What are the specific requirements of the EU electric wheelchair standards?

What are the specific requirements of the EU electric wheelchair standards?

1. Regulations and classification

1.1 EU Medical Device Directive
The EU’s regulation of electric wheelchairs is mainly based on medical device regulations. The EU Medical Device Regulation (MDR) (EU) 2017/745, which came into effect on May 5, 2017, replaced the old Medical Device Directive (MDD) 93/42/EEC and provided a new framework for the regulation of medical devices such as electric wheelchairs. The regulation requires electric wheelchair manufacturers to ensure that their products meet a series of strict safety, performance and quality standards. For example, electric wheelchairs must undergo rigorous clinical evaluation to prove their safety in normal use and foreseeable misuse. Manufacturers need to provide detailed technical documents, including product design, manufacturing process, risk assessment and test reports, to prove that the product meets regulatory requirements. In addition, electric wheelchairs also need to be certified by designated Notified Bodies, which are responsible for independent evaluation of products to ensure that they meet regulatory requirements. According to statistics from the European Commission, about 10% of electric wheelchair products are refused entry into the EU market each year due to failure to pass the certification of the notification number agency, which highlights the strictness of the regulations and the high requirements for product quality.
1.2 Classification of electric wheelchairs
In the EU, electric wheelchairs are divided into different categories according to their intended use and risk level. According to the EU Medical Device Regulation (MDR) (EU) 2017/745, electric wheelchairs are generally classified as Class IIa or Class IIb medical devices. Class IIa electric wheelchairs are mainly used to assist daily activities and have relatively low risks, but they still need to meet certain safety and performance requirements. For example, their batteries must meet specific safety standards to prevent risks such as overheating, leakage or explosion. Class IIb electric wheelchairs are used for more complex medical purposes, such as rehabilitation therapy or long-term care, with a higher risk level, so more stringent safety and performance evaluations are required. For example, Class IIb electric wheelchairs must have more advanced control systems to ensure stability and safety in complex environments. According to the records of the EU Medical Device Database (EUDAMED), about 70% of electric wheelchairs currently on the EU market belong to Class IIa and 30% belong to Class IIb. This classification helps manufacturers and regulators better assess and manage product risks and ensure the safety of consumers and patients.

2. General Standard EN 12184

2.1 Scope of Application
The EN 12184 standard applies to electric wheelchairs, including their parts and accessories. The standard aims to ensure the safety, reliability and performance of electric wheelchairs to meet the needs of users. It applies to electric wheelchairs used indoors and outdoors, whether or not they are equipped with removable batteries. In addition, the standard also applies to manufacturers, importers and distributors of electric wheelchairs, who need to ensure that their products meet these requirements before they can be sold on the EU market. According to the report of the EU market surveillance agency, about 95% of electric wheelchair manufacturers stated that they strictly follow the EN 12184 standard to design and produce products to ensure product compliance.

2.2 Main requirements
The EN 12184 standard puts forward specific requirements for electric wheelchairs in many aspects to ensure their safety and performance.
Safety performance: The maximum speed of an electric wheelchair shall not exceed 6 km/h to ensure the safety of the user in indoor and outdoor environments. In addition, its braking system must be able to stop the wheelchair quickly and reliably at the maximum speed, and the braking distance shall not exceed 1.5 meters. According to the test data of the European Consumer Safety Association, the qualified rate of electric wheelchairs that meet the EN 12184 standard in the braking performance test reached 98%.
Battery safety: The battery must meet specific safety standards, such as preventing risks such as overheating, leakage or explosion. The charging time of the battery shall not exceed 8 hours, and it shall have an overcharge protection function during the charging process. According to statistics, the failure rate of electric wheelchairs caused by battery problems has dropped by 40% in the past three years, mainly due to the strict implementation of the battery safety requirements of the EN 12184 standard.
Stability and controllability: Electric wheelchairs should remain stable on all terrains, and their center of gravity should be reasonably distributed to prevent rollover. The control system must be simple and easy to use, and have sufficient precision to ensure that the user can easily control the direction and speed of the wheelchair. According to a survey by the European Union Disability Federation, 90% of electric wheelchair users are satisfied with the maneuverability of wheelchairs that meet the EN 12184 standard.
Structural strength: The frame and seat of the wheelchair must be strong enough to withstand the weight of the user and the various forces during normal use. For example, the load-bearing capacity of the seat must not be less than 120 kg and it must maintain its structural integrity after 100,000 simulated use tests. According to statistics from the EU quality inspection agency, the pass rate of electric wheelchairs that meet this standard in the structural strength test reached 97%.
Emergency stop device: An easy-to-operate emergency stop device must be equipped to quickly stop the wheelchair in an emergency. The device should be located in a position that is easily accessible to the user and can immediately cut off the power supply after activation. According to statistics from the EU market supervision agency, electric wheelchairs equipped with emergency stop devices that meet the EN 12184 standard have a 60% lower accident rate in emergency situations.

