NEN - NPR-ISO/TS 13004
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD[max]SD
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 1 May 2013 |
| Status: | inactive |
| Page Count: | 66 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
This Technical Specification 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.
Document History
NPR-ISO/TS 13004
May 1, 2013
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD[max]SD
This Technical Specification 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...