摘要
本文对医疗器械辐射灭菌剂量验证所涉及到的国内外标准进行了系统的研究,并针对标准中的相关要求给生产企业提出检验建议。
The situation of medical device sterilization validation of gamma irradiation standard system at home and abroad was studied in this paper, and we make some suggestions for producer according to the standard.
出处
《中国医疗器械信息》
2015年第9期42-44,60,共4页
China Medical Device Information
关键词
医疗器械
辐射灭菌剂量验证
标准体系
检验建议
medical device,sterilization validation of gamma irradiation,standard system,testing suggestions