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NF ISO 11737-3, S98-118-3 (07/2023)
Stérilisation des produits de santé - Méthodes microbiologiques - Partie 3 : essai des endotoxines bactériennes
Automatic translation from French :
Sterilization of health products - Microbiological methods - Part 3: testing for bacterial endotoxins
Automatic translation from French :
Sterilization of health products - Microbiological methods - Part 3: testing for bacterial endotoxins
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Summary
This document specifies the general criteria to be applied for the determination of bacterial endotoxins present on or in health products, components or raw materials using the bacterial endotoxin (BEE) test methods, using the reagents of amebocyte lysate. This document does not apply to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address the establishment of specific endotoxin limit specifications.
(Automatic translation from French)
(Automatic translation from French)
Technical characteristics
| Publisher | Association Française de Normalisation (AFNOR) |
| Publication Date | 07/01/2023 |
| Release Date | 07/01/2023 |
| Page Count | 75 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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