The main content determined is the general technical requirements for the design and development of point-of-care test (hereinafter referred to as POCT) in vitro diagnostic medical devices, including design and development (general requirements, metrology traceability, ergonomics and human factors, electromagnetic compatibility, protection against electric shock, Protection against mechanical hazards, resistance to mechanical shock and impact, temperature limits of equipment, heat resistance, protection against liquid hazards, protection against released gases, explosions and implosion, components, lasers, heating devices, risk analysis, design changes) , markings and information provided by the manufacturer (markings and labels, instructions for use), analysis performance evaluation (general requirements, requirements for quantitative POCT products, requirements for qualitative POCT products), user verification (self-test point-of-care testing in vitro diagnostic medical equipment, non-self-testing point-of-care in vitro diagnostic medical devices), etc., to ensure the safety, reliability and intended use of point-of-care in vitro diagnostic medical devices (POCT) products.
T/ZMDS 40002-2021 history
2021T/ZMDS 40002-2021 Guidelines for design and development for in vitro diagnostic medical devices for point-of-care testing（POCT）