Implantation Effects Test

The ISO 10993-6 standard published by the International Standards Organization (ISO) describes test methods for the evaluation of local effects after implantation of biomaterials intended for use in medical devices. The full name of this standard is: ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.

This standard applies to the following materials:

• Solid and non-absorbable materials
• Non-solid materials such as porous materials, liquids, gels, pastes and particulates
• Solid or non-solid degradable or absorbable materials

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 may have been compromised to assess local tissue responses.

During testing, the sample is implanted in a suitable site and animal species for evaluation of the biological safety of the material. Local effects are evaluated by comparing the tissue response with the outcome of control materials used in medical devices for which clinical acceptability and biocompatibility have been established.

The purpose of the test methods described 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. Particularly for degradable/absorbable materials, the degradation properties of the material and the resulting tissue response should be determined.

This 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. Systemic toxicity studies conducted by implantation may meet the requirements of this standard. When conducting combined studies to assess local effects and systemic effects, the requirements of both standards should be met.

For the purposes of this standard,

• Absorption refers to the action of a foreign material or degradation products that pass through or are assimilated by cells or tissues over time.
• Distortion refers to the breakdown of a material.
• Decomposition product refers to any intermediate or final by-product resulting from the physical, metabolic or chemical decomposition of a material.

Our organization also provides implantation effects testing 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.