EUROLAB laboratory provides testing and compliance services within the scope of ISO 13779-2 standard. This standard specifies requirements for single-layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants.
These requirements aim to define the properties of materials and communicate them between organizations. These requirements are not written to replace a company's internal operational and evaluation requirements, but they can be used as such.
The requirements for the hydroxyapatite layer of double-layer coatings (consisting of a lower metallic coating layer and an upper hydroxyapatite coating layer) can follow this document; however, the test methods referred to in this standard cannot be applied to double-layer coatings.
If this standard is taken as a reference for the hydroxyapatite layer requirements of double-layered coatings, a justification for how the single-layer tested coupons represents the double-layered-coated implant may be considered necessary.
This standard does not cover glasses, glass ceramics, coatings made of alpha and beta tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate.
Although the requirements in this standard are intended to be used as properties of a thermally sprayed hydroxyapatite coating, it may be necessary to establish control tests and routine control procedures specifying their time intervals to ensure that the properties of the coating remain within specified limits.
This standard was developed with a focus on plasma spray coating of hydroxyapatite. It can also be used to characterize other thermally sprayed hydroxyapatite coatings. However, thermally sprayed coatings without a history of clinical use may present different risks and need additional characterizations beyond those described in this standard.
EUROLAB assists manufacturers with ISO 13779-2 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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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
