
Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
出版:International Organization for Standardization

专家解读视频
Gives a method of substantiating the suitability of 25 kgyas a sterilization dose for radiation sterilization ofproducts with an average bioburden of less than 1 000colony-forming units (cfu) that are manufactured in smallquantities (less than 1 000 product Units).
NEN NPR ISO/TS 13409:2002 - Identical
AAMI ISO TIR 13409:1996 - Identical
NEN NPR ISO/TS 13409 : 2002 - Identical
AAMI ISO TIR 13409 : 1996 ERRATA 2005 - Identical
NEN NPR ISO/TS 13409 : 2002 - Identical
AAMI ISO TIR 13409 : 1996 ERRATA 2005 - Identical