1. Scope
1.1 This guide covers the chemical, physical, biological, and mechanical characterization requirements for biocompatible mineral- and ceramic-based scaffolds used as medical implants or to manufacture tissue-engineered medical products (TEMPs). The mineral and ceramic components may be precipitated or sintered. 1.2 The test methods contained in this guide have characterizations of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. These properties may be important for the performance of the device, especially if they affect cell retention, activity and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product. 1.3 This guide may be used as guidance in the selection of appropriate test methods for the generation of a raw material or original equipment manufacturer (OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product. 1.4 While a variety of materials can be used and added to the manufactured scaffold, the composition of the set scaffold shall contain mineral or ceramic components as its main ingredients. 1.5 This guide stipulates that the scaffold is homogeneous in nature. Any in-homogeneity or anisotropy of the device shall be declared in the manufacturers material and device specification. 1.6 This guide neither addresses the biocompatibility of the scaffold nor the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold. 1.7 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 requirements prior to use.
Mineral scaffolds, that is, beta-tricalcium phosphate or hydroxyapatite, are often used as implant material for bone regeneration and tissue engineering. While there are material standards, there is no standard or guide on the analysis of 3-D scaffold constructs.
Keywords
scaffold; mineral; ceramic; characterization; porometry; porosimetry; porosity; analysis; mechanical; composition; Hydroxyapatite; TCP; calcium phosphate
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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