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Glavni meni

ISO 11737-3:2023

Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
26. 6. 2023.

Опште информације

60.60     26. 6. 2023.

ISO

ISO/TC 198

Međunarodni standard

11.080.01     07.100.10  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

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 (see B.12). This document does not address setting specific endotoxin limit specifications.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 11737-3:2023
60.60 Standard objavljen
26. 6. 2023.