CEN ISO/TS 13004:2014

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

WITHDRAWN

About this standard

Languages
German and English
Type
NBN
Standards committee
CEN/TC 204
Status
WITHDRAWN
Publication date
01 May 2014
Replaced by
NBN EN ISO 13004:2023
ICS Code
11.080.01 (Sterilization and disinfection in general)
Withdrawn Date
28 June 2023
Price
€ 50,00

About this training

Summary

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.