医疗设备是指直接或间接的主体设备,设备、器械、体外诊断试剂、校准器,材料和其他类似或相关的项目,包括对计算机软件的需求。
获得的效用主要是通过物理方式,不是由药理学、免疫学或代谢方式,或虽然有途径参与但只有发挥辅助作用。
疾病诊断的目的,预防、监测、治疗或减轻的诊断、监测、治疗;损害赔偿,救援或函数;生理结构或生理过程检查、更换,调整或支持;生命支持或维护怀孕;控制;通过检验样本的人体,为健康提供信息或诊断的目的
The purpose of a disease diagnosis, prevention, monitoring, treatment or alleviation of diagnosis, monitoring, treatment; damage compensation, relief or function; physiological structure or physiological process inspection, replacement, adjustment or support; life support or maintenance of pregnancy; control; through inspection of the sample from the human body, to provide information for health or diagnostic purposes