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 recombinant animal-free reagents.
This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies described in ISO 11737-3:2023 are not included.
This document does not address setting specific endotoxin limit specifications.
Registration number (WIID)
91839
Scope
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 recombinant animal-free reagents.
This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies described in ISO 11737-3:2023 are not included.
This document does not address setting specific endotoxin limit specifications.
