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AAMI - 11138-3

Sterilization of health care products—Biological indicators—art 3: Biological indicators for moist heat sterilization processes

inactive
Organization: AAMI
Publication Date: 1 January 2006
Status: inactive
Page Count: 22
scope:

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 sterilization processes employing moist heat as the sterilizing agent.

Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While airsteam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

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

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

Document History

January 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...
January 1, 2006
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
A description is not available for this item.
11138-3
January 1, 2006
Sterilization of health care products—Biological indicators—art 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...

References

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