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ISO/WD TS 25887

Sterilization of health care products — Microbiological methods — Bacterial endotoxin testing — Use of recombinant animal-free reagents

Опште информације

20.20     13. 10. 2026.

ISO

ISO/TC 198

Tehnička specifikacija

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 recombinant animal-free reagents.

This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies described in ISO 11737-3:2023 are not included.

This document does not address setting specific endotoxin limit specifications.

Životni ciklus

TRENUTNO

PROJEKAT
ISO/WD TS 25887
20.20 Početak rada na prednacrtu standarda
13. 10. 2026.