Details tests to identify the presence of pyrogenic materials in or on a medical device. Defines measurement of the rise in body temperature of rabbits during a period of 3 h after an intravenous injection of an extract of the device made with pyrogen-free saline. Recommended for the initial assessment of devices for long-term implantation within the body tissue, grafts and hip prostheses, for long-term or repeated contact with mucosal surfaces, contraceptive devices, for short term use within the body or in contact with mucosal surfaces, tracheal tubes, catheters and intravenous cannulae, to administer substances that are introduced parenterally into the body, haemodialysis equipment, intravenous sets and syringes.

BS EN ISO 10993-11 : 2009