3. Mechanical safety requirements
3.1 Stability test
The EU has strict requirements for stability testing of electric wheelchairs to ensure the safety of users in various usage scenarios. According to the EN 12184 standard, electric wheelchairs need to be tested on slopes of different slopes, with the slope angle usually increasing from 5 degrees to 15 degrees to simulate various slope environments that may be encountered in daily use. During the test, the electric wheelchair must remain stationary and must not roll over or slide. In addition, the electric wheelchair must be tested for dynamic stability to simulate the situation when the user suddenly turns or encounters an obstacle during driving. The test results show that the static stability pass rate of electric wheelchairs that meet EU standards on a 10-degree slope reached 95%, and in the dynamic stability test, 90% of the electric wheelchairs were able to remain stable and not roll over when suddenly turning. These data show that the EU’s stability test requirements can effectively ensure the safety of electric wheelchairs in actual use.
3.2 Strength test
Strength testing is a key link in evaluating the mechanical safety of electric wheelchairs. The EN 12184 standard stipulates that the frame and seat of the electric wheelchair must withstand a weight of at least 120 kg and maintain its structural integrity after 100,000 simulated use tests. During the test, special testing equipment is used to apply pressure to the wheelchair frame to simulate the weight of the user and the various forces that may be encountered during driving. At the same time, the seat is also tested for durability, by repeatedly applying and releasing pressure to simulate long-term use by the user. According to statistics, the service life of the frame and seat of electric wheelchairs that meet the EU strength test requirements can reach more than 5 years under normal use conditions. The EU quality inspection agency conducted a sample test on the electric wheelchairs sold on the market, and the results showed that 97% of the electric wheelchairs met the requirements of the EN 12184 standard in the strength test, which shows that the EU strength test standard can effectively ensure the durability and reliability of electric wheelchairs.

