标准摘要
[中文适用范围]： 本文件规定了医疗器械或用于医疗器械的材料的局部效应，在植入前的临床前评估中所采用的植入试验方法的要求。本文件适用于评估在必要时需要穿透皮肤或粘膜组织的医疗器械引起的局部组织反应。本文件适用于需要进行植入评估的医疗器械或材料，其形态可为固体或非金属体（如多孔材料、液体、凝胶、膏剂、粉末及颗粒），可为可吸收、可降解或不可吸收，亦可为组织工程医疗产品（TEMPs）。此类植入试验旨在评估局部生物反应，不用于评价或确定试验样品在机械载荷或功能性能方面的表现。此外，本文件未提供关于满足全身毒性、致癌性、致畸性或致突变性要求的试验方法和研究设计方案。然而，研究方案可进行修改，以评估其他生物学效应。 [外文原描述]： This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This document is applicable to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required. This document is applicable to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, non- absorbable, or can be tissue-engineered medical products (TEMPs). These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biological effects.
英文名称Biological evaluation of medical devices — Part 6: Tests for local effects after implantation