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

The purpose of this document is to consolidate the requirements and guidance for testing for bacterial endotoxins. This includes product required to be non-pyrogenic due to intended use and non-pyrogenic labelling. Details are also provided on selection of product units, method suitability, use of techniques for routine testing, interpretation of test results, and alternatives to batch testing and risk assessment.