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ANSI/AAMI ST72:2011 (ANSI/AAMI ST 72:2011)

Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing

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


Content Provider
Association for the Advancement of Medical Instrumentation [aami]


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Document History
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