Bacterial endotoxin testing by ISO 11737-3

The ISO 11737-3 standard provides internationally recognized guidelines for bacterial endotoxin testing of medical devices. Tests described in the standard can be used to evaluate the pyrogenic potential of medical devices for batch release and to validate manufacturing, cleaning, and sterilization processes in terms of their capacity to prevent endotoxin contamination.

The Limulus Amebocyte Lysate (LAL) test is the most common approach to endotoxin testing. ISO 11737-3 describes several LAL methods, including kinetic turbidimetric and chromogenic techniques.

One routine LAL assay for one sample with a chromogenic method is included in the displayed example price.

We can also offer custom bacterial endotoxin test packages, especially for large sample volumes. Please describe your testing needs using the form below to get a quote for your samples.