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
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
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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