AAMI - ST72
Bacterial endotoxins—Test methodologies, routine monitoring, and alternatives to batch testing
Organization: | AAMI |
Publication Date: | 1 January 2002 |
Status: | inactive |
Page Count: | 35 |
scope:
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methodology.
NOTE-Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.
The bacterial endotoxin test methodologies covered in this document include both qualitative methods and quantitative methods.
This document is not applicable to the determination of pyrogens other than bacterial endotoxins.
This document does not specify acceptable levels for bacterial endotoxins.
NOTE-For acceptable levels for bacterial endotoxins, reference the appropriate regulatory standards.