AAMI 11138-4

Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes

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Organization: AAMI
Publication Date: 1 January 2017
Status: active
Page Count: 21
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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.

NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.

NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Document History

AAMI 11138-4
January 1, 2017
Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry 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 4: Biological indicators for dry 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...
January 1, 2006
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
A description is not available for this item.

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