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EVS-EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

General information
Valid from 02.07.2015
Base Documents
ISO 11137-2:2013; EN ISO 11137-2:2015

Standard history

Status
Date
Type
Name
02.05.2023
Amendment
02.05.2023
Main + amendment
02.07.2015
Main
05.08.2013
Main
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.

The text of ISO 11135:2014 has been approved in Europe as EN ISO 11137-2:2015 without any changes.
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