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医疗器械的γ射线消毒原理与工艺探讨
摘 要
随着当今社会医疗水平的不断提高,无菌医疗器械特别是无菌手术器械的使用数量也不断上升,因此,高效率的灭菌方法日益成为众多医疗器械厂家生产过程中关注的焦点。钴60-γ射线灭菌法具有穿透力强、灭菌均匀彻底、可在常温下进行、可连续作业等显著特点被越来越多的医疗器械的生产厂家所使用。
本文主要从钴60-γ射线灭菌原理与工艺流程两个方面介绍了射线灭菌的整个流程,对γ射线灭菌的特点进行了说明,并对灭菌装置进行了具体的介绍。本文的主要目的是让从事医疗器械灭菌方面的人员对γ射线的灭菌原理与流程有更好的了解。在选择消毒灭菌的方式时,根据自身产品的特点,正确合理选择。另外,本文对辐射灭菌验证以及辐射灭菌的操作过程进行了详细的描述,对灭菌过程中的所应注意的内容也给出了说明,对从事辐射灭菌操作的相关人员提供了参考。
关键词:医疗器械; γ射线 ; 辐射灭菌
The Principles and Process of γ-ray sterilization of medical devices
Abstract
With the increasing levels of today’s social care system, the number of sterile medical devices in particular the sterilized surgical instruments has been increasing, therefore, highly efficient method of sterilization is increasingly becoming the point of many medical device company focus on. Cobalt 60-γ-ray sterilization method, which has the penetrating power, even thorough sterilization can be carried out at room temperature, continuous operations, and other notable features, are becoming more and more popular among the medical device manufacturers.
This article introduce the Cobalt-60-γ ray sterilization process in both theory and practice of the γ-ray sterilization process, and describe the characteristics of the γ-ray sterilization and the sterilization apparatus. The main purpose of this paper is to provide the personnel, who are engaged in the aspects of medical device sterilization with a better understanding of the γ-ray sterilization principles and processes. They can make correct and reasonable choice, according to the characteristics of their product itself, when they need to choose the way of sterilization. In addition, this article provided not only a detailed description of the radiation sterilization verification and the sterilization process, but also the description of the content that should be noted during the operation of sterilization process, which will work as a reference for the people worked in the relevant radiation sterilization.
Keywords: medical device; γ-ray;
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