Determination, statistics, and analysis of initially contaminated microorganisms on medical devices treated by γ-radiation sterilization

CONG Lihong; ZHU Nankang; TENG Weifang

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Determination, statistics, and analysis of initially contaminated microorganisms on medical devices treated by γ-radiation sterilization

更新时间：2023-03-30

- Determination, statistics, and analysis of initially contaminated microorganisms on medical devices treated by γ-radiation sterilization
- Journal of Radiation Research and Radiation Processing Vol. 27, Issue 6, Pages: 374-376(2009)
- 作者机构：
  
  1.苏州大学辐照技术研究所　苏州　215200
- 作者简介：
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CONG Lihong, ZHU Nankang, TENG Weifang. Determination, statistics, and analysis of initially contaminated microorganisms on medical devices treated by γ-radiation sterilization. [J]. Journal of Radiation Research and Radiation Processing 27(6):374-376(2009)
DOI：

CONG Lihong, ZHU Nankang, TENG Weifang. Determination, statistics, and analysis of initially contaminated microorganisms on medical devices treated by γ-radiation sterilization. [J]. Journal of Radiation Research and Radiation Processing 27(6):374-376(2009) DOI：

摘要

为了解医疗器械生产企业的γ辐射灭菌产品初始污染菌的分布状况，采用ISO11737-1 2006方法对620批次产品进行了检测统计。结果显示，初始污染菌（cfu/件）范围≤1.5的占7.9%、1.5～100（包括100）的占43.5%、100～1000（包括1000）的占26.0%、1000～10000的占18.2%、10000以上的占4.4%，这些结果为γ辐射灭菌的剂量设定和产品质量稳定性提供了有益参考。

Abstract

In order to investigate the influence of initially contaminated microorganisms on medical devices for treatment by γ-radiation sterilization, 620 batches of products collected from more than 50 manufactures in Jiangsu, Zhejiang, Shanghai and so on have been inspected by use of ISO11737-1 2006 sterilization of medical devices-microbiological methods-Part 1. The results show that the product batches share is 7.9%, 43.5%, 26.0%, 18.2% and 4.4% with an average bioburden of ≤1.5, 1.5~100, 100~1000, 1000~10000 and >10000 cfu/piece, respectively. These data are helpful to the dose decision for γ-radiation sterilization and quality stability of medical product.

关键词

γ辐射灭菌医疗器械初始污染菌灭菌剂量

Keywords

γ-radiation sterilizationMedical devicesBioburdenSterilization dose

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