ISO 11737:2023
ISO 11737:2023 Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing
CDN $379.00
Description
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
1
Published Date
2023-06-26
Status
PUBLISHED
Pages
62
Language
English
Format
Secure PDF
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Abstract
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.
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