AAMI TIR27 : 1ED 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 the Advancement of Medical Instrumentation
专家解读视频
基本信息
标准编号： AAMI TIR27 : 1ED 2001
标准类别：Standard
出版单位：Association for the Advancement of Medical Instrumentation
标准页数：0
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.
等同采用的国际标准
ISO 11137 : 1995 - Identical
