AAMI TIR27 Ed. 1 (2001)被替代
Sterilization Of Health Care Products - Radiation Sterilization - Substantiation Of 25 Kgy As A Sterilization Dose - Method Vd Max
出版：Association for Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI TIR27 Ed. 1 (2001)
发布时间：2001/10/9 0:00:00
标准类别：Standard
出版单位：Association for Advancement of Medical Instrumentation
标准页数：15
标准简介
Defines a method of substantiation of 25 kGy as the sterilization dose for radiation sterilization of health care products with an average bioburden for the entire product unit (SIP=1) < 1000 colony-forming units (cfu). Application of the method of substantiation of 25 kGy described in this technical report may be used to meet the requirements specified under subclause 6.2.2 relating to product qualification in ISO 11137.
替代本标准的新标准
等同采用的国际标准
ISO 11137:1995 - Identical
