International Standard
ISO 11137-2:2013
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Reference number
ISO 11137-2:2013
Edition 3
2013-06
© ISO 2024
International Standard
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Published (Edition 3, 2013)
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
This standard has 1 amendment.

ISO 11137-2:2013

Format
Language
CHF 194
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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.

General information

  • Status
     : Published
    Publication date
     : 2013-06
    Stage
    : Close of review [90.60]
  • Edition
     : 3
    Number of pages
     : 68
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2022

Format
Language
CHF 18
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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