PRODUCTION OF A PERICARDIAL PRIMARY REFERENCE MATERIAL

描述（改编自申请人摘要）：组织生物材料是 用于各种医疗装置，包括心脏瓣膜、血管 移植物、外科补片和支撑物以及各种皮肤替代物。 这 第一阶段的研究提出了生产和表征的方法 使用牛心包作为一级参比物质（PRM） 起始材料 该计划涉及小批量生产 心包PRM，然后对体积进行初步表征 和表面性质，以评估使用心包作为 组织PRM。 这项工作将导致第一个组织生物材料， 在临床环境之外可商购获得。 心包PRM 将商业化作为校准理化 和生物测试。 PRM的制造将提供 良好表征的、稳定的、基于组织的材料到生物材料 研究人员和医疗器械开发人员。

DESCRIPTION (Adapted from applicant's abstract): Tissue biomaterials are used in a variety of medical devices including cardiac valves, vascular grafts, surgical patches and supports and various skin substitutes. This Phase I research proposes methods for the production and characterization of a primary reference material (PRM) using bovine pericardium as a starting material. The program involves the production of small batches of pericardial PRM followed by preliminary characterization of the bulk and surface properties to assess the feasibility of using pericardium as a tissue PRM. This work will result in the first tissue biomaterial to be commercially available outside the clinical setting. The pericardial PRM will be commercialized as a standard for calibration of physicochemical and biological tests. The fabrication of PRM will provide a source of well characterized, stable, tissue-based material to biomaterials investigators and medical device developers.