本文件规定了使用细菌内毒素试验（BET）方法和鲎试剂测定保健品、成分或原材料上或其中细菌内毒素的一般标准。本文件不适用于细菌内毒素以外的热原的评估。不包括其他内毒素检测方法（见B.12）。本文件不涉及设置特定的内毒素限量规范。

This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.