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ISO 11737-3:2023

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

Publication date:   Jun 26, 2023

General information

60.60 Standard published   Jun 26, 2023

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general | 07.100.10   Medical microbiology

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Scope

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.

Life cycle

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PUBLISHED
ISO 11737-3:2023
60.60 Standard published
Jun 26, 2023