Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

2Scope / Description

This part of ISO 10993 specifies test methods for assessing local effects following the implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are solid and non-resorbable, non-solid (such as porous materials, liquids, gels, pastes, and suspended particles), and biodegradable and/or resorbable. The test specimen is implanted at a site and in an animal species suitable for assessing the biosafety of the material. These implantation tests are not intended to determine the performance of the test specimen in terms of mechanical or functional durability. This part of ISO 10993 can also be applied to medical devices intended for local application, where a body cavity has been opened to assess the responses of the local tissue. The local effects are assessed by comparing the tissue response elicited by a test specimen with the tissue response elicited by control materials. This section does not cover systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity.