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ISO 11138-1

Sterilization of health care products - Biological indicators - Part 1: General requirements

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Organization: ISO
Publication Date: 1 March 2017
Status: active
Page Count: 48
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

This document 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.

This document 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.

This document 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.

Document History

ISO 11138-1
March 1, 2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their...
July 1, 2006
Sterilization of health care products Biological indicators Part 1: General requirements
General This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and...
January 1, 1994
Sterilization of Health Care Products - Biological Indicators - Part 1: General First Edition
This part of ISO 11138 specifies general production, labelling and performance requirements for the manufacture of biological indicators and suspensions intended for use in the validation and...

References

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