Study on irradiation sterilization of medical gauze pad by incremental dosage method

LEI Qing; HUANG Min; DENG Wenmin; WU Ling; WANG Yan; GAO Peng; DU Xiaoying; XIE Yan

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Study on irradiation sterilization of medical gauze pad by incremental dosage method

更新时间：2023-03-27

- Study on irradiation sterilization of medical gauze pad by incremental dosage method
- Journal of Radiation Research and Radiation Processing Vol. 29, Issue 2, Pages: 89-92(2011)
- 作者机构：
  
  1.四川省原子能研究院　成都　610066
- 作者简介：
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LEI Qing, HUANG Min, DENG Wenmin, et al. Study on irradiation sterilization of medical gauze pad by incremental dosage method. [J]. Journal of Radiation Research and Radiation Processing 29(2):89-92(2011)
DOI：

LEI Qing, HUANG Min, DENG Wenmin, et al. Study on irradiation sterilization of medical gauze pad by incremental dosage method. [J]. Journal of Radiation Research and Radiation Processing 29(2):89-92(2011) DOI：

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。

Abstract

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.

关键词

医用脱脂纱布垫辐射灭菌增量剂量验证剂量

Keywords

Medical gauze padIrradiation sterilizationIncremental dosageVerification dose

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RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE

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School of Nuclear Medicine, Soochow University

Institute of Radiation Technique, Soochow University

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