Standard

ISO/TS 13004:2013

May 2013 Withdrawn

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Abstract

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.

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Standard from ISO
Published: May 6 2013
Withdrawn: October 7 2022
Edition: 1
Document type: TS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.080.01
International TC: ISO/TC 198

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Revised by: ISO 13004:2022

ISO/TS 13004:2013

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Abstract

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Product life cycle