摘要
过程挑战装置(PCD)广泛应用于灭菌过程有效性的评价中,当PCD被用来评价特定的灭菌过程的有效性时,应对其本身的可靠性进行验证。本文主要介绍了国内外对蒸汽灭菌过程挑战装置有效性验证的研究现状,简述国内相关标准的内容。
The process challenge device(PCD)is widely used in the evaluation of the effectiveness of the sterilization process.When PCD is used to evaluate theeffectiveness of a particular sterilization process,its reliability should be verified.This paper mainly introduces the research status of the verification of theeffectiveness of PCDs used in the steam sterilization process at home and abroad,and briefly describes the contents of the relevant domestic standards.
作者
龚琬玲
邱纬宇
GONG Wan-ling;QIU Wei-yu(Guang dong Medical Devices Quality Surveillance and Test Institute,Guang dong Guangzhou 510663)
出处
《中国医疗器械信息》
2017年第12期19-20,共2页
China Medical Device Information
关键词
过程挑战装置
蒸汽灭菌
process challenge device
steam sterilization