มอก. 3075 เล่ม 12-2564

Scope (English)

This standard outlines the basic safety and essential efficacy of the therapy apparatus. high flow rate respiratory system Contains introduction, scope, relevant purposes and standards, reference documents, definitions, general requirements, general test requirements, medical appliances, types of medical appliances and systems. Electrical Appliances, Identification of Marks and Documentation of Medical Electrical Appliances, Prevention of Electrical Hazards from Medical Appliances, Prevention of Mechanical Hazards of Medical Appliances and Electrical Appliance Systems, Protection of Electrical Appliances. Unwanted or excessive radiation, protection against overheating and other hazards, precision of control and procedures for use and protection, hazardous and unfavorable conditions of electrical appliances. Medical electrical programmable, medical electrical appliance structure, medical electrical appliance, electromagnetic compatibility of medical electrical appliance and electrical appliance system, coupling for gas conveyors used for inhalation, additional requirements for breathing gases and accessories, indication of operating time, function connection n, electrical wiring, safety of high flow respiratory therapy devices, electromagnetic interference - requirements and tests, applicability, general requirements, tests and Recommendations for Alarm Systems in Medical Appliances and Electrical Systems, Requirements for Electrical Appliances and Electrical Systems for Home Care