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ISO 11737-3:2023 PDF
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Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
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.
| Edition | 2023 |
|---|---|
| Standard Part No | 3 |
| Published Date | 2023 |
| Published By | International Standardization Organisation |
| Page Count | 62 |
