Research on determination of bio-burden for radiation sterilization of health care products

LIU Qinfang

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Research on determination of bio-burden for radiation sterilization of health care products

更新时间：2023-03-30

- Research on determination of bio-burden for radiation sterilization of health care products
- Journal of Radiation Research and Radiation Processing Vol. 26, Issue 1, Pages: 57-60(2008)
- 作者机构：
  
  1.苏州大学放射医学和公共卫生学院　苏州215123
- 作者简介：
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LIU Qinfang. Research on determination of bio-burden for radiation sterilization of health care products. [J]. Journal of Radiation Research and Radiation Processing 26(1):57-60(2008)
DOI：

LIU Qinfang. Research on determination of bio-burden for radiation sterilization of health care products. [J]. Journal of Radiation Research and Radiation Processing 26(1):57-60(2008) DOI：

摘要

对全国52个厂家的148种不同出口医疗器械产品进行初始污染菌检测技术的研究，为辐照剂量设定提供微生物参数。对148种医疗器械进行微生物培养条件、洗脱技术、校正因子、细菌总数检测技术的选择和验证。建立了不同生物负载水平频数分布图，验证了五种洗脱技术的洗脱能力。初始污染菌检测技术研究能为医疗产品辐照剂量设定提供精确的微生物信息。

Abstract

In order to provide data of bio-burden for dose setting in radiation sterilization, determination of bio-burden on 148 kinds of health care products from 52 manufacturers were carried out. The culture of microorganisms, different elution technology, and correction coefficient of the microbiological methods have been used for determination of bio-burden. Frequent distribution of bio-burden was established. 5 kinds of elution processes were checked. Actual data of bio-burden for dose setting in radiation sterilization was gotten.

关键词

辐射灭菌初始污染菌剂量设定

Keywords

Radiation sterilizationBio-burdenDose setting

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