ISO/TS 13004:2013

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

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.

OEN:

ISO

Langue:

English

Code(s) de l'ICS:

11.080.01

Statut:

Annulée

Date de Publication:

2013-05-05

Numéro Standard:

ISO/TS 13004:2013