1857597

ISO/TS 13004:2013 [ Withdrawn ]

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

standard by International Organization for Standardization (Technical Standard) , 04/30/2013

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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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Published:
04/30/2013
File Size:
1 file , 860 KB
Same As:
BS PD ISO/TS 13004:2013, BS PD CEN ISO/TS 13004:2014
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This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. ISO 13004:2022


    Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

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  2. ISO/TS 13004:2013

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    Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

    • Historical Version