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

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

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1   Scope

1.1   Inclusions

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.