Abstract

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.


General information 

  • Status
     : Withdrawn
    Publication date
     : 1996-12
  • Edition
     : 1
    Number of pages
     : 19
  • Technical Committee
     : ISO/TC 198 Sterilization of health care products
  • ICS
     :
    11.080.01 Sterilization and disinfection in general

Life cycle

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