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Significance and Use
The term “surface texture” is used to describe the local deviations of a surface from an ideal shape. Surface texture usually consists of long wavelength repetitive features that occur as results of chatter, vibration, or heat treatments during the manufacture of implants. Short wavelength features superimposed on the long wavelength features of the surface, which arise from polishing or etching of the implant, are referred to as roughness.
This guide provides an overview of techniques that are available for measuring the surface in terms of Cartesian coordinates and the parameters used to describe surface texture. It is important to appreciate that it is not possible to measure surface texture per se, but to derive values for parameters that can be used to describe it.
1.1 This 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.
1.2 This guide is not intended to apply to porous structures with average pore dimensions in excess of approximately 50 nm (0.05 μm).
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
C813 Test Method for Hydrophobic Contamination on Glass by Contact Angle Measurement
F2312 Terminology Relating to Tissue Engineered Medical Products
F2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2664 Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
Other StandardsISO13565–1 Geometrical Product Specifications (GPS)Surface Texture: Profile MethodSurfaces Having Stratified Functional Properties; Filtering and General Measurement Conditions
ICS Number Code 17.040.20 (Properties of surfaces)