摘要
探索医疗用品灭菌剂量设定方法,依据国际标准ISO11137第二部分的方法2A来设定医疗产品的辐射灭菌剂量。以医用脱脂纱布垫为实验材料,用增量剂量方法及一系列公式先设定验证剂量,再通过验证剂量实验确定灭菌保证水平(SAL)达到10-6的灭菌剂量,最终确定的医用脱脂纱布垫的灭菌剂量为29.7 kGy。该实验为需要采用国际标准ISO11137第二部分的方法2A来设定医疗器械的灭菌剂量提供了参考。
To explore the sterilization dose setting method for medical products,the irradiation sterilization dose for medical products was set according to the method 2A of international standard ISO11137 Part 2.The verification dose for medical gauze pad by was set by incremental dose method and with a series of formula.Then the sterilization dose for an SAL of 10-6 was established by completing the verification dose experiment.The final sterilization dose for medical gauze pad was decided to be 29.7 kGy.This study gives reference for the setting irradiation sterilization dose for medical products which need to adopt the method 2A of international standard ISO11137 Part 2.
出处
《辐射研究与辐射工艺学报》
CAS
CSCD
2011年第2期89-92,共4页
Journal of Radiation Research and Radiation Processing
基金
四川省科技计划项目(2008SG0029)资助
关键词
医用脱脂纱布垫
辐射灭菌
增量剂量
验证剂量
Medical gauze pad
Irradiation sterilization
Incremental dosage
Verification dose
