GB/T 44423-2024 Active National standards

GB/T 44423-2024 General requirements for near-infrared brain function rehabilitation assessment equipment

GB/T 44423-2024 General requirements for near-infrared brain function rehabilitation assessment equipment

Publish Date: 2024-08-23 Implement Date: 2024-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 44423-2024
Standard Type: National standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: The comprehensive use of assistive devices by people with disabilities
Publish Date: 2024-08-23
Implement Date: 2024-12-01
Pages: 24 pages

Scope

This document specifies the classification, components, and requirements of near-infrared brain function rehabilitation assessment equipment (hereinafter referred to as "equipment"), describes the corresponding test methods, and stipulates the content of inspection rules, markings, user manuals, packaging, transportation, and storage.
This document applies to the design, production, inspection, and use of equipment used to evaluate the brain function status of people with brain function impairments, developmental disabilities, or motor, cognitive, or mental disorders caused by lesions during the rehabilitation process, using near-infrared spectroscopy technology.

Development Information

Word Count: 36 Thousand words Pages: 24 pages

Referenced Standards

GB 9706.271-2022 Medical electrical equipment—Part 2-71:Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy(NIRS) equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 25000.51-2016 Systems and software engineering—Systems and software Quality Requirements and Evaluation (SQuaRE)—Part 51:Requirements for quality of Ready to Use Software Product(RUSP) and instructions for testing GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4208-1993 Degrees of protection provided by enclosure (IP code) GB/T 4208-2008 Degrees of protection provided by enclosure(IP code) GB/T 4208-2017 Degrees of protection provided by enclosure(IP code) GB 7247.1-2001 Safety of laser products—Part 1:Equipment classification, requirements and user's guide GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance 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 9706.257-2021 Medical electrical equipment—Part 2-57:Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,diagnostic,monitoring and cosmetic/aesthetic use GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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