GB/T 41696-2022
Classification and general technical requirements of lower limb rehabilitation training devices (English Version)
- Standard No.
- GB/T 41696-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 41696-2022
- Scope
- This document specifies the classification, general principles, requirements, test methods, signs and instructions for use of lower limb rehabilitation training equipment. This document is applicable to lower limb rehabilitation training equipment (hereinafter referred to as equipment) and its classification for people with lower limb dysfunction. This document does not apply to the following equipment: ——upper/lower limb combined training equipment, upper/lower limb interchangeable training equipment; ——balance training equipment; ——assistance walking and standing equipment, such as walkers, wearable lower limbs Skeletal robots, crutches, walking sticks, standing frames, standing beds, etc.
- Introduction
Interpretation of the classification system of lower limb rehabilitation equipment
Classification dimensions Core parameters Features of medical applications Training posture 5 posture modes Comparison with posture adaptation for hemiplegia caused by stroke and spinal cord injury Drive mode Active and passive hybrid control Covering training needs at different rehabilitation stages Function type Gait rehabilitation + muscle strength training Targeting postoperative recovery and neural remodeling
Analysis of key technical parameters
Training angle control: In passive mode, the set angle and the measured tolerance are ≤10% to ensure safe and gradual joint movement
Power drive speed: Maximum angular velocity 10°/s, slowest linear speed ≤0.5km/h to avoid startup risks
Detailed explanation of safety protection specifications
Ergonomic safety distance requirements:- Lower limb shear protection: main movement ≤30mm gap redundant design
- Foot escape channel: children's equipment ≥120mm emergency escape space
- Finger compression protection: recessed or <4mm closed structure
Medical equipment test specifications
Test items Instrument requirements Error threshold Angle calibration Digital angle meter DIN875 standard ±0.5° resolution Speed detection Laser speed meter ISO5725 standard ±0.1m/s accuracy Noise test Sound level meter ANSI standard ≤65dB(A) Standard evolution analysis: Corresponding to the upgrade requirements of the 2020 version of the Ministry of Health's "Outline of Quality Control of Rehabilitation Equipment", strengthening the subdivision verification items of children's equipment, and adding deep muscle stimulator EMC testing specifications
GB/T 41696-2022 Referenced Document
- GB 24436-2009 Rehabilitation training instrument.General safety requirements
- GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
- GB/T 14775-1993 General ergonomics reguirements for controller
- GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
- GB/T 19678.1 Prepara tion of instructions for use—Structuring，content and presentation—Part 1：General principles and detailed requirements
- GB/T 230.1 Metallic materials.Rockwell hardness test.Part 1:Test method
- YY 9706.102 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standards: Electromagnetic compatibility requirements and tests
- YY 9706.210 Medical electrical equipment Part 2-10: Specific requirements for basic safety and essential performance of nerve and muscle stimulators
GB/T 41696-2022 history
- 2022 GB/T 41696-2022 Classification and general technical requirements of lower limb rehabilitation training devices