标准摘要
[中文适用范围]： 1.1 包含 本文件规定了使用细菌内毒素检测 (BET) 方法和变形细胞裂解物试剂测定医疗保健产品、成分或原材料表面或内部细菌内毒素的通用标准。1.2 排除 1.2.1 本文件不适用于评估除细菌内毒素以外的热原。不包括其他内毒素检测方法（见 B.12）。1.2.2 本文件不涉及制定具体的内毒素限度规范。 [外文原描述]： 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.
英文名称Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing