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ISO 11737-3:2023

Current Revision

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

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 11737
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 198
Publish Date Document Id Type View
Not Available ISO 11737-3:2023 Revision