外科植入物 材料 模拟体液（SBF）制备程序及检测方法 用于初步筛选与骨接触的植入材料在SBF中形成类骨质的能力

[中文适用范围]： 本文件规定了制备模拟体液（SBF）的程序，以及作为评估与骨接触的植入材料表面形成磷灰石能力的初步筛选工具的测试方法。注1：仅凭本SBF测试（见第7章）的结果，不能确定材料与骨的结合能力。该测试可与其他体外和体内确认性测试结合使用，以确定植入材料在体内与骨组织结合的能力。本文件仅限于评估用于骨接触植入的块状固体材料的体外磷灰石形成能力，并不用于评估多孔材料、颗粒材料、溶质分子或离子的这种能力。注2：由于多孔材料具有较大的表面积，需要大量SBF，且SBF通常难以渗透进入其多孔结构，因此多孔材料被排除在测试样品之外。此外，按照本文件描述的方法，难以分析多孔材料的内表面。 [外文原描述]： This document specifies a procedure for preparing the simulated body fluid (SBF) and a test method for use as an initial screening tool in the evaluation of apatite formation on the surfaces of bone-contacting implant materials. NOTE 1 The results of this SBF test (see Clau se 7 ) alone do not establish bone-bonding ability. The test can be used along with other in vitro and in vivo confirmatory tests to establish an implant material’s ability to bond with bone tissue in vivo. This document is limited to an assessment of the in vitro apatite-forming ability of bulky solid materials used for bone-contacting implants and is not intended to be used to evaluate this ability of porous materials, particulate materials or solute molecules or ions. NOTE 2 Porous materials are excluded from test specimens because they require a large volume of SBF due to high surface area, and often have difficulty in penetration of SBF into their porous bodies. Furthermore, analysis of the inner surfaces of porous materials is difficult by the method described in this document.