Naturvetenskap och tillämpad vetenskap

This document describes a highly specific method for the enumeration of Escherichia coli (E. coli) in water. The method is based on membrane filtration, subsequent culture at 44 °C on a chromogenic agar medium containing a chromogenic ingredient for the detection of the enzyme ß-glucuronidase, and calculation of the number of target organisms in the sample. Because of the high specificity of the method, this document is suitable for waters with high levels of background bacteria, such as surface waters including bathing water and wastewater. E. coli strains which do not grow at 44 °C and those that are β-glucuronidase negative, such as E. coli O157, will not be detected as E. coli by this method.

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. This document does not address setting specific endotoxin limit specifications.