GB/T 41697-2022Assistive products for persons with disability - General requirements and test methods (English PDF)

1 Scope

This document specifies the general requirements, materials, sound and vibration, electromagnetic compatibility, electrical safety, liquid

Spills, sprays, leaks and ingress of bodies, surface temperature, sterility, safety of moving parts, protection against body entrapment, folding and adjustment devices, handles,

Support or suspension aids, portable and mobile rehabilitation aids, surfaces, edges, corners and protrusions, hand-held rehabilitation aids, small

Parts, stability, forces on human soft tissue, ergonomic principles, requirements for information provided by the manufacturer, packaging, and inspection reports.

This document is applicable to the products and tests of medical device rehabilitation aids, and other types of rehabilitation aids refer to this document.

Note. Some rehabilitation aids have corresponding product standards, such as prostheses, orthoses, wheelchairs, walkers, hearing aids, vision aids, etc., the products are given priority standard.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, all dated citations

For reference documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

used in this document.

GB/T 3767 Acoustic sound pressure method - Engineering method for determining sound power level of noise source and sound energy level of approximate free field above reflecting surface

GB/T 3768 Acoustic sound pressure method to determine the sound power level and sound energy level of noise sources easy law

GB/T 4208 enclosure protection class (IP code)

GB 4706.1 Safety of Household and Similar Electrical Appliances Part 1.General Requirements

GB 4706.2 Safety of Household and Similar Electrical Appliances Part 2.Particular Requirements for Electric Irons

GB 4943.1 Information Technology Equipment Safety Part 1.General Requirements

GB 8898 Audio, Video and Similar Electronic Equipment Safety Requirements

GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance

GB 9706.225 Medical Electrical Equipment Part 2-25.Special Requirements for Basic Safety and Basic Performance of Electrocardiographs

GB/T 16432 Classification and Terminology of Rehabilitation Assistive Devices

GB/T 16754 Design principles of mechanical safety emergency stop function

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process

GB 17625.1 Electromagnetic Compatibility Limits Harmonic Current Emission Limits (Each Phase Input Current of Equipment<=16A)

GB 17625.2 Electromagnetic compatibility limit for each phase rated current <= 16A and unconditional access equipment in the public low-voltage power supply system

Limitation of voltage variations, voltage fluctuations and flicker generated in the system

GB/T 17626.3 Electromagnetic Compatibility Test and Measurement Technology Radio Frequency Electromagnetic Field Radiation Immunity Test

GB/T 17626.8 Electromagnetic Compatibility Test and Measurement Technology Power Frequency Magnetic Field Immunity Test

GB 17927.1 Evaluation of the ignition resistance of upholstered furniture, mattresses and sofas - Part 1.Smoldering cigarettes

GB 17927.2 Evaluation of ignition resistance of upholstered furniture, mattresses and sofas - Part 2.Simulated match flame

GB 18279.1 Sterilization of Healthcare Products Ethylene Oxide Part 1.Development, Validation and Routine Control of Sterilization Processes for Medical Devices system requirements

GB 18280.1 Sterilization Radiation for Healthcare Products Part 1.Requirements for Development, Validation and Routine Control of Sterilization Processes for Medical Devices […]