ISO/TS 13004:2013 PDF
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Open preview (PDF)Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSDTitle (English):
ISO/TS 13004:2013
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 57
- Publication date:
- May 6, 2013
- Edition:
- ISO TS 13004 edition 1 version 1
- ICS:
- 11.080.01
Description (English):
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.
Technical details
- Technical committee
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO/TS 13004:2013
