Reference number
ISO 11138-7:2019
© ISO 2025
International Standard
ISO 11138-7:2019
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
Edition 1
2019-03
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Published (Edition 1, 2019)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.

ISO 11138-7:2019

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CHF 199
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Abstract

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.

It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.

It is not applicable to liquid immersion sterilization processes.

General information

  • Status
     : Published
    Publication date
     : 2019-03
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 1
    Number of pages
     : 64
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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