
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
出版:International Organization for Standardization

专家解读视频
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].
ANSI/AAMI/ ISO 11137-2: 2013(R2019) - Identical
SS-EN ISO 11137-2:2015 - Identical
PN EN ISO 11137-2 : 2015 - Identical
DS EN ISO 11137-2 : 2015 - Identical
UNI EN ISO 11137-2:2015 - Identical
GOST ISO 11137-2 : 2011 - Identical
AAMI ISO 11137-2 : 2013 - Identical
CSA ISO 11137-2 : 2016 - Identical
GOST R ISO 11137-2 : 2008 - Identical
CSA Z11137-2 : 2007 : R2012 : FR - Identical
SANS 11137-2 : 1ED 2007(R2009) - Identical
CSA Z11137-2 : 2007 : R2012 - Identical
CSA Z11137-2 : 2007 - Identical
CSA Z11137-2 : 2007 - Identical
NBR ISO 11137-2 : 2015 - Identical