Norm

CEN ISO/TS 13004:2014 en

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

147,90

Over deze norm

Status Definitief
Aantal pagina's 57
Gepubliceerd op 01-06-2014
Taal Engels
CEN ISO/TS 13004 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. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

Details

ICS-code 11.080.01
Engelse titel Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

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