
Sterilization Of Health Care Products - Radiation - Part 2: Establishing The Sterilization Dose (Iso 11137-2:2013)
出版:Comite Europeen de Normalisation

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].
Supersedes EN 552. (07/2006) Supersedes PREN ISO 11137-2. (04/2012)
ONORM EN ISO 11137-2:2013 - Identical
SN EN ISO 11137-2:2013 - Identical
UNI EN ISO 11137-2:2013 - Identical
UNE EN ISO 11137-2:2013 - Identical
NS EN ISO 11137-2:2013 - Identical
I.S. EN ISO 11137-2:2015 - Identical
BS EN ISO 11137-2:2015 - Identical
NEN EN ISO 11137-2:2015 - Identical
SS EN ISO 11137-2 Ed. 5 (2015) - Identical
DIN EN ISO 11137-2 (2013-09) - Identical
DS EN ISO 11137-2:2013 - Identical
NF EN ISO 11137-2:2013 - Identical
NBN EN ISO 11137-2:2013 - Identical
UNI EN ISO 11137-2:2015 - Identical
UNE EN ISO 11137-2:2015 - Identical
PN EN ISO 11137-2:2015 - Identical
NF EN ISO 11137-2:2015 - Identical
ONORM EN ISO 11137-2:2015 - Identical