哪些产品属于高风险有源医疗器械,法规与标准中没有一个明确的定义。TüV南德意志集团(以下简称TüV SüD)专家指出:判断的关键在于产品功能或电器安全失效时对病人的风险。若医疗器械失效或异常可导致患者的死亡、严重伤害或其他不可接受的风险,那么该器械可以定义为高风险医疗器械。根据产品的预期用途,以下产品 Which products are high-risk active medical devices, laws and standards are not a clear definition. Experts at TÜV SÜD (TüV SüD) point out that the key to judgment lies in the patient’s risk to the functioning of the product or the failure of the appliance. A device can be defined as a high-risk medical device if the failure or abnormality of the device results in the patient’s death, serious injury, or other unacceptable risk. Depending on the intended use of the product, the following product