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.
Status: WithdrawnPublication date: 1996-12
Edition: 1Number of pages: 19
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.01 Sterilization and disinfection in general
ISO/TR 13409:1996Stage: 95.99
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