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ISO 11137-2:2013

May 2013 Current

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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1 Current ISO 11137-2:2013/Amd 1:2022 Amendment from Publication date: Jun 2022 Pages: 2 Language: English, French Services: Online, Online + Pdf

Abstract

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.

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Standard from ISO
Published: May 21 2013
Edition: 3
Document type: IS
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ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.080.01
International TC: ISO/TC 198

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Adopted by: NF EN ISO 11137-2:2015
Adopted by: SN EN ISO 11137-2:2015
Adopted by: NF EN ISO 11137-2:2013
Adopted by: SN EN ISO 11137-2:2013
Revises: ISO 11137-2:2012

ISO 11137-2:2013

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ISO 11137-2:2013

ISO 11137-2:2012

ISO 11137-2:2006

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Version history Related Corrigenda and Amendments (1)

ISO 11137-2:2013/Amd 1:2022

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ISO 11137-2:2013

ISO 11137-2:2012

ISO 11137-2:2006

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