Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

1. Scope 1.1 This guide is intended to assist the biomaterials testing laboratory in the conduct and evaluation of tumorigenicity tests to evaluate the potential for new materials to evoke a neoplastic response. The procedure is generally reserved only for those materials which have not previously been used for human implantation for a significant period of time.