Journal of Radiation Research and Radiation Processing ›› 2019, Vol. 37 ›› Issue (3): 9-030901-4.doi: 10.11889/j.1000-3436.2019.rrj.37.030901

• SHORT PAPER • Previous Articles    

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

ZUO Duwen1(),LI Qian2,ZHU Nankang1,3   

  1. 1. Wujiang Dasheng Detection Technology Co. , Ltd. Wujiang 215214, China
    2. Jiangsu Dasheng & Rumbia Bio-tech Co. , Ltd. Wujiang 215214, Chian
    3. Institute of Radiation Technique of Soochow University, Wujiang 215200, China
  • Received:2018-11-20 Revised:2018-12-24 Accepted:2018-12-24 Online:2019-06-20 Published:2019-06-18
  • About author:ZUO Duwen (male) was born in January 1985, and obtained his master’s degree of light chemical engineering from Suzhou University in 2010. Now he works at Wujiang Dasheng Detection Technology Co., Ltd, as an engineer, E-mail:Harvey_zuo@foxmail.com

Abstract:

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.

Key words: Electron-beam radiation, Health care products, Performance qualification

CLC Number: 

  • TL99