30.00 Aug 4, 2025
ISO
ISO/TC 198
International Standard
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
PROJECT
ISO/CD 11137-2
30.00
Committee draft (CD) registered
Aug 4, 2025
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
10.99 New project approved