Biocompatibility phase 2 tests

The testing program for any medical device can be divided into five phases (1) biocompatibility, (2) short-term bench (or in vitro) tests, (3) long-term bench tests, (4) animal (or in vivo) studies, and (5) human clinical studies. For each of these five phases, the type of device and length of time it will be used must be considered in developing test protocols. 

The biocompatibility testing protocol will depend on the category of device and duration of contact as described above. For chronically implantable materials, the entire range of ISO 10993-1 is recommended, as is summarized below. Please note that ISO 10993-1 is in the process of revision. It is recommended that the reader consult the revised version when it is available. Because of cost constraints, a stepwise evaluation is recommended. The decision to conduct the more costly phase 2 tests would depend on the results of the phase 1 tests. Again, the materials must be processed, cleaned, sterilized, and packaged in the same manner as the final product. Note that the following tests are listed and briefly described in ISO 10993-1, but detailed protocols are provided in other parts of the standard for most of these (ISO 10993-2 through 12). 

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