International Standard
ISO 11138-1:2017
Sterilization of health care products — Biological indicators — Part 1: General requirements
Reference number
ISO 11138-1:2017
Edition 3
2017-03
International Standard
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ISO 11138-1:2017
66442
Published (Edition 3, 2017)
This standard was last reviewed and confirmed in 2022. Therefore this version remains current.

ISO 11138-1:2017

ISO 11138-1:2017
66442
Format
Language
CHF 173
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Abstract



ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.

NOTE National or regional regulations can apply.

ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.

General information

  •  : Published
     : 2017-03
     : 2018-02
    : International Standard confirmed [90.93]
  •  : 3
     : 41
  • ISO/TC 198
    11.080.01 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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