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doi:10.11889/j.1000-3436.2014.rrj.32.050204

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- Journal of Radiation Research and Radiation Processing Vol. 32, Issue 5, Pages: 5-050204(2014)
- 作者机构：
  
  1. 南京航空航天大学
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- DOI：10.11889/j.1000-3436.2014.rrj.32.050204
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[J]. Journal of Radiation Research and Radiation Processing 32(5):5-050204(2014)
DOI：

[J]. Journal of Radiation Research and Radiation Processing 32(5):5-050204(2014) DOI： 10.11889/j.1000-3436.2014.rrj.32.050204.

摘要

随着核技术产业的日益发展，辐照灭菌已经成为了国际上医疗保健产品普遍采用的灭菌方式。但是按照国际标准ISO11137-2: 2013的要求对医疗保健产品进行辐照灭菌剂量设定时，选择合适的灭菌剂量设定方法和实验过程仍存在一定的难度。本文将ISO11137-2: 2013标准中的灭菌剂量设定方法和实验过程按照5个关键性差异因素分成12个子类别，并制作成“灭菌剂量设定方法筛选表”。该筛选表作为一种灭菌剂量设定方法的选择策略，可以协助相关工作人员迅速准确地对一个新的医疗保健产品选择其合适的灭菌剂量设定方法，并制订相应的实验过程。

Abstract

With the development of nuclear technology industry, irradiation sterilization has become an interna-tionally used sterilization method for health care products. But it is difficult to choose the appropriate methods and procedures of radiation sterilization dose setting for health care products by using international standard ISO11137-2: 2013. The sterilization dose setting methods and procedures in ISO11137-2: 2013 are divided into 12 sub categories according to 5 key factors of difference and based on which the screening table of sterilization dose setting methods is developed. The screening table can help users to make a quick and appropriate choice when dealing with sterilization dose setting method choosing problem for a brand new health care product and find the corresponding experimental procedures.Cited

关键词

辐照灭菌剂量设定方法选择策略筛选表

Keywords

Radiation sterilizationDose setting methodsStrategy of choosingScreening table

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DOI：10.11889/j.1000-3436.2014.rrj.32.050204

摘要

Abstract

关键词

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