ISO/TS 13004:2013
Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VDmax<(hoch)SD>
- Standard No.
- ISO/TS 13004:2013
- Release Date
- 2013
- Published By
- International Organization for Standardization (ISO)
- Latest
- ISO/TS 13004:2013
- 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.
ISO/TS 13004:2013 Referenced Document
- ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
- ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*， 2019-12-02 Update
ISO/TS 13004:2013 history
- 2013 ISO/TS 13004:2013 Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>
