International Standard
ISO 11737-3:2023
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
Reference number
ISO 11737-3:2023
ISO 11737-3:2023
Edition 1
2023-06
2023-06
© ISO 2024
International Standard
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.
General information
-
Status: PublishedPublication date: 2023-06Stage: International Standard published [60.60]
-
Edition: 1Number of pages: 62
-
Technical Committee :ISO/TC 198
- RSS updates
Life cycle
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)