摘要
对自主研发的医疗器械透气包装材料微生物屏障分等试验仪器进行介绍,并对开展的仪器确认以及仪器和操作的实验室内精密度研究进行详述。研究结果表明,仪器按规定试验参数进行试验时能够完全满足试验要求。而且,该仪器的性能水平已经达到美国实验室的仪器性能水平。
To introduce the test apparatus which is developed independently for microbial barrier ranking testing of porous package materials for medical devices, and to discuss the research on apparatus validation and within-laboratory precision of the apparatus and manipulation. The research indicates that the apparatus completely meets the test requirements when testing under the approved parameters. Furthermore, the performance of the apparatus has reached a equal level comparing with the same apparatus in USA.
出处
《中国医疗器械信息》
2014年第5期30-33,共4页
China Medical Device Information
关键词
透气包装材料
微生物屏障
仪器确认
porous package material
microbial barrier
apparatus validation
