GB/T 41696-2022Classification and general technical requirements of lower limb rehabilitation training devices (English PDF)
下肢康复训练设备的分类及通用技术条件
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
October 14, 2022
Implementation date
February 1, 2023
Scope
GB/T 41696-2022 is the English-translated version of 下肢康复训练设备的分类及通用技术条件.
GB/T 41696-2022 classifies lower limb rehabilitation training devices and sets the general technical requirements they have to meet. It covers the classification, by user, by training posture, by training method and by main training function, together with general rules, requirements, test methods, marking and instructions for use.
It applies to equipment used by people with lower limb dysfunction, and excludes combined or alternating upper and lower limb trainers, balance trainers, and walking or standing aids such as walkers, wearable lower limb exoskeleton robots, crutches, walking sticks, standing frames and standing beds.
The requirements cover structure, operating parameters, muscle stimulators, safety protection, stability, mechanical strength and operating noise, with a test for each of them. Issued on 14 October 2022, it has applied since 1 February 2023.
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Document preview — GB/T 41696-2022
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 30
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Category
- 4.1 Classification by use object
- 4.2 Classification by training pose
- 4.3 Classification by training method
- 4.4 Classification by Main Training Function
- 5 General
- 6 Requirements
- 6.1 Structural Requirements
- 6.2 Operating parameters
- 6.3 Muscle stimulators
- 6.4 Safety protection function
- 6.5 Stability
- 6.6 Mechanical strength
- 6.7 Operating noise
- 6.8 Other general safety requirements
- 7 Test method
- 7.1 Test Environment
- 7.2 Structural Requirements Test
- 7.3 Running parameter test
- 7.4 Muscle Stimulator Test
- 7.5 Safety protection function test
- 7.6 Stability test
- 7.7 Mechanical strength test
- 7.8 Working noise test
- 7.9 Other general safety requirements test
- 8 Signs and Instructions for Use
- 8.1 Signs
- 8.2 Instructions for use
- Reference
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.
1 Scope
This document specifies the classification, general rules, requirements, test methods, signs and instructions for use of lower extremity rehabilitation training equipment.
This document applies to the lower extremity rehabilitation training equipment (hereinafter referred to as the equipment) used by persons with lower extremity dysfunction and its classification. This document does not apply to the following devices.
--- Upper/lower extremity combined training equipment, upper/lower extremity exchange training equipment;
--- Balance training equipment;
--- Assisted walking and standing equipment, such as walkers, wearable lower limb exoskeleton robots, crutches, walking sticks, standing frames, standing beds, etc.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 230.1 Rockwell hardness test of metallic materials - Part 1: Test method
GB 9706.1-2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance
GB/T 14775-1993 General ergonomic requirements for manipulators
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process
GB/T 19678.1 Compilation, Content and Presentation Method of Instructions for Use Part 1: General Rules and Detailed Requirements
GB 24436-2009 General requirements for the safety of rehabilitation training equipment
YY9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Collateral Standard. Electromagnetic and Capacitive requirements and tests
YY9706.210 Medical electrical equipment Part 2-10.Particular requirements for basic safety and basic performance of nerve and muscle stimulators
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Lower limb rehabilitation training device
Equipment for rehabilitation training for people with lower extremity dysfunction.
3.2 Safe distance
In order to avoid mechanical hazards (such as shearing, pinching, crushing, friction, etc.) in the area accessible to the human body, the moving parts of the equipment are connected to adjacent moving parts.
The gap that should be satisfied between moving parts, or between moving parts and fixed rigid parts.
3.3 Power drive
A power source provided by an external source (such as an electric motor, etc.) during training.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 230.1Metallic materials - Rockwell hardness test - Part 1: Test method
- GB 9706.1-2020Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14775-1993General ergonomics requirements for controller
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 19678.1Preparation of instructions for use -- Structuring, content and presentation -- Part 1: General principles and detailed requirements
- GB 24436-2009Rehabilitation training instrument - General safety requirements
YY9706.102 · YY9706.210
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Related Standards
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 requirements for controller
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