naSRPS EN ISO 11737-3:2025

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

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

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.