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
Reference number
ISO/TR 13409:1996
Edition 1
1996-12
© ISO 2024
Withdrawn
Withdrawn (Edition 1, 1996)

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     : Withdrawn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
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 19
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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