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 (English Version)
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest
GB 9706.271-2022
Scope
Replacement: This document applies to the basic safety and essential performance of functional near-infrared spectroscopy equipment (hereinafter referred to as ME equipment) for the intended purpose of assisting diagnosis by itself or as part of an ME system. The scope of this document does not include: a) as part of ME EQUIPMENT intended to measure hemoglobin oxygen saturation in microvessels (capillaries, arterioles and venules); b) not intended to be used to obtain the output of functional NIR spectroscopy equipment Near-infrared spectroscopy (NIRS) tissue oximeters; c) pulse oximeters not intended to be used to obtain the output of functional near-infrared spectroscopy equipment, see YY0784 for requirements; d) frequency domain and time domain for functional near-infrared spectroscopy As far as equipment is concerned, inspection procedures other than those specified in this document may be used; e) functional near-infrared spectroscopy equipment used to measure changes in the concentration of chromophores other than oxygenated and deoxygenated hemoglobin may use inspection procedures different from those specified in this document. program. 201.
GB 9706.271-2022 Referenced Document
GB 7247.1-2012 Safety of laser products.Part 1:Equipment classification and requirements
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
YY 0784 Medical electrical equipment.Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use
YY 9706.257-2021 Medical electrical equipment Part 2-57: Specific requirements for basic safety and basic performance of non-laser light source equipment used for treatment, diagnosis, monitoring and plastic surgery/medical aesthetics
YY/T 9706.106 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standards: Availability
GB 9706.271-2022 history
2022GB 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