ISO 10993-6:2007 医疗设备的生物评价 第6部分：移植后的局部影响试验

标准编号：ISO 10993-6:2007

中文名称：医疗设备的生物评价 第6部分：移植后的局部影响试验

英文名称：Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

发布日期：2007-04

标准范围

ISO 10993-6:20 07规定了用于医疗器械的生物材料植入后局部效应评估的试验方法。ISO 10993-6:20 07适用于以下材料:固体且不可生物降解；可降解和/或可再吸收；非固体，如多孔材料、液体、糊状物和颗粒。ISO 10993-6:20 07也可应用于预期在表面或衬里可能已被破坏的临床适应症中局部使用的医疗器械，以评估局部组织反应。ISO 10993的这一部分不涉及全身毒性、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见解。通过植入进行的全身毒性研究可满足ISO 10993-6:20 07的要求。

ISO 10993-6:2007 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.ISO 10993-6:2007 applies to materials that are:

1. solid and non-biodegradable;
2. degradable and/or resorbable;
3. non-solid, such as porous materials, liquids, pastes and particulates.

ISO 10993-6:2007 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses.This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of ISO 10993-6:2007.

标准预览图