Implantation tests are performed to evaluate the local pathological effects on living tissue of a material or final product sample that is surgically implanted or placed in an implant site or tissue suitable for the intended application of the biomaterial or medical device. This assessment is carried out both roughly and at the microscopic level.
In other words, implantation tests are performed to evaluate local pathological effects on living tissue at both the macroscopic and microscopic level of an implant.
The main standard applied when performing implantation tests is the following standard published by the International Standards Organization (ISO): ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation. This standard describes test methods for the assessment of local effects after implantation of biomaterials intended for use in medical devices. The materials covered by this standard are:
While testing, the sample is implanted in a suitable site and animal species for evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test specimen in terms of mechanical or functional loading. The ISO 10993-6 standard also applies to medical devices intended for topical use in clinical indications where the surface or coating has been compromised to assess local tissue responses.
During assessment, local effects are compared to tissue response caused by a test sample with tissue caused by control materials used in medical devices for which clinical acceptability and biocompatibility have been established.
The purpose of these tests is to characterize the history and evolution of tissue response after implantation of a medical device or biomaterial, including eventual integration or absorption/degradation of the material. Especially for degradable or absorbable materials, the degradation properties of the material and the resulting tissue response are determined.
The ISO 10993-6 standard does not deal with systemic toxicity, carcinogenicity or mutagenicity. However, long-term implantation studies to assess local biological effects provide insight into some of these properties.
Our organization also provides implantation test services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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