EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 13175-3 testing. This part of ISO 13175 specifies requirements for monophasic hydroxyapatite bone substitutes, monophasic β-tricalcium phosphate bone substitutes, and biphasic hydroxyapatite/β-tricalcium phosphate bone substitutes in blocks or granules.
This part of ISO 13175 does not apply to cell seed bone void fillers, calcium phosphate cements or bone void fillers containing materials other than hydroxyapatite and β-tricalcium phosphate.
Hydroxyapatite and β-tricalcium phosphate synthetic bone substitutes are now considered an adequate alternative to autografts and allografts. Indeed, the synthetic origin of these devices ensures that no infectious disease will contaminate the patient.
Also, hydroxyapatite and β-tricalcium phosphate have been shown to be osteoconductive, meaning that if implanted in a bone site they will promote bone healing at the surface of the material. The biocompatibility of hydroxyapatite and β-tricalcium phosphate has been demonstrated by extensive literature.
The healing process in bone substitutes is not only related to the osteoconductive potential of the material, but also to the porosity structure. The macroporosities must be large enough and must be interconnected for bone growth to occur over the entire volume of the implant. The porosities also have an effect on the absorption rate of the ceramic: The higher the microporosity number, the higher the dissolution rate.
Since bone substitutes are not designed to carry heavy loads, their mechanical properties are not required. However, the blocks often need to be reshaped by the surgeon to fit the shape of the bony cavity. The bone substitute will have sufficient mechanical properties to be processed.
EUROLAB assists manufacturers with ISO 13175-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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