60.60 Standard published Jun 26, 2023
ISO
ISO/TC 198 Sterilization of health care products
International Standard
11.080.01 Sterilization and disinfection in general | 07.100.10 Medical microbiology
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.
PUBLISHED
ISO 11737-3:2023
60.60
Standard published
Jun 26, 2023