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AAMI - ST72

Bacterial endotoxins—Test methodologies, routine monitoring, and alternatives to batch testing

inactive
Organization: AAMI
Publication Date: 1 January 2002
Status: inactive
Page Count: 35
scope:

This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methodology.

NOTE-Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.

The bacterial endotoxin test methodologies covered in this document include both qualitative methods and quantitative methods.

This document is not applicable to the determination of pyrogens other than bacterial endotoxins.

This document does not specify acceptable levels for bacterial endotoxins.

NOTE-For acceptable levels for bacterial endotoxins, reference the appropriate regulatory standards.

Document History

January 1, 2019
Bacterial endotoxins— Test methods, routine monitoring, and alternatives to batch testing
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET)...
January 1, 2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET)...
January 1, 2011
Bacterial endotoxins — Test methods, routine monitoring, and alternatives to batch testing
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methods....
January 1, 2011
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methods....
ST72
January 1, 2002
Bacterial endotoxins—Test methodologies, routine monitoring, and alternatives to batch testing
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methodology....
January 1, 2002
Bacterial Endotoxin - Test Methodologies, Routine Monitoring and Alternatives to Batch Testing
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methodology....

References

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