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ECLASS BASIC 14.0 (cn) ECLASS BASIC 14.0 (cn)

Classification: 34000000 [AAD111010]

Preferred name 34 医疗产品
Definition 医疗产品(MP)是指所有单独使用或连接使用的仪器、设备、器具、软件、材料或其他物品,包括制造商为诊断和/或治疗目的而设计的应用软件,以及 MP 软件正常运行所必需的软件。制造商确定的用于人类的目的是:诊断、预防、监测、治疗或缓解疾病,诊断、监测、治疗、缓解或补偿损伤或残障,调查、更换或修改解剖结构或生理过程,节育及其在人体中或在人体上通过药理学、免疫学或资金的主要预期作用,也不是通过新陈代谢实现的,其操作可以通过这些手段支持。医疗设备附件是指本身不一定是医疗设备,但由于制造商特别规定的预期用途而与医疗设备一起使用的产品。
IRDI 0173-1#01-AAD111#010
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