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ISO 11737-3:2023

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

General information

Valid from 26.06.2023
Directives or regulations
None

Standard history

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Date
Type
Name
26.06.2023
Main
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.

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