ANSI/AAMI/ ISO 11137-2: 2013(R2019)現行
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
出版：Association for the Advancement of Medical Instrumentation
專家解讀視頻
基本信息
標準編號： ANSI/AAMI/ ISO 11137-2: 2013(R2019)
標準類別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
標準頁數：0
標準簡介
Describes methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10[-6].
本標準替代的舊標準
等同采用的國際標準
ISO 11137-2 : 2013(R2018) - Identical
