Reference number
ISO/TS 13004:2013
Technical Specification
ISO/TS 13004:2013
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Edition 1
2013-05
Withdrawn
ISO/TS 13004:2013
52320
Withdrawn (Edition 1, 2013)

Abstract

ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

General information

  •  : Withdrawn
     : 2013-05
    : Withdrawal of International Standard [95.99]
  •  : 1
     : 57
  • ISO/TC 198
    11.080.01 
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