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ISO 11737-3:2023

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 11737-3:2023
Document Year: 2023
Pages: 62
Edition: 1
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products

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ISO 11737-3:2023
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