Biocompatibility hemocompatibility testing

The international standard organization ISO 10993 standard plays an important role in the assessment of the biocompatibility of a medical device. In principle, a great number of tests have to be undertaken depending on the intended use of the medical device. The standard describes tests on toxicity, carcinogenicity, and hemocompatibility, among others. Some of these tests are simple in vitro tests, while others require extensive animal experiments. For implanted medical devices,... 

Biocompatibility determines the interface reactions of blood and tissue cells with the surface of the biomaterial. In this context, the term hemocompatibility mainly refers to blood component reactions during contact with the biomaterial [202]. It is of great importance to test various polymer characteristics in detail before developing the elaborated design for in vivo application. Over the past years, a variety of methods have been established to determine hemo- and biocompatibility of polymer implants. In this chapter a summary of standardized and new methods is provided. 

P4HB and P3HB-4HB have been evaluated in preclinical tests reconunended by the FDA for medical devices. These tests include cytotoxicity, sensitization, irritation and intracutaneous reactivity, hemocompatibility, and implantation. Thus for example, P4HB films and sutures were subjected to a complete series of biocompatibility test protocols that were performed in accordance with the FDA s GLP regulations as set forth in 21 CFR, part 58, as well as ISO 10993-1. The test results confirmed that P4HB is nontoxic and biocompatible (Martin DP, personal communication). 

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