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ISO 11138-3

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

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Organization: ISO
Publication Date: 1 March 2017
Status: active
Page Count: 16
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.

NOTE 2 National or regional regulations can provide requirements for work place safety.

Document History

ISO 11138-3
March 1, 2017
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization...
ISO 11138-3
July 1, 2006
Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes
This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of...
ISO 11138-3
September 15, 1995
Sterilization of Health Care Products - Biological Indicators - Part 3: Biological Indicators for Moist Heat Sterilization
A description is not available for this item.
11138-3
January 1, 1995
Sterilization of Health Care Products - Biological Indicators - Part 3: Biological Indicators for Moist Heat Sterilization First Edition
A description is not available for this item.

References

This document references:
ISO 18472 - Sterilization of health care products - Biological and chemical indicators - Test equipment
Published by ISO on August 1, 2018
This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the...
This document references:
ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
Published by ISO on March 1, 2017
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their...
This document references:
ISO 17665-1 - Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on August 15, 2006
Inclusions This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this...
This document references:
ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
Published by ISO on March 1, 2017
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their...
This document references:
ISO 17665-1 - Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on August 15, 2006
Inclusions This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this...
This document references:
ISO 18472 - Sterilization of health care products - Biological and chemical indicators - Test equipment
Published by ISO on August 1, 2018
This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the...
This document is referenced by:
CSA Z10651-5 - Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
Published by CSA on January 1, 2008
This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators (3.10) intended for use with humans by first responders. This...
This document is referenced by:
AAMI TIR17665-3 - Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization
Published by AAMI on January 1, 2014
This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and...
This document is referenced by:
BS EN ISO 16061 - Instruments for use in association with non-active surgical implants — General requirements
Published by BSI on April 30, 2021
A description is not available for this item.
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