ISO 10993-6:2016规定了医疗器械用生物材料植入后局部效应评估的试验方法。 ISO 10993-6:2016适用于以下材料: -固体且不可吸收， -非固体，如多孔材料、液体、凝胶、糊状物和颗粒，以及 -可降解和/或可吸收，可为固体或非固体。 将试样植入适合于评估材料生物安全性的部位和动物物种中。这些植入试验的目的不是评估或确定试样在机械或功能负载方面的性能。 ISO 10993的这一部分也适用于局部使用的医疗器械，这些医疗器械的表面或衬里可能已被破坏，以评估局部组织反应。 通过比较试验样品引起的组织反应与医疗器械中使用的对照材料引起的组织反应，评估局部效应，这些医疗器械的临床可接受性和生物相容性特征已经确定。试验方法的目的是描述医疗器械/生物材料植入后组织反应的历史和演变，包括材料的最终整合或吸收/降解。 尤其是对于可降解/可吸收材料，应确定材料的降解特性以及由此产生的组织响应。 ISO 10993-6:2016不涉及系统毒性、致癌性、致畸性或致突变性。然而，旨在评估局部生物效应的长期植入研究可能会提供对其中一些特性的洞察。通过植入进行的全身毒性研究可能满足ISO 10993本部分的要求。在进行评估局部效应和系统效应的联合研究时，应满足这两个标准的要求。

ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. ISO 10993-6:2016 applies to materials that are - solid and non-absorbable, - non-solid, such as porous materials, liquids, gels, pastes, and particulates, and - degradable and/or absorbable, which may be solid or non-solid. The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses. The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined. ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.