标准编号:ISO 11737-3:2023

中文名称:医疗保健产品的灭菌 微生物学方法 第3部分:细菌内毒素检验

英文名称:Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing

发布日期:2023-06

标准范围

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.

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