Market Trends and Applicable Standards for Wheelchairs and Other Assistive Medical Devices

Aging Population and Market Expansion

According to data from the United Nations Department of Economic and Social Affairs (UN DESA), the global population aged 80 and above is expected to reach approximately 140 million by 2024, accounting for about 2% of the world's total population. With the accelerating aging of the global population, this number is projected to rise to approximately 250 million by 2040, making up about 3% of the global population. This demographic shift is profoundly altering the healthcare landscape worldwide. The expansion of the elderly population means that more people will face issues related to mobility impairments and physical function decline. Consequently, there is a growing demand for assistive medical devices.

However, the expansion of the assistive medical device market is not solely driven by the need for quantity but also by higher standards for product quality, comfort, and safety. To ensure a positive user experience, manufacturers must comply with strict international standards when designing and producing assistive medical devices. These international standards provide clear guidelines on the design, functionality, and safety requirements for such products.

Wheelchair Safety and Compliance

Wheelchairs are among the most representative assistive medical devices. The leading Total Quality Assurance provider to industries worldwide, Intertek is equipped with the capabilities to conduct comprehensive and in-depth testing of wheelchairs and related products. It provides manufacturers with certification testing according to multiple international standards.

1. Testing Capabilities in Accordance with International Standards

Different types of wheelchairs must meet varying standards depending on the region to which they are distributed. ITS Laboratory is fully equipped with testing facilities and experienced professionals, enabling them to conduct testing in compliance with the following standards:

• EN 12183: is applicable to manual wheelchairs with a maximum load of 250 kg.
• EN 12184: applies to electrically powered wheelchairs with a maximum speed of 15 km/h and a maximum load of 300 kg, as well as electric scooters with three or more wheels.
• ISO 7176 Series: cover various aspects of wheelchair performance, including strength tests, comfort assessments, and durability testing.
• GB/Z 13800 Manual Wheelchair.
• AS NZS 3695.1: specifies the design, manufacturing, and testing requirements for manual wheelchairs to ensure their safety, durability, and functionality. 

2. Comprehensive Functional Testing

• Comfort Evaluation: This involves assessing the design of the seat and backrest to ensure that users remain comfortable during extended use.
• Stability, Strength, and Durability Testing.
• Smart Feature Testing: to test electric drive systems, intelligent control systems, and other high-tech features, ensuring their safety, efficiency, and functionality.

Other Assistive Medical Devices

For walking aids such as canes and other assistive medical devices, Intertek has developed comprehensive testing capabilities, covering standards including:

1. Walkers:

• EN 11199-1: Standard for walking frames (walker frames).
• EN 11199-2: Standard for rolling walkers (rollators).
• EN 11199-3: Standard for walking aids with three or more wheels.

2. Crutches:

• ISO 11334-1: Standard for elbow crutches.
• ISO 11334-4: Standard for tripod or quadripod walking sticks.
• BS 4997: Standard for wooden axillary crutches.
• BS 5205: Standard for adjustable metal crutches.
• BS 5181: Standard for wooden walking sticks.

3. Other Standards:

• ISO 24415-1: Testing the friction of walking aid tips on dry and flat surfaces.
• ISO 24415-2: Testing the durability of crutch tips.

Consulting 
For more information about medical devices’ services and solutions, please scan the QR code below to contact us：

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Susie.su@intertek.com