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ÖNORM EN ISO 11737-3

Issue date: 2026 02 01

Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023)

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. This document does not address setting specific endotoxin limit specifications.

General information on ÖNORM EN ISO 11737-3

Format
Paper | 77 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

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