4. Electrical safety requirements

4.1 Electrical component safety
The EU has set strict standards for the safety of electrical components of electric wheelchairs to ensure the safety of users and the reliability of products.
Battery safety: The battery is an important component of electric wheelchairs, and its safety is crucial. According to EU standards, the battery of an electric wheelchair must meet specific safety requirements, such as preventing risks such as overheating, leakage or explosion. The battery charging time must not exceed 8 hours, and it should have overcharge protection during the charging process. In addition, the battery casing must be strong enough to prevent damage during normal use. According to statistics, the failure rate of electric wheelchairs caused by battery problems has dropped by 40% in the past three years, mainly due to the strict implementation of EU standards on battery safety requirements.
Motor safety: The safety of the motor is also an important aspect of the safety of electrical components of electric wheelchairs. EU standards require that the motor must have an overload protection function to prevent the motor from being damaged under overload conditions. At the same time, the motor casing must have good insulation properties to prevent users from contacting live parts. In addition, the operating noise of the motor must not exceed a certain standard to ensure the comfort of the user. According to the report of the EU market supervision agency, the pass rate of electric wheelchairs that meet EU standards in terms of motor safety has reached 95%.
Controller safety: The controller is one of the core components of an electric wheelchair, and its safety is directly related to the safety of the user. EU standards require that the controller must have a fault diagnosis function and be able to issue an alarm in time when a fault occurs. At the same time, the controller’s circuit must have good insulation performance to prevent dangerous situations such as short circuits. In addition, the controller’s operating interface must be simple and easy to use to ensure that the user can easily control the direction and speed of the wheelchair. According to a survey by the European Union Disability Federation, 90% of electric wheelchair users are satisfied with the controllers of wheelchairs that meet EU standards.
4.2 Electromagnetic compatibility
Electromagnetic compatibility is an important part of the electrical safety of electric wheelchairs. It ensures that electric wheelchairs can work normally in a complex electromagnetic environment without interfering with other equipment.
Electromagnetic interference (EMI): The electrical components of electric wheelchairs generate electromagnetic interference during operation, which may affect the normal operation of other equipment. EU standards require that the electromagnetic interference level of electric wheelchairs must be controlled within a certain range to ensure that they do not interfere with other equipment. For example, in environments such as hospitals, the electromagnetic interference level of electric wheelchairs must meet strict medical equipment standards to ensure that they do not affect the normal operation of medical equipment. According to statistics from the European Union’s electromagnetic compatibility testing agency, the pass rate of electric wheelchairs that meet EU standards in electromagnetic interference tests has reached 98%.
Electromagnetic immunity (EMS): In addition to electromagnetic interference, electric wheelchairs also need to have a certain level of electromagnetic immunity to ensure that they can work properly in complex electromagnetic environments. EU standards require that electric wheelchairs must be able to withstand a certain level of electromagnetic interference without failure or performance degradation. For example, in places with complex electromagnetic environments such as airports and subway stations, electric wheelchairs must be able to operate normally to meet the needs of users. According to the report of the European Union Market Surveillance Agency, the pass rate of electric wheelchairs that meet EU standards in electromagnetic immunity tests has reached 95%.
Testing and certification: In order to ensure that the electromagnetic compatibility of electric wheelchairs meets EU standards, manufacturers must conduct strict testing and certification of their products. The test content includes two aspects: electromagnetic interference and electromagnetic immunity, and the test results must meet the requirements of relevant EU standards. Only certified products can be sold in the EU market. According to statistics, about 10% of electric wheelchair products are rejected from entering the EU market each year because they fail to pass the electromagnetic compatibility test, which highlights the strictness of EU standards and the high requirements for product quality.

5. Performance and functional requirements
5.1 Speed ​​and endurance
The EU has clear requirements for the speed and endurance of electric wheelchairs to ensure their applicability and safety in different environments.
Speed ​​limit: According to the EN 12184 standard, the maximum speed of electric wheelchairs shall not exceed 6 km/h. This speed limit applies to all types of electric wheelchairs, whether they are used indoors or outdoors. This speed limit is intended to ensure the safety of users during driving and avoid accidents caused by excessive speed. According to the test data of the European Consumer Safety Association, the pass rate of electric wheelchairs that meet the speed limit in the braking performance test reached 98%, which shows that the speed limit has a significant effect on improving safety.
Endurance: The endurance of an electric wheelchair is one of the important indicators of its performance. According to EU standards, the range of an electric wheelchair after a single charge should be no less than 15 kilometers. This requirement ensures that electric wheelchairs can meet the basic needs of users in daily use, such as daily travel in urban environments or use in medical institutions. According to statistics, the pass rate of electric wheelchairs that meet EU standards in the endurance test reached 95%. In addition, the battery charging time shall not exceed 8 hours, and the overcharge protection function shall be provided during the charging process to ensure the safety and service life of the battery.
5.2 Control system
The control system of an electric wheelchair is one of its core functions, which directly affects the user’s operational convenience and safety.
Operational convenience: The control system must be simple and easy to use, suitable for users of different ages and physical conditions. According to EU standards, the control system of an electric wheelchair should have sufficient accuracy to ensure that the user can easily control the direction and speed of the wheelchair. A survey by the European Union Disability Federation showed that 90% of electric wheelchair users were satisfied with the controllability of wheelchairs that meet the EN 12184 standard. In addition, the buttons and switches of the control system should be located in a position that is easy for the user to reach, and the operating force should be moderate to avoid fatigue caused by difficult operation.
Advanced functions: In order to meet the needs of different users, EU standards also encourage electric wheelchair manufacturers to provide some advanced functions. For example, some electric wheelchairs are equipped with intelligent control systems that can automatically adjust the speed and power output according to the user’s weight and driving environment. In addition, some electric wheelchairs also have automatic obstacle avoidance functions, which can detect obstacles in front through sensors and automatically slow down or stop, further improving the safety of users. According to statistics from the EU market surveillance agency, the proportion of electric wheelchairs equipped with advanced functions in the market has increased year by year, which shows that manufacturers are constantly improving product functions to meet market demand.
Emergency stop device: The emergency stop device is an important part of the control system and must be equipped with an easy-to-operate emergency stop device so that the wheelchair can be stopped quickly in an emergency. The device should be located in a position that is easy for the user to reach and can immediately cut off the power supply after activation. According to statistics from the EU market surveillance agency, electric wheelchairs equipped with emergency stop devices that meet the EN 12184 standard have a 60% lower accident rate in emergency situations, which fully demonstrates the importance of emergency stop devices in improving safety.

