A technical brief by Steven Richter, Ph.D, Accuratus Lab Services
Endotoxin testing is required for medical devices that come in contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid. These devices include intravenous catheters, vascular grafts, and dialysis tubing and accessories. With a variety of testing methods available, it’s important medical device manufacturers understand bacterial endotoxin characteristics, the methods used for testing, and the steps necessary to ensure product sterility and compliance.
This new technical brief from Accuratus Lab Services reviews the fundamentals of Endotoxin testing and provides an overview of the different testing methods available. The brief also discusses the different testing devices, batch size requirements, and preparation of those devices for testing.