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.

CONTENT PROVIDER
International Organization for Standardization [iso]

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