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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
Amendment
EN ISO 11137-2:2015/prA1
02.07.2015
Main
05.08.2013
Main
This part of ISO 11137 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. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.
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