naSRPS EN ISO 11737-3:2025

Sterilizacija proizvoda za zdravstvenu zaštitu - Mikrobiološke metode - Deo 3: Testiranje bakterijskih endotoksina

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

Apstrakt

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.

Povezane direktive

NAPOMENA: Ukoliko se u polju sa nazivom direktive ne nalazi reč „harmonizovan“ (obeležena zelenom bojom), to znači da evropski standard nije citiran u OJEU.