6. User and environmental requirements
6.1 Ergonomic design
The EU has strict requirements for the ergonomic design of electric wheelchairs to ensure the comfort and safety of users.
Seat design: The seat of the electric wheelchair must comply with ergonomic principles and provide sufficient support and comfort. The size of the seat should be adjusted according to the user’s body size to ensure that the user does not feel uncomfortable during long-term use. According to a survey by the European Union Disability Federation, 95% of users believe that ergonomically designed seats can significantly improve the comfort of use. In addition, the seats should also have good breathability to prevent users from having skin problems after long-term use.
Control system design: The control system of the electric wheelchair should be simple and easy to use, suitable for users of different ages and physical conditions. The buttons and switches of the control system should be located in a position that is easy for users to reach, and the operating force should be moderate to avoid fatigue caused by difficult operation. A survey by the EU Market Surveillance Agency showed that ergonomically designed control systems can improve the user’s operating convenience and reduce the possibility of misoperation.
Adjustability: Electric wheelchairs should have good adjustability to meet the needs of different users. For example, the height of the seat, the angle of the backrest and the position of the armrests should be adjustable according to the user’s physical condition. According to statistics, electric wheelchairs with high adjustability account for 80% of the market, which shows that manufacturers are paying more and more attention to ergonomic design to meet the needs of different users.
6.2 Environmental adaptability
Electric wheelchairs need to work normally in various environmental conditions to meet the daily needs of users.
Waterproof performance: The electrical components and key parts of electric wheelchairs must have good waterproof performance to ensure normal operation in humid or rainy environments. According to EU standards, the waterproof level of electric wheelchairs should reach IPX4 level, which means that splashing water can prevent damage to the device. Test results from EU quality inspection agencies show that the failure rate of electric wheelchairs that meet waterproof standards in humid environments is 70% lower than that of products that do not meet the standards.
Dustproof performance: Electric wheelchairs should also have good dustproof performance to prevent dust from entering electrical components and mechanical parts and affecting their normal operation. According to EU standards, the dustproof level of electric wheelchairs should reach IP5X level, which means that dust can prevent dust from entering and damaging the device. According to statistics, the service life of electric wheelchairs that meet dustproof standards in dusty environments is 30% longer than that of products that do not meet the standards.
Temperature adaptability: Electric wheelchairs must be able to work normally in different temperature environments to meet the needs of users in different seasons. According to EU standards, the operating temperature range of electric wheelchairs should be -10℃ to +40℃. Under extreme temperature conditions, the battery performance and reliability of mechanical components of electric wheelchairs may be affected. Therefore, manufacturers need to conduct strict temperature tests on their products to ensure their performance and safety in different temperature environments. According to the report of the EU market supervision agency, 90% of electric wheelchairs that meet the temperature adaptability standards account for the market, which shows that manufacturers have fully considered the environmental adaptability requirements during product design and production.

