Bacterial endotoxins— Test methods, routine monitoring, and alternatives to batch testing
|Publication Date:||1 January 2019|
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.