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EVS-EN ISO 11137-2:2013

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

General information
Withdrawn from 02.07.2015
Base Documents
ISO 11137-2:2013; EN ISO 11137-2:2013
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.07.2015
Main
05.08.2013
Main
Main
EVS-EN ISO 11137-2:2012
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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EVS-EN ISO 11137-1:2006/A1:2013

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EVS-EN ISO 10993-10:2013

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Main

EVS-EN 556-1:2002

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Newest version Valid from 06.05.2002
Amendment

ISO 11137-1:2006/Amd 1:2013

ISO 11137-1:2006 - Amendment
Newest version Valid from 16.07.2013