摘要
从六个方面分析了医疗器械生产质量管理规范检查中发现的微生物检验问题,旨在针对相关问题进行改正,提高医疗器械生产企业的微生物检验能力,确保微生物检验结果的可靠性与准确性。
Analyzed from six aspects of microbiological test problems found during the inspection of good manufacturing practice for medical devices.Aimed at the related problems are corrected,improve the microbiological test ability of medical device manufacturers,ensure the reliability and accuracy of microbiological test results.
作者
陈靖云
卢昕
胡美丽
CHEN Jing-yun;LU Xin;HU Mei-li(Zhejiang Institute of Medical Device Supervision and Testing,Key Laboratory of Safety Evaluation of Medical Device of Zhejiang Province,NMPA Key Laboratory for Biomedical Optics,Zhejiang Hangzhou 310018)
出处
《中国医疗器械信息》
2022年第3期14-16,共3页
China Medical Device Information
关键词
医疗器械
规范检查
微生物检验
medical device
GMP inspection
microbiological test
