Mambretti C
Assobiomedica, Milan, Italy.
Ann Ist Super Sanita. 1995;31(1):109-12.
The primary objectives which the European directive proposal wants to reach are: a) to guarantee a high quality standard of the products which are put into the EC market, for the user; b) to guarantee the safety and health of the user and of all other people who come into direct contact with the said products. The directives define a precise scheme of regulation and control for all medical devices and this scheme is in force for all the member states of European Union.
a) 为用户确保投放至欧盟市场的产品具有高质量标准；b) 确保用户以及所有直接接触上述产品的其他人的安全与健康。这些指令为所有医疗设备定义了精确的监管和控制方案，且该方案在欧盟所有成员国均有效。
