Standard

SN-CEN ISO/TS 13004:2014

Withdrawn

Corrigenda and amendments are bought separately.

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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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2014-05
  • Version: 1
  • Document type: TS
  • ICS 11.080.01
  • National Committee CEN/TC 204

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