Certification and Registration
Testing Standards for Rehabilitation Medical Devices
Category:
Rehabilitation Equipment
GB/Z 13800-2021 Manual wheelchairs
GB/Z 13800 specifies the model designation, requirements, test dummies, test methods, documentation, marking and packaging, test reports, and inspection rules for manual wheelchairs.
GB/Z 13800 applies to manually operated wheelchairs for a single occupant only, with a user mass not exceeding 100 kg. According to the classification in GB/T 16432, applicable wheelchair types include manual wheelchairs, two-hand drive wheelchairs, lever-drive wheelchairs, single-hand drive wheelchairs, foot-propelled wheelchairs, and manually operated wheelchairs controlled by caregivers.
GB/Z 13800 does not apply to competitive wheelchairs or dance wheelchairs used by persons with disabilities.
GB/T 12996-2012 Electrically powered wheelchair
GB/T 12996 specifies terminology and model designation principles for electrically powered wheelchairs, as well as requirements for surface finish, assembly, external dimensions, performance, structural strength, flame resistance, environmental conditions, and power and control systems.
It also specifies corresponding test methods, inspection rules, documentation requirements, information disclosure, marking, and packaging requirements.
GB/T 12996 applies to electrically powered wheelchairs intended for a single occupant, where the combined mass of the user and operator does not exceed 100 kg. These wheelchairs are powered by electricity and intended for use by persons with disabilities or elderly users, including electric mobility scooters.
According to GB/T 16432, applicable categories include manually steered electric wheelchairs (such as electric scooters) and power-steered electric wheelchairs.
This standard does not apply to manually operated wheelchairs equipped with electric assist systems.
GB/T 18029.1-2008 Wheelchairs - Part 1: Determination of static stability
GB/T 18029.1 specifies the test method for determining the static tipping stability of wheelchairs, including electric scooters.
GB/T 18029.1 applies to wheelchairs and mobility aids classified under GB/T 16432 category 12 21 for indoor and outdoor use. The user mass shall not exceed the maximum mass of the test dummy specified in GB/T 18029.11.
GB/T 18028.2-2009 Safety of machinery — Relationship of GB/T 16855.1 to GB/T 15706
GB/T 18028.2 explains the relationship between GB/T 15706 and GB/T 16855.1 for reducing injury risks.
It focuses particularly on the relationship between the application of safety-related components in control systems and the processes of risk assessment and risk reduction.
GB/T 18028.2 also applies to the relationship between GB/T 16855.1 and GB/T 15706, as well as the relationship between GB 28526 and GB/T 15706.
GB/Z 18029.3-2021 Wheelchairs — Part 3: Determination of effectiveness of brakes
GB/Z 18029.3 specifies test methods for evaluating the braking performance of manually operated wheelchairs and single-user electric wheelchairs, including electric scooters, with a maximum speed not exceeding 15 km/h.
GB/Z 18029.3 also specifies requirements for manufacturer information disclosure.
GB/Z 18029.4-2021 Wheelchairs — Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
GB/Z 18029.4 specifies a method for determining the theoretical driving range of electric wheelchairs, including electric scooters, by measuring energy consumption during operation and the rated capacity of the wheelchair battery.
GB/Z 18029.5-2021 Wheelchairs — Part 5: Determination of dimensions, mass and maneuvering space
GB/Z 18029.5 specifies test methods for determining wheelchair dimensions and mass.
GB/Z 18029.5 includes methods for determining external dimensions and the maneuvering space required during common daily wheelchair operations when occupied by a wheelchair user.
GB/Z 18029.5 specifies requirements for dimensions and mass and includes five informative annexes.
GB/Z 18029.5 applies to manual wheelchairs and electrically powered wheelchairs, including electric scooters.
GB/T 18029.6-2009 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
GB/T 18029.6 specifies test methods for determining the maximum speed, acceleration, and deceleration of electric wheelchairs, including electric scooters, designed for a single occupant with a maximum speed not exceeding 15 km/h.
GB/T 18029.7-2009 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
GB/T 18029.7 specifies methods for measuring wheelchair seat and wheel dimensions.
GB/T 18029.7 applies to wheelchairs and mobility vehicles for persons with disabilities with a user mass not exceeding 120 kg, intended for indoor and outdoor mobility at speeds not exceeding 15 km/h.
