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空气排除与蒸汽渗透测试方法 被引量:1

Air removal and steam penetration test
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摘要 目的介绍对蒸汽灭菌器进行空气排除和蒸汽渗透测试的方法,验证所使用的蒸汽灭菌器具备达到规定无菌水平的能力。方法分析并比较相关国际、国家、医药行业标准,按负载类型测试方法分为BD类测试和空腔负载测试,对测试方法所使用的化学指示物等进行详细阐述。结果 BD类测试和空腔负载测试共同构成了较为全面的空气排除和蒸汽渗透性能测试,对预真空蒸汽灭菌器的性能作出合理评价,保证了灭菌物品的无菌保证水平。结论这些测试方法可用于指导灭菌处理人员的实际工作,控制医院感染。 OBJECTIVE To introduce the test methods for air removal and steam penetration,which can be used to make sure the steam sterilizers in good condition to fill the requirements of SAL. METHODS We made the analysis and comparison of related international standards and found that these were bowie and dick-type test and Hollow load test according to the load processed by the steam sterilizers.national standards and pharmaceutical industry standards,explained the details of chemical indicators that used in test. RESULTS Bowie and Dick-type test and hollow test together formulated an integrated performance test of air removal and steam penetration,which could made a reasonable evaluation of the performance of steam sterilizer so as to ensure the aseptic level of sterilized items. CONCLUSION We suggest that the test methods can be used for the personnel deal with the sterilization work to precaution and control infection.
出处 《中华医院感染学杂志》 CAS CSCD 北大核心 2011年第22期4750-4752,共3页 Chinese Journal of Nosocomiology
关键词 化学指示物 BD类测试 空腔负载测试 过程挑战装置 Chemical indicators Bowie and Dick-type test Hollow load test Process challenge devices
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参考文献10

  • 1ANSI/AAMI ST46 2002 : Good Hospital Practice:Steam Sterilization and Sterility Assurance[S]. ANSI/AAMI, 2002.
  • 2.消毒技术规范[S].[S].中华人民共和国卫生部,2002,11..
  • 3European Committee for standaization. EN 285: 2006 + A2 Sterilization-Steam sterilizers Large sterilizers [S]. CEN, 2009.
  • 4中华人民共和国国家质量监督检验检疫总局,中国国家标准化管理委员会.ISO11140-3:医疗保健产品灭菌化学指示物第3部分:用于BD类蒸汽渗透测试的二类指示物系统[S].北京:中华人民共和国国家质量监督检验检疫总局,2009.
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  • 9European Committee for standaization. Sterilization-Steam sterilizers-Large sterilizers. EN867-5 : Non-biological systems for use in sterilizers-Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S[S]. CEN,2001.
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