BS ISO 11737-3:2023
保健品滅菌微生物學方法細菌內毒素檢測

Sterilization of health care products. Microbiological methods. Bacterial endotoxin testing

適用范圍: 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 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.

術語	描述
細菌內毒素測試 bacterial endotoxins test (BET)	通過將水樣測試樣本或測試樣本提取物與鱟試劑（TAL或LAL）結合，并通過視覺、濁度或顯色技術測量相應的比例反應來測量細菌內毒素的測定。
批次 batch	在特定制造周期中生產的，意圖或聲稱在特性和質量上一致的產品數量。
顯色技術 chromogenic technique	一種細菌內毒素測試（BET）方法，基于鱟試劑（LAL）與內毒素相互作用產生的顏色反應來量化內毒素。
控制標準內毒素 control standard endotoxin (CSE)	內毒素標準制劑，其效力已針對特定批次的鱟試劑（LAL）相對于參考標準內毒素（RSE）進行了標準化。
去熱原 depyrogenation	用于去除或滅活熱原物質至指定水平的過程。