Historical
ISO/TR 13409:1996
Sterilization of health care products -- Radiation sterilization -- Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
Describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of health care products with an average bioburden of less than 1 000 colony forming units (cfu), that are manufactured in small quantities.
International Organization for Standardization [iso]