It applies to wheelchair categories classified according to GB/T 16432, including manually steered electric wheelchairs, power-steered electric wheelchairs, caregiver-controlled power wheelchairs, caregiver-controlled manual wheelchairs, dual rear-wheel-drive wheelchairs, dual front-wheel-drive wheelchairs, dual lever-drive wheelchairs, single-side-drive non-powered wheelchairs (propelled by one hand or one leg), and foot-propelled wheelchairs.
GB/T 18029.7 does not apply to wheelchairs with seat widths less than 212 mm.
GB/T 18029.7 does not specify nominal dimensions for wheelchair seats or wheels.
GB/T 18029.8-2008 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
GB/T 18029.8 specifies the requirements for static strength, impact strength, and fatigue strength of wheelchairs, including electric scooters, with a user mass not exceeding 100 kg, as well as the corresponding test methods and requirements for reporting test results.
GB/T 18029.8 test methods may also be used to verify manufacturer-specified limits exceeding those specified in this standard.
GB/T 18029.8 applies to manual wheelchairs operated by users or caregivers, as well as electrically powered wheelchairs for indoor and outdoor use. Electric wheelchairs covered by this standard have three or more wheels mounted on two parallel axles, with no more than two driven wheels, and a maximum speed not exceeding 15 km/h.
GB/Z 18029.9-2021 Wheelchairs — Part 9: Climatic tests for electric wheelchairs
GB/Z 18029.9 specifies requirements and test methods for determining the effects of water exposure, condensation, and temperature variations on the essential functions of electric wheelchairs, including electric scooters, designed for a single occupant with a maximum speed not exceeding 15 km/h.
GB/Z 18029.9 does not include requirements for corrosion resistance.
GB/Z 18029.10-2021 Wheelchairs — Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
GB/Z 18029.10 specifies the test method for determining the obstacle-climbing ability of electrically powered wheelchairs.
GB/T 18029.13-2008 Wheelchair - Part 13: Determination of friction of test surface
GB/T 18029.13 specifies a method for determining the coefficient of friction of a rough test surface, such as an unpolished concrete surface.If the method specified in this part is used to test smooth or polished surfaces, the measured coefficient of friction shall be uniform across the entire test surface.
GB/T 18029.14-2012 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooter - Requirements and test methods
GB/T 18029.14 specifies requirements and test methods for the power and control systems of electrically powered wheelchairs and electric mobility scooters.
GB/T 18029.14 specifies safety and performance requirements applicable under normal use conditions, as well as foreseeable misuse and fault conditions.
GB/T 18029.14 also specifies methods for measuring the forces required to operate controllers and establishes permissible force limits for certain operations.
GB/T 18029.14 applies to electrically powered wheelchairs and electric mobility scooters with a maximum speed not exceeding 15 km/h, intended for indoor, outdoor, and road use, and designed for single users with disabilities within the user mass range specified in GB/T 18029.11.
GB/T 18029.15-2008 Wheelchairs - Part 15: Requirement for information disclosure, documentation and labelling
GB/T 18029.15 specifies the information, documentation, labeling, and manufacturer’s pre-sale specification documents required to be provided with wheelchairs.
GB/T 18029.21-2012 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
GB/T 18029.21 specifies requirements and test methods for electromagnetic emissions and electromagnetic immunity of electrically powered wheelchairs and electric mobility scooters with a maximum speed not exceeding 15 km/h, intended for indoor and/or outdoor use by persons with disabilities.
GB/T 18029.21 also applies to manual wheelchairs equipped with external electric assist kits, but does not apply to vehicles designed to transport more than one person.
GB/T 18029.21 also specifies electromagnetic compatibility requirements and test methods for battery chargers used with electric wheelchairs and electric mobility scooters.
GB/T 18029.22-2009 Wheelchairs - Part 22: Set-up procedure s
GB/T 18029.22 specifies the adjustment procedures to be performed before testing adjustable wheelchairs according to the requirements of the GB/T 18029 series.
This part also specifies adjustment methods to be used when the manufacturer has not provided specific wheelchair adjustment instructions.
GB/T 18029.22 applies to manual and electrically powered wheelchairs, including electric scooters, intended for indoor or outdoor use.
SATISFY provides one-stop rehabilitation-related medical device testing services, including preliminary assessment, preparation and submission of technical documentation, complete test monitoring, report interpretation, data analysis, and corrective action recommendations.
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