Reference number
ISO 11138-7:2019
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
Read sample
ISO 11138-7:2019
74113
Published (Edition 1, 2019)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.

ISO 11138-7:2019

ISO 11138-7:2019
74113
Language
Format
CHF 194
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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

  •  : Published
     : 2019-03
    : International Standard confirmed [90.93]
  •  : 1
     : 64
  • ISO/TC 198
    11.080.01 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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