Reference number
ISO 11137-2:2013
International Standard
ISO 11137-2:2013
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Edition 3
2013-06
Read sample
ISO 11137-2:2013
62442
Published (Edition 3, 2013)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.
This standard has 1 amendment.

ISO 11137-2:2013

ISO 11137-2:2013
62442
Language
Format
CHF 194
Convert Swiss francs (CHF) to your currency

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

  •  : Published
     : 2013-06
    : International Standard to be revised [90.92]
  •  : 3
     : 68
  • ISO/TC 198
    11.080.01 
  • RSS updates

 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

ISO 11137-2:2013/Amd 1:2022
81755
Language
Format
CHF 18
Convert Swiss francs (CHF) to your currency

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

Got a question?

Check out our Help and Support