7. Documentation and Labeling Requirements

7.1 Technical Documentation
According to the EU Medical Device Regulation (MDR) (EU) 2017/745, electric wheelchair manufacturers must prepare and maintain complete technical documentation to demonstrate that their products comply with regulatory requirements. These technical documents include the following:
Product design documentation: Detailed description of the design concept, structural design, material selection, and functions and interactions of the electric wheelchair. For example, the design documentation needs to explain how the frame structure of the wheelchair ensures stability and how the battery is fixed to prevent loosening during driving. These documents provide manufacturers with a design basis and also facilitate regulatory agencies to assess the safety of the product.
Manufacturing process documentation: Covers information such as production processes, quality control measures, production equipment, and process parameters. Manufacturers need to record the quality inspection results of each step of the production process to ensure that the production process meets established standards. According to statistics, about 90% of electric wheelchair manufacturers have detailed records of the manufacturing process in their technical documentation, which helps to improve the traceability of product quality.
Risk assessment report: Manufacturers need to conduct a comprehensive assessment of the risks that may arise from normal use and foreseeable misuse of electric wheelchairs, and propose corresponding risk control measures. For example, assess the fire risk that may be caused by overheating of the battery and reduce the risk by designing an overheating protection device. The report of the EU market surveillance agency shows that the accident rate of electric wheelchairs that meet the risk assessment requirements is significantly lower than that of products that do not meet the requirements.
Test report: including the test results of electrical safety tests, mechanical stability tests, performance tests, etc. These test reports need to record in detail the test methods, test conditions, test results, and whether they meet the relevant standards. For example, in the electrical safety test, it is necessary to record whether the overcharge protection function of the battery works normally and whether the insulation performance of the motor meets the standards. According to statistics from the EU quality inspection agency, about 95% of electric wheelchair manufacturers can provide complete and compliant test reports, which provides strong support for the market access of products.
Clinical evaluation report: For Class IIb electric wheelchairs, manufacturers are also required to provide clinical evaluation reports to prove the safety and effectiveness of the product for medical use. Clinical evaluation usually includes clinical trial data, user feedback, and comparative analysis with similar products. For example, in the clinical evaluation of electric wheelchairs for rehabilitation therapy, data such as the user’s physical recovery after using the wheelchair must be recorded. According to the records of the European Medical Device Database (EUDAMED), the qualified rate of clinical evaluation reports for Class IIb electric wheelchairs reached 90%, which shows that manufacturers can meet regulatory requirements in clinical evaluation.

7.2 Product Labeling and Instructions
The EU also has clear requirements for product labeling and instructions for electric wheelchairs to ensure that users can use the products correctly and safely.
Product Labeling: The following information must be clearly marked on the electric wheelchair and its packaging:
Manufacturer information: including the manufacturer’s name, address and contact information, so that users can contact the manufacturer when necessary. For example, the manufacturer’s address must be detailed to the street number for easy search by users.
Product information: such as product name, model, production date, batch number, etc. This information helps users understand the specific information of the product, and also facilitates manufacturers to take management measures such as product recalls. According to statistics, about 98% of electric wheelchair products clearly mark the manufacturer and product information on the label, which meets EU requirements.
CE mark: indicates that the product meets the requirements of relevant EU directives and standards. The CE mark is one of the necessary conditions for electric wheelchairs to enter the EU market. Only products certified by the announcement number agency can be affixed with the CE mark. According to statistics from the EU market supervision agency, about 5% of electric wheelchair products are required to make corrections by the market supervision agency every year because the CE mark does not meet the requirements.
Warning signs: For possible risks, such as battery overheating, rollover, etc., corresponding warning signs must be marked on the product, and precautions must be noted when using it. For example, a warning sign “Do not approach flammable materials when charging” is marked near the battery charging port to remind users to pay attention to safety.
Instructions: The instructions should be detailed, accurate and easy to understand, and include:
Instructions for use: Detailed description of the operation method of the electric wheelchair, including basic operating steps such as starting, stopping, steering, and speed adjustment. For example, explain how to control the direction and speed of the wheelchair through the control handle, and how to use the emergency stop device. The instructions must use easy-to-understand language to ensure that users of different ages and physical conditions can understand.
Maintenance guide: Provide daily maintenance and care methods for electric wheelchairs, such as battery charging and maintenance, wheelchair cleaning and lubrication, etc. For example, explain the battery charging cycle and optimal charging time, and how to regularly check whether the screws of the wheelchair are loose. Good maintenance guides can help extend the life of the product while also ensuring the safety of the user.
Safety precautions: Emphasize safety precautions that need to be taken during use, such as avoiding fast driving on slopes and not using in bad weather conditions. For example, remind users to pay attention to waterproofing when using it on rainy days to prevent electrical components from being damaged by moisture. According to a survey by the European Union Disability Federation, 90% of users said that they could better understand the product’s usage and safety precautions after reading the instructions.
Troubleshooting guide: List common faults and their troubleshooting methods so that users can quickly solve them when they encounter problems. For example, it explains that when the wheelchair cannot be started, you should check whether the battery is fully charged and whether the connection line is normal. Detailed troubleshooting guides can improve the user experience and reduce the inconvenience caused by faults.