GB/T 41697-2022 Assistive products for persons with disability—General requirements and test methods
GB/T 41697-2022 Assistive products for persons with disability—General requirements and test methods
Basic Information
Scope
This document specifies the general requirements for medical device-type rehabilitation aids, including materials, sound and vibration, electromagnetic compatibility, electrical safety, liquid overflow, spraying, leakage, and ingress, surface temperature, sterility, safety of moving parts, prevention of body pinching, folding and adjustment devices, handles, supporting or suspending aids, portable and mobile rehabilitation aids, surfaces, edges, corners, and protruding parts, handheld rehabilitation aids, small parts, stability, forces on human soft tissues, ergonomic principles, requirements for information provided by manufacturers, packaging, and inspection reports.
This document applies to products and tests of medical device-type rehabilitation aids. Other types of rehabilitation aids should refer to this document.
Note: For some rehabilitation aids with corresponding product standards, such as prostheses, orthoses, wheelchairs, walkers, hearing aids, and vision aids, the product standards should be used preferentially.