International standards and Hong Kong legal regulations for electric wheelchairs
Are there any international standards for electric wheelchairs?
There are international standards for electric wheelchairs, mainly formulated by the International Organization for Standardization (ISO). The ISO 7176 series of standards specifies test methods and evaluation criteria specifically for wheelchairs.
In these standards, requirements for multiple aspects of wheelchairs are specified to ensure that the quality and performance of wheelchairs meet international standards and provide manufacturers and users with a common benchmark for testing and evaluation.
ISO 7176 is an international standard specifically for electric wheelchairs and specifies the following requirements:
1. Size and weight restrictions: including load capacity, seat width, wheelchair length, height and width, etc.
2. Durability: A power wheelchair needs to still function properly after multiple tests.
3. Safety: including the wheelchair’s anti-skid properties, braking performance, seat belts and roll-over prevention devices, etc.
4. Performance: including the stability, controllability, turning radius, climbing ability, maximum speed and endurance of the wheelchair.
5. Electrical performance: including battery capacity, charging time, charger efficiency and battery life, etc.
In addition, ISO 7176 also specifies test methods for testing electric wheelchairs to ensure repeatability and comparability of test results.
These standards ensure the quality and performance of electric wheelchairs and can also be used in the development, testing and evaluation of wheelchair seats, and can help manufacturers produce products that better meet user needs. Enables electric wheelchair users to use their wheelchairs safely and comfortably.
Why can some electric wheelchairs be sold in the market even though they do not have ISO7176? or other standards?
ISO 7176 is an international standard. It is a non-mandatory standard and has no legal force. Manufacturers do not have to mark their products as complying with these standards. Therefore, even if some electric wheelchairs have not been tested and certified according to ISO 7176, they can still be sold on the market.
However, some countries or regions may have their own wheelchair-related standards or regulations, such as the European Union’s Medical Devices Directive , the British Medical Devices Regulation (MDR) , and the American ANSI/RESNA WC-1:2019 , Japan's JIS T 9203:2006 and the mainland's national standard GB/T 12996-2012 . These regulations place requirements on the safety and performance of wheelchairs. Manufacturers must ensure that their products comply with the requirements of these regulations or they may face liability and legal risks.
In addition, some manufacturers may voluntarily comply with the ISO 7176 standard to prove that their products meet international standards. Therefore, even if some electric wheelchairs are not certified to ISO 7176, these products can still be sold on the market if the manufacturer can prove that the product complies with other relevant standards and regulations, and consumers have confidence in the safety and performance of the product.
Are there any regulations for electric wheelchairs in Hong Kong?
The Hong Kong Special Administrative Region government's regulations on electric wheelchairs mainly involve two aspects, namely transportation and medical equipment .
In terms of transportation, Hong Kong's road traffic regulations do not provide specific regulations for electric wheelchairs, but the Hong Kong Transport Department recommends that users should pay attention to the traffic environment and pedestrian safety when using electric wheelchairs, and abide by traffic rules . In addition, the Hong Kong Transport Department also recommends that users should choose products that comply with international standards and relevant regulations.
In terms of medical devices, Hong Kong currently does not have specific legislation regulating electric wheelchairs. However, users can use electric wheelchairs only when their doctor certifies that they have mobility needs. However, electric wheelchairs are not covered by medical devices.
Some Hong Kong agents only list manufacturers with ISO 9001/ ISO 140001 management and environmental standards (some even do not), but the products do not have ISO7176 or equivalent certificates and cannot meet international safety standards; also be careful that some suppliers use other names instead or use Vague testimonial pictures for solicitation. So be careful when choosing.
Some large international brand models, such as Sunrise Quickie Q50R Carbon , Joy Rider , Zinger , Pride iGo Lite, even have multiple regional safety certificates, such as ISO-7176, MDR and ANSI.
Overall:
Hong Kong has partially regulated electric wheelchairs through different laws and regulations. It is recommended that Hong Kong still needs to formulate appropriate regulatory systems and standards to regulate the supply and use of wheelchairs and electric wheelchairs or walking aids in Hong Kong.
Edited by Hoho Medical Limited in 2023
