CSA Group Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD ISO/TS 13004:2013

Description
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.
  • Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD - ISO/TS 13004:2013 - CSA Group
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Description
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.

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Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD - ISO/TS 13004:2013 - CSA Group
CSA Group
Toronto, Ontario, Canada
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
ISO/TS 13004:2013
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD ISO/TS 13004:2013
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.

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.

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  CSA Group
Product Category Standards and Technical Documents
Product Number ISO/TS 13004:2013
Product Name Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
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