Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing (ISO 11737-3:2023); German and English version prEN ISO 11737-3:2025
Abstract
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.
Begin
2025-10-27
WI
00204097
Planned document number
DIN EN ISO 11737-3
Project number
17600202
Responsible national committee
NA 176-03-09 AA - Sterilization and processing of medical devices
Responsible european committee
CEN/TC 204/WG 12 - Annex Z reviews
