摘要
医疗器械风险是指医疗器械损害的发生概率与医疗器械损害严重程度的结合。医疗器械的风险将可能引发对人体的伤害甚至死亡的损害,或对社会财产和环境造成损坏。因此必须对医疗器械实施风险管理,将医疗器械风险控制在可接受水平,以确保医疗器械安全有效。
Medical device risk is defined as injury caused by the device and severity of device destruction. The medical deviced risk might cause injury even death in patients or damage of properties and environment. Therefore, the risks should be carfully managed to ensure the safe application of medical devices.
出处
《中国医学装备》
2009年第6期15-20,共6页
China Medical Equipment
关键词
医疗器械
风险
管理标准
Medical device
Risk
Management standard
