Med Device Technol. 2006 Apr;17(3):23-4.
A new statistical process control method for gamma and electron-beam sterilisation processes has been established to meet new requirements to take measurement uncertainty into account when product is released. The method, outlined here, uses probability-based data to determine the appropriate target dose for each type of product and thereby avoid unnecessary product rejections.
已建立一种用于伽马和电子束灭菌过程的新统计过程控制方法,以满足在产品放行时考虑测量不确定度的新要求。此处概述的该方法使用基于概率的数据来确定每种产品类型的合适目标剂量,从而避免不必要的产品拒收。