The brake mechanism cannot move from the preset position, and the parts and accessories of the components cannot be deformed.
3. Ergonomics
Seat and back support: It must comply with ergonomic principles to ensure the comfort and health of the user. The design of the seat and back support should take into account the user’s sitting posture and support needs.
Ease of operation: The wheelchair should be easy to operate and the user can easily push and control it. Including the design and location of the handle, as well as the steering performance of the wheelchair.
4. Durability
Durability testing: Manual wheelchairs must undergo rigorous durability testing to ensure their reliability and stability in long-term use. Test items include static and dynamic tests, simulating various situations during the use of the wheelchair.
Service life: The various components of the wheelchair should have sufficient durability to ensure the service life under normal use conditions. Including the durability of components such as wheels, bearings, and brake systems.
5. Labeling and instructions
Labeling: The wheelchair model, manufacturer, instructions for use, maintenance instructions, and other information must be clearly labeled to ensure that users can use and maintain the wheelchair correctly.
Instructions for use: Detailed instructions for use must be provided, including operating methods, maintenance, safety precautions, etc.
II. Requirements of the EN 12184 standard for electric wheelchairs and mobility scooters
1. Scope of application
The EN 12184:2014 standard applies to electric wheelchairs and mobility scooters with a maximum speed of no more than 15 km/h and used to carry one and a load of no more than 300 kg.
2. Safety performance
Mechanical strength:
Static, impact and fatigue strength: Electric wheelchairs must undergo static, impact and fatigue strength tests to ensure their structural strength during use.
Dynamic stability: Electric wheelchairs must have good dynamic stability to prevent tipping during driving. The test method includes dynamic stability testing.
Braking system:
Braking performance: The braking system must be reliable to ensure that users can stop safely when needed. Requirements for the brake system include:
Operation when the battery is not supplying power to the drive system.
Operation when the wheelchair is in freewheel mode.
If the parking brake is worn, adjustments and replacements specified by the manufacturer must be provided.
The brake mechanism must not move from the preset position, and the components and accessories must not deform.
Brake lever design: The design and operation requirements of the brake lever include:
If the brake lever is equipped with a conventional ball knob, the force must be applied through the center of the knob.
If the brake lever is parallel or any other shape than the above, the force must be applied through a point on the center line of the brake lever 15mm from the top.
If the brake lever is controlled by the entire armrest, the force must be applied through the center line of the brake lever 15mm from the bottom.
If the brake is applied by pushing or pulling on a bar or pad, the force must be applied to the center of mass of the bar or pad.
Electrical safety:
Circuit protection: The circuits of the electric wheelchair must be protected against excessive current. When the protection circuit method is operated, the driving, braking and steering functions must not be affected.
Battery charger: The battery charger must meet the following requirements:
The battery charger shall indicate when charging and when charging is complete.
The battery charger shall have the ability to discharge to 70% of the normal voltage.
The battery charger shall operate without intervention or supervision whether it is disconnected, turned on when charging begins, and turned off and disconnected when charging is completed.
3. Electromagnetic compatibility (EMC)
Electromagnetic interference: The electric wheelchair must meet the electromagnetic compatibility requirements to ensure that it will not interfere with other electronic devices during use, nor will it be interfered with by other electronic devices. The test method includes electromagnetic interference testing.
4. Ergonomics
Seat and back support: It must comply with ergonomic principles to ensure the comfort and health of the user. The design of the seat and back support should take into account the user’s sitting posture and support needs.
Ease of operation: The electric wheelchair should be easy to operate and the user should be able to control it easily. This includes the design and location of the controls, as well as the steering performance of the wheelchair.
5. Durability
Durability testing: The electric wheelchair must undergo rigorous durability testing to ensure its reliability and stability in long-term use. The test items include static and dynamic tests, simulating various situations during the use of the wheelchair.
Service life: Each component of the wheelchair should have sufficient durability to ensure its service life under normal use conditions. Including the durability of components such as wheels, bearings, and brake systems.
6. Labeling and instructions
Labeling: The model, manufacturer, instructions for use, maintenance instructions and other information of the wheelchair must be clearly marked to ensure that the user can use and maintain the wheelchair correctly.
Instructions for use: Detailed instructions for use must be provided, including operating methods, maintenance, safety precautions, etc.
III. Summary
EN 12183 and EN 12184 standards have strict requirements on the safety, ergonomics, durability and labeling of wheelchairs. These standards ensure the safety and reliability of wheelchairs during use and protect the safety and health of users. Manufacturers must strictly comply with these standards and conduct necessary tests and certifications to ensure that their products meet the requirements of the EU market.
Post time: Jan-15-2025