这两本书包括1997年版的《医疗器械生物学评价》（BIOT7）和1998年版的《医疗器械生物学评价》（BIOT8）。生物评价系列中的13项现行最终标准的总和，以及所有13项标准的指数，包括在1998年的补充文件中。（第7部分还包括第1部分的替代版本，其修订版见1998年补充文件。虽然第1部分的第一版现已被替代，但FDA根据其认可计划认可的正是该版本，因此可能仍有兴趣。）

This two-book set consists of Biological Evaluation of Medical Devices, 1997 edition (BIOT7) and Biological Evaluation of Medical Devices, 1998 supplement (BIOT8). Combined total of 13 current final standards in the biological evaluation series, with index of all 13 standards included in the 1998 supplement. (BIOT7 also includes a superseded edition of Part 1, the revision of which appears in the 1998 supplement. While the first edition of Part 1 is now superseded, it is this edition that is recognized by the FDA under its Recognition Program, therefore may still be of interest.)