1.1This guide describes some of the more common methods that are available for measuring the topographical features of a surface and provides an overview of the parameters that are used to quantify them. Being able to reliably derive a set of parameters that describe the texture of biomaterial surfaces is a key aspect in the manufacture of safe and effective implantable medical devices that have the potential to trigger an adverse biological reaction in situ.
1.2This guide is not intended to apply to porous structures with average pore dimensions in excess of approximately 50 nm (0.05 μm).
1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.