Bacterial Endotoxin Test (BET) / LAL Test Method
The BET Test is used to detect bacterial endotoxins on medical devices. Found in the outer cell wall of gram-negative bacteria, endotoxins account for an estimated 99% of pyrogens found on the surfaces of medical devices. The most common method used for detecting endotoxin is the Limulus Amebocyte Lysate
(LAL) test method.
Why you need it...
While there are no specific ISO standards regulating endotoxin presence, both American and European regulatory authorities require that
samples from each manufacturing batch of sterile medical devices intended for contact with human blood or cerebrospinal fluid during
their routine use be tested for the presence of endotoxin.
SteriPro® Laboratories provides:
SteriPro® Certified Experts
- The Kinetic-Chromogenic Assay (North America and Europe)
- The Kinetic-Turbidimetric Assay (Germany)
- The Gel-Clot Method (Germany and China)