
Sterilization Of Health Care Products - Radiation - Part 2: Establishing The Sterilization Dose
出版:British Standards Institution

专家解读视频
Describes 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].
Together with BS EN ISO 11137-1 and BS EN ISO 11137-3, it supersedes BS EN 552. Supersedes 04/30048584 DC. (07/2007) Supersedes 09/30197784 DC. (06/2015)
ISO 11137-2 : 2013(R2018) - Identical
ONORM EN ISO 11137-2:2015 - Identical
SS EN ISO 11137-2 Ed. 5 (2015) - Identical
NF EN ISO 11137-2:2015 - Identical
NEN EN ISO 11137-2:2015 - Identical
SN EN ISO 11137-2:2015 - Identical
UNE EN ISO 11137-2:2015 - Identical
EN ISO 11137-2:2015 - Identical
UNI EN ISO 11137-2:2015 - Identical