Activation of the complement system by a medical device or other foreign material can have deleterious effects including tissue damage and inflammation. The ISO 10993-4:2017 standard describes the biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. This standard recommends that the following medical devices be tested specifically for complement activation:
- Extracorporeal membrane oxygenator system.
- Hemodialysis/hemofiltration equipment.
- Percutaneous circulatory support devices.
- Devices for absorption of specific substances from blood, donors and therapeutic apheresis equipment.
- Intra-aortic balloon pumps.
Haemocompatibility testing is essential for assessing the interactions of medical devices in contact with blood. ISO 10993-4:2017 provides general requirements for the evaluation of medical device interactions with blood under five categories of testing (Thrombosis, Coagulation, Platelets, Hematology and Complement System). It describes:
- A classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1.
- The fundamental principles governing the evaluation of the interaction of devices with blood.
- The rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
The only test recommended to be performed is the incubation of the test article and predicate directly in human serum (or whole blood) and the measurement of the complement protein SC5b-9, using commercially ELISA kits. Analysis of variance (ANOVA) is used to compare the test article and predicate devices to determine if there are statistically significant differences in the mean populations.
Medistri’s in-house laboratory possesses an in-depth comprehension of the Complement Activation process to meet your regulatory requirements.