This practice is a guideline for a short-term screening test for the evaluation of the tissue response to materials that may be selected for implantation in the human body. This test may be performed prior to longterm testing (for example, Practice F 981) to eliminate unsuitable candidate materials early and to save further animal testing.

This practice may be used to detect toxic effects of materials in general (see Appendix X1). However, it is particularly suitable for the testing of materials that are intended to have contact with subcutaneous tissues or soft tissues in general. For materials intended to be inserted specifically into muscle tissues, Practice F 763 should be considered as a short term test method.

The suggested implant specimens are cylindrical. A special grooved type of cylinder may be used (see Fig. X2.1 of Appendix X2) to allow tissue interlocking that could keep the implant in place and minimize tissue irritation through motion at the interface that otherwise could contribute to increased variance of the results. In case ungrooved cylinders are used (see Fig. X1.2 of Appendix X2), probable motion at the implant/tissue interface must be taken into account. Control cylinders should be shaped like the test cylinders.

The type of surface preparation of the specimens can affect the tissue reaction, therefore the preparation procedure should be noted in the report. The test may be used to compare the effect of different surface structures or conditions of the same material or to assess the effect of various treatments of modifications of a material.