CYTOTOXICITY TESTING (CELL VIABILITY ASSAY)​

 

*  In vitro toxicity testing is the scientific analysis of the effects of toxic chemical substances on mammalian cells.
*  ISO 10993-5:2009; Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
*  These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. It is designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

HYDROXYAPATITE COATING CHARACTERIZATION

Characterizations of plasma sprayed hydroxyapatite which involve phase content, crystallinity, surface morphology, microstructure and mechanical properties (SEM, EDX, XRD and adhesion).

ASTM F2024 - 10(2016) : Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

This practice is for the determination, by the Reference Intensity Ratio External Standard Method, of the percent by weight of the crystalline phases, hydroxyapatite (HA), beta-(whitlockite) tricalcium phosphate (β-TCP), and calcium oxide (CaO) in coatings deposited upon metallic substrates by plasma-spraying hydroxyapatite

FABRICATION OF CALCIUM PHOSPHATE MATERIAL (POWDER) : HYDROXYAPATITE, β- TRICALCIUM, BIPHASIC CALCIUM PHOSPHATE

 Calcium phosphate materials are used in many medical and dental applications such as coatings, fillers and so on. These materials are similar to bone in composition and having bioactive and osteoconductive properties. Calcium phosphate material will be synthesized using wet chemical technique. Characterizations of the synthesized powder will also be conducted using - X-ray diffractometer (XRD), Field Emission Scanning electron Microscope (FESEM), Energy Dispersive X-ray (EDX) and Fourier Transformation Infra-red (FTIR)

;ASTM F1609 - 08(2014): This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.

In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization. This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: mechanical capture, plasma spray deposition, dipping/sintering, electrophoretic deposition, porcelainizing, and sputtering.

Substrates may include smooth, porous, textured, and other implantable topographical forms. This specification excludes organic coatings that may contain calcium and phosphate ionic species. Materials shall be tested and the individual grades shall conform to chemical requirements such as elemental analysis fo r calcium and phosphates, and intentional additions, trace element analysis for hydroxylapatite and beta tricalcium phosphate; crystallographic characterization such as Fourier Transform infrared spectroscopy, and environmental stability; physical characterization such as coverage of substrate, thickness, porosity, color, surface topography, and density; and mechanical characterization such as tensile bond strength, shear strength, and fatigue strength. The test specimen fabrication and contact with calcium phosphate coatings are also detailed.​​​​