云南省一次性使用无菌注射器质量监督抽验情况分析  

Analysis and Study the Quality Monitoring Sampling Results of Sterile Hypodermic Syringes for Single Use

作　　者：黄勇 李子堃 孙磊 HUANG Yong, LI Zi-kun, SUN Lei （Yunnan Province Institute for Medical Equipment Testing, Kunming 650034,China ）

机构地区：[1]云南省医疗器械检验所,云南昆明650034

出　　处：《医学信息》2011年第15期5023-5024,共2页Journal of Medical Information

摘　　要：目的对云南省6年来一次性使用无菌注射器的质量监督抽验情况进行分析探讨。方法按照GB15810—2001《一次性使用无菌注射器》和GB15811—2001《一次性使用无菌注射针》所述方法进行外观、滑动性能、器身密合性、容量允差、残留容量、易氧化物、无菌、热原、针尖外观、注射针韧性、连接牢固度、针尖穿刺力等12个项目的检测。结果2005年-2010年的抽验合格率分别为：85．7％、83．9％、90．0％、90．9％、92.3％、96．9％。不合格的主要问题集中在产品的物理性能方面：如器身密合性、滑动性能、针尖穿刺力等。结论应加强对一次性使用无菌注射器的监管，加大对不合格企业的抽捡力度，确保在临床上的安全使用。Objectives Analysis and study the quality monitoring sampling results of sterile hypodermic syringes for single use organized by the Yunnan Provincial Food and Drag Administration in recent 6 years. Methods carried out the 12 test items described in the GB15810-2001（sterile hypodermic syringes for single use） and GB15811-2001 （sterile hypodermic needles for single use ）, including appearance, forces required to operate plunger, liquid leakage at syringe piston under compression, tolerance on graduated capacity, dead space, readily oxidizable substances, sterility, pyrogens, appearance of needlepoint, tenacity of injector needle, fastness of the link, needle puncture ability, etc. Results qualified ratio of the samples from 2005 to 2010 is 85.7%, 83.9%, 90.0% ,90.9% ,92.3% ,96.9% respectively which is lower than the same period of the State. Failure items focus on the physical functions such as liquid leakage at syringe piston under compression, forces required to operate plunger and needle puncture ability. Conclusion Monitoring and management of sterile hypodermic syringes for single use should be improved, increase the sampling frequency to the unqualified enterprises to ensure safe usage of the one-off sterile syringe in the clinical duration.

关 键 词：一次性使用无菌注射器 监督 抽验 

分 类 号：R951[医药卫生—药学]