
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
出版:Standardiserings-Kommissionen I Sverige

專家解讀視頻
This part of ISO 11137 specifies methods for 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.