Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

ISO/TS 13004:2013

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

May 6, 2013
95.99   Withdrawal of Standard   Oct 7, 2022

General information

95.99     Oct 7, 2022

ISO

ISO/TC 198

Technical Specification

11.080.01  

English  

Buying

Withdrawn

Language in which you want to receive the document.

Scope

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.

Life cycle

NOW

WITHDRAWN
ISO/TS 13004:2013
95.99 Withdrawal of Standard
Oct 7, 2022

REVISED BY

PUBLISHED
ISO 13004:2022

National adoptions

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

95.99   Withdrawal of Standard

Z076 more