EVS-EN ISO 11137-2:2015+A1:2023

ISO 11137-2 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility. It also provides 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 describes methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This standard defines product families for sterilization dose establishment and sterilization dose audit.

This consolidated version consists of the main text and the amendment, which can also be found separately from the standards history.

In the amendment you can find:

— Annex ZA, which describes the relationship between ISO 11137-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/745

— Annex ZB, which describes the relationship between ISO 11137-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/746