Medical Device Pyrogenicity Tests Services

At present, more and more medical devices are used in clinical practice, and such products must be tested for pyrogen before they are put on the market. There are two common methods for pyrogen testing of medical devices, namely the rabbit pyrogen method and the bacterial endotoxin method.

The international standard ISO10993-11:2009 gives the types of substances that can cause pyrogenic reactions. Pyrogenic reactions (also known as pyrogenic reactions) may be mediated by materials, endotoxins or other substances. Among them, endotoxin-mediated pyrogenicity originates from bacterial endotoxins of Gram-negative bacteria, which is usually caused by contamination by bacteria or their metabolites during the production process of medical devices. Material-mediated pyrogenicity is caused by non-endotoxin-related factors. Currently, it is known that non-endotoxin substances that produce pyrogenic reactions include endogenous pyrogens (such as IL-1, IL-6, TNFα, TNFβ), prostaglandins, inducers (such as polyadenylic acid, polyuridylic acid, etc.), substances that interfere with the body temperature regulation center (such as LSD, cocaine, morphine), oxidative phosphorylation uncouplers, bacterial exotoxins (such as TSST-1, SEA, Spe F, Spe C), neurotransmitters (such as norepinephrine, serotonin), certain metals (such as nickel salts), etc. Researchers should choose the method of pyrogen testing based on the type of potential pyrogen.