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AAMI ST72

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

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Organization: AAMI
Publication Date: 1 January 2019
Status: active
Page Count: 65
scope:

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) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus.

NOTE Although the scope of this standard is limited to medical devices, it also includes requirements and provides testing guidance that might be applicable to other health care products, such as, biologics, tissue-based products and combination products.

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

Document History

AAMI ST72
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....
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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