一次性使用电子镇痛输注泵环氧乙烷灭菌效果验证

Validation of ethylene oxide sterilization of disposable electronic analgesia infusion pumps

【目的】验证环氧乙烷对一次性使用电子镇痛输注泵灭菌工艺的有效性及残留量是否符合要求。【方法】按照ISO 11135:2014《医疗保健产品灭菌环氧乙烷医疗器械灭菌工艺的设定、确认和常规控制的要求》要求对一次性使用电子镇痛输注泵进行物理和微生物循环性能合格性验证,进行无菌试验灭菌效果验证,并按照ISO 10993⁃7:2008《医疗器械生物学评价第7部分:环氧乙烷灭菌残留量》测定残留的环氧乙烷含量。【结果】在温度为38.0~45.4℃,湿度为46%~81%物理条件下可达到灭菌要求;当温度低于35℃且相对湿度高于71%时,菌片在经过环氧乙烷灭菌后仍具有充分的复活能力;暴露于环氧乙烷后无生物指示剂生存的最短时间为8 h;灭菌后环氧乙烷残留量低于最低检测限。【结论】所有验证产品均能被灭菌,灭菌设备和灭菌过程均符合ISO 11135:2014所规定指标要求,灭菌环氧乙烷残留量符合ISO 10993⁃7:2008限值要求。

[Introduction]To validate the effect of ethylene oxide sterilization of disposable electronic analgesia infusion pumps and determine the residual amount.[Methods]According to ISO 11135:2014 Sterilization of Healthcare Products⁃Ethylene Oxide⁃Requirements for the Development,Validation and Routine Control of Sterilization Process for Medical Devices,qualification of physical cycle performance and microbial cycle performance were conducted on disposable electronic analgesia infusion pumps,and sterilization effect was then validated by using sterility test.According to ISO 10993⁃7:2008 Biological Evaluation of Medical Devices—Part 7:ethylene oxide sterilization residuals,the residual amount of ethylene oxide were further measured.[Results]The sterilization effect fulfilled the requirements under the physical conditions of 38.0‒45.4℃and 46%‒81%humidity.When the temperature was lower than 35℃and the humidity was higher than 71%,the bacterial tablets remained fully activated after the sterilization with ethylene oxide.The shortest survival time without biological indicator after exposure to ethylene oxide was 8h.Furthermore,the residual amount of ethylene oxide after the sterilization was lower than the minimum detection limit.[Conclusion]All tested products are sterilized.Sterilization equipment and sterilization process fulfilled the requirements of ISO 11135:2014.Additionally,the sterilization residual amount conforms to the limit values of ISO 10993⁃7:2008.