医疗保健产品电子束辐照灭菌剂量验证中性能鉴定的实施

Implementation of performance qualification in the sterilization dose validation of health care products irradiated using electron-beam radiation

建立医疗保健产品采用电子束辐照灭菌时性能鉴定(Performancequalification,PQ)的实施方法。依据ISO11137-3:2017的基本要求,以及风险管理方法进行数据分析。建立PQ实施步骤并推荐数据处理的方法,拟为医疗保健产品采用电子束辐射灭菌时PQ的实施提供参考。

To establish an implementation method for the performance qualification of health care products that were sterilized using electron-beam radiation. Data analysis was performed in accordance with the requirements of ISO 11137-3: 2017 and risk management methods. The steps for the implementation of performance qualification were established, and data analysis methods were suggested. This paper recommendeds an implementable method of performance qualification of health care products that were sterilized using electron-beam radiation.