RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE

ZHANG Tongcheng; ZHONG Hongliang; LIU Qingfang; MI Zhisu; WANG Chunlei

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RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE

更新时间：2023-04-07

- RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE
- Journal of Radiation Research and Radiation Processing Vol. 20, Issue 2, Pages: 103-107(2002)
- 作者机构：
  
  1.苏州大学核医学院　苏州　215007
  2.苏州大学辐照技术研究所　苏州　215007
- 作者简介：
- 基金信息：
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ZHANG Tongcheng, ZHONG Hongliang, LIU Qingfang, et al. RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE. [J]. Journal of Radiation Research and Radiation Processing 20(2):103-107(2002)
DOI：

ZHANG Tongcheng, ZHONG Hongliang, LIU Qingfang, et al. RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE. [J]. Journal of Radiation Research and Radiation Processing 20(2):103-107(2002) DOI：

摘要

按照ISO11737标准，检测了7类医疗产品的初始污染菌，范围10CFU／件—97271CFU／件；回收率54.6%—100%；校正因子1.0—1.83。并以ISO11137标准方法1完成了辐照灭菌剂量的设定。验证剂量范围为5.1—17.6kGy。取样品100件，按各验证剂量辐照，以无菌检查法评估，阳性样品数均未超过2件。所需灭菌剂量则从ISO11137标准方法附录B中表B.1外推选定。

Abstract

Bioburdens on seven kinds of medical products were determined in accordance with ISO 11737. Different data were obtained for different products. The bioburden changed from 10 cfu/device to 97271 cfu/device the recovery ratio from 54.6% to 100%,and the correcting coefficiency from 1.0 to 1.8. Based on such bioburden and method 1 of ISO 11137,the verification dose was set up for each kind of products,from 5.1 kGy to 17. 6 kGy. 100 samples were taken respectively from each kind of products and exposed to the pre — defermined verificction dose. The sterility test showed the positive number was not more than 2. Thus the sterilication dose was determined according to Table B.1 of ISO11137.

关键词

初始污染菌辐照灭菌验证剂量灭菌保证水平

Keywords

BioburdenRadiation sterilizationVerification doseSterility assurance level (SAL)

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