Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

2Scope / Description

This part of 1S0 10993 specifies test methods for evaluating local effects after implantation of biomaterials/medical devices. Applicable to solid and non-absorbable materials, including porous materials, liquids, gels, pastes and granules. Also applicable to degradable and/or resorbable materials, which may be solid or non-solid. These implantation tests are not intended to evaluate the performance of the test specimens with respect to mechanical or functional loads. This part may also be intended for use in clinical applications where surface or lining breakdown is required to evaluate local tissue responses. Local effects are evaluated by comparing the test specimens to control materials with established clinical acceptability and biocompatibility properties. The goal of the test method is to characterize the history and evolution of tissue responses after implantation of a medical device/biomaterial, including final integration, absorption/degradation of the material. Particularly for degradable/resorbable materials, the degradation characteristics of the material and the tissue responses it evokes need to be determined. This part does not address systemic toxicity, carcinogenicity, teratogenicity and mutagenicity studies.