Biological evaluation of medical devices containing nanomaterials: bacterial endotoxin test

This Standard specifies the application of the Limulus test evaluation of nanomaterials, for in vitro biological assay system cells. This Standard applies to be an aqueous medium (for example: water, serum or reaction medium) or extracts dispersed nanomaterials, making nanomaterials with such culture medium at an appropriate time 37��C. This Standard is limited to in vitro test sample, the method can also be applied to animal by the parenteral route of administration of nanomaterials.