Standards Development

Scope

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.

The results of this SBF test (see Clause 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.

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.