经颅直流电刺激仪质量控制技术规范OA

Transcranial direct current stimulation(tDCS)devices are medical instruments that deliver low-intensity direct cur‐rent(1-2 mA)to specific cortical regions via electrodes for therapeutic or adjunctive purposes.To standardize the design,develop‐ment,manufacturing,inspection,quality control,and preclinical evaluation of such devices,this technical specification clarifies the terminology and definitions,classification and composition,performance and functional requirements,test methods,inspection rules,marking and labeling,instruction manuals,packaging,and storage,based on relevant requirements for basic safety,environmental testing,biological evaluation,usability engineering,electrodes for nerve and muscle stimulators,electromagnetic compatibility,and software life cycle.This specification places particular emphasis on output current error,output voltage,output current,impedance measurement error,electrode and electric field design,electrode pad impedance,biocompatibility,electrical safety,electromagnetic compatibility,environmental adaptability,software data logging,user interface,and alarm prompts,and specifies the corresponding test methods for appearance,performance,function,safety,and environmental adaptability.This specification is applicable to the technical evaluation,registration testing,factory inspection,and pre-use quality control of tDCS devices,and may serve as a refer‐ence for relevant organizations in product design,manufacturing,and testing.