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Complement activation is a component of the innate immune system that helps eliminate microorganisms and damaged cells by attacking the cells plasma membrane. The compliment system is comprised of many small proteins and many of them can be used as markers for complement activation but measurements of C3a, C5a, TCC, Bb, iC3b, C4d, SC5b-9, CH50, C3 convertase, and C5 convertase are suggested by ISO 10993-4.

Activation of the complement system by a medical device or other foreign material can have deleterious effects including tissue damage and inflammation. ISO 10993-4 recommends that the following devices be tested for complement activation: Extracorporeal membrane oxygenator system, hemodialysis/hemofiltration equipment, percutaneous circulatory support devices, devices for absorption of specific substances from blood, donor and therapeutic apheresis equipment, and intra-aortic balloon pumps.

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