Abstract

Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.


General information 

  • Status
     : Withdrawn
    Publication date
     : 1995-03
  • Edition
     : 1
    Number of pages
     : 61
  • 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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