ISO 11737-3:2023
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ISO 11737-3:2023

Sterilization of health care products — Microbiological methods
Part 3: Bacterial endotoxin testing

Summary

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.

Notes

60.60 : Norme internationale publiée

Technical characteristics

Publisher International Organization for Standardization (ISO)
Publication Date 06/26/2023
Edition 1
Page Count 62
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ISBN ---
Weight (in grams) ---
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