对GB/T 14233.2-2005修订的建议  

Proposal on Revision of GB/T 14233.2-2005

作　　者：肖佳音 李庆忠 XIAO Jiayin;LI Qingzhong(Heilongjiang Institute for Drug Control,Haerbin Heilongjiang 150088,China.)

机构地区：[1]黑龙江省药品检验研究中心,黑龙江哈尔滨150088

出　　处：《药品评价》2021年第5期277-278,共2页Drug Evaluation

摘　　要：GB/T 14233.2-2005《医用输液、输血、注射器具检验方法第2部分:生物试验方法》是我国现行的医用输液、输血、注射器具的国家推荐标准,自颁布以来,对医用输液、输血、注射器具类别的医疗器械检验具有极其重要的指导意义。本文主要结合GB/T 16886《医疗器械生物学评价》和《中国药典》标准现状及具体试验方法,对GB/T 14233.2-2005提出改进建议。GB/T 14233.2-2005 is the current national recommended standard for medical transfusion,blood transfusion and injection apparatus in China.Since its promulgation,it has played an important role in guiding the inspection of Medical Devices for medical transfusion,blood transfusion and injection apparatus.Based on the current situation of GB/T 16886 and Chinese Pharmacopoeia and specific test methods,this paper puts forward some suggestions for improvement of GB/T 14233.2-2005.

关 键 词：参考标准 内毒素类 细胞毒性试验 医疗器械 

分 类 号：R927.1[医药卫生—药学]