Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) onmedical devices, components, or raw materials. Bacterial endotoxin methodologies coveredinclude both qualitative (limit) methods and quantitative (end-point) methods using Limulusamebocyte lysate methodology. Determination of pyrogens other than bacterial endotoxins is notcovered and acceptable levels for bacterial endotoxins are not covered.
Original price was: $99.00.$49.00Current price is: $49.00.
Bacterial endotoxins – Test methodologies, routine monitoring, and alternatives to batch testing
Association for the Advancement of Medical Instrumentation , 09/01/2002
Pages: 34
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