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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 (BIOT7 also includes a superseded edition of Part 1, the revision of which appears in the 1998 supplement. While the first edition of Part 1 is now superseded, it is this edition that is recognized by the FDA under its Recognition Program, therefore may still be of interest.)

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