医疗器械消毒灭菌器械国内外分类管理探讨

On Classification Management of Disinfection and Sterilization Devices of Medical Devices at Home and Abroad

目的:为医疗器械的科学监管提供技术支撑。方法:通过对消毒灭菌器械产品原理、技术特征、预期用途的归纳,分析了该类产品的风险特征;将我国各类消毒灭菌器械的分类管理情况与美国、欧盟消毒灭菌器械的管理进行对比,分析了异同。结果与结论:对于医疗器械消毒灭菌器械,我国划分的管理类别与美国、欧盟对该类产品的管理类别一致性高,监管力度与世界发达国家基本相同。

Objective： To provide technical support for the scientific supervision of the medical devices. Methods： Through analyzing the principle, technical characteristics and intended use of the disinfection and sterilization device products, the risk characteristics of such products were analyzed. The classification management of various disinfection and sterilization devices in China was compared with the management of disinfection and sterilization devices in the United States and the European Union, meanwhile, the similarities and differences were analyzed. Results and Conclusion： The classification management of the disinfection and sterilization devices of China is highly consistent with that of the United States and the European Union. The regulatory level is basically the same as that of the developed countries in the world.