Application of statistical process control in medical devices quality control of electron beam irradiation sterilization
“The monitoring of irradiation sterilization dose of medical devices adopts statistical process control method, which helps to timely detect abnormal fluctuations, control the stability of sterilization process, and ensure stable and reliable product quality.”
Journal of Radiation Research and Radiation ProcessingVol. 38, Issue 1, Pages: 57-62(2020)
作者机构:
1. 山东威高集团医用高分子制品股份有限公司 威海 264200
2. 利洁时集团 青岛 266000
3. 威海市技术监督信息研究所 威海 264200
作者简介:
YUE Fangming (female) was born in January 1985, and obtained her master’s degree from Shandong University in 2016. Now she works at Shandong Weigao Group Medical Polymer Products Co., Ltd. as a quality management senior engineer. E-mail: 59703732@qq.com
YUE Fangming,LI Tingting,SUN Kaifeng,et al.Application of statistical process control in medical devices quality control of electron beam irradiation sterilization[J].Journal of Radiation Research and Radiation Processing,2020,38(01):57-62.
YUE Fangming,LI Tingting,SUN Kaifeng,et al.Application of statistical process control in medical devices quality control of electron beam irradiation sterilization[J].Journal of Radiation Research and Radiation Processing,2020,38(01):57-62. DOI: 10.11889/j.1000-3436.2020.rrj.38.010701.
Application of statistical process control in medical devices quality control of electron beam irradiation sterilization