深度解析在用Ⅱ级生物安全柜现状

Depth Resolution at Level with Ⅱ Biological Safety Cabinet

自2016年2月起国家食品药品监督管理总局发布实施《医疗器械使用质量监督管理办法》,同年8月份北京市食品药品监督管理局和北京市卫计委联合发布《生物安全柜在用医疗器械质量控制技术要求》。两项举措都是为了进一步规范和加强在用医疗器械质量管理,保证医疗器械使用的安全、有效。下面就影响在用Ⅱ级生物安全柜产品质量的诸多问题进行深度解析。

Since February 2016,the State Food and Drug Administration enforcement of the state administration of“Quality Supervision And Management of the Medical Devices Are Method”,in the same year in August,the Beijing Municipal Food and Drug Administration and the Beijing Health Planning Commission jointly issued the“Biological Safety Cabinet in Medical Equipment Quality Control Technical Requirements”.Both measures are designed to further standardize and strengthen the quality management of medical devices to ensure the safe and effective use of medical devices.The following effects on level withⅡbiological safety cabinet product quality problems in-depth analysis.