GB/T 41696-2022 Active National standards

GB/T 41696-2022 Classification and general technical requirements of lower limb rehabilitation training devices

GB/T 41696-2022 Classification and general technical requirements of lower limb rehabilitation training devices

Publish Date: 2022-10-12 Implement Date: 2023-02-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 41696-2022

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Other medical equipment

Publish Date: 2022-10-12

Implement Date: 2023-02-01

Pages: 14 pages

Scope

This document specifies the classification, general principles, requirements, test methods, marking, and user instructions for lower limb rehabilitation training equipment.
This document is applicable to lower limb rehabilitation training equipment (hereinafter referred to as equipment) used by individuals with lower limb dysfunction and its classification.
This document is not applicable to the following equipment:
——Combined upper/lower limb training equipment and upper/lower limb interchangeable training equipment;
——Balance training equipment;
——Assisted walking and standing equipment, such as walkers, wearable lower limb exoskeleton robots, crutches, canes, standing frames, standing beds, etc.

Development Information

Word Count: 30 Thousand words Pages: 14 pages

Referenced Standards

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 24436-2009 Rehabilitation training instrument—General safety requirements GB/T 230.1-2004 Metallic Rockwell hardness test—Part1:Test method(scales A、B、C、D、E、F、G、H、K、N、T) GB/T 230.1-2009 Metallic materials—Rockwell hardness test—Part 1:Test method(scales A、B、C、D、E、F、G、H、K、N、T) GB/T 230.1-2018 Metallic materials—Rockwell hardness test—Part 1:Test method GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 19678.1-2018 Preparation of instructions for use—Structuring，content and presentation—Part 1:General principles and detailed requirements YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Related Standards

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GB/T 17995-1999 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment

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GB/T 18990.1-2003 Luteinizing hormone(LH)test strip—Part 1:Ovulation test strip

Publish Date: 2003-03-05

GB/T 18990.2-2003 Replaced

GB/T 18990.2-2003 Luteinizing hormone(LH) test strip—Part 2:Sterility test strip

Publish Date: 2003-03-05

GB/T 18990.3-2003 Replaced

GB/T 18990.3-2003 Luteinizing hormone(LH) test strip Part 3:Contraceptive test strip

Publish Date: 2003-03-05

YY 0476-2004 Abolished

YY 0476-2004 Irrigating solutions for ophthalmic surgery

Publish Date: 2004-03-23

YY 0477-2004 Replaced

YY 0477-2004 Rigid gas permeable contact lenses for orthokeratology

Publish Date: 2004-03-23