EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 13116 testing. ISO 13116 specifies test methods for determining the radio-opacity of a test material with reference to a sample of an aluminum standard.
The method is designed to discriminate radio-opacity at a clinically relevant level and is not designed to take into account factors that may affect the precise, inherent values of radio-opacity, such as background noise, X-ray beam power, grayscale correction, and image.
It is recognized that such factors can change the radio-opacity value, but not the relative ordering compared to the standard thicknesses of an internal standard such as aluminum. This test can be performed with conventional or digital sensing techniques of the dental x-ray machine.
Details of suitable molds are specified in the appropriate product standard. Typically, molds for specimens suitable for use in this test have a thickness ranging from 0,5 mm to 2,5 mm with straight right-angled edges. Samples should be homogeneous and of uniform thickness, but shape and size are not critical provided there is enough room for a determination to be made and samples can be placed close to the center of the film or sensor.
This International standard does not set pass/fail limits for radio opacity. If a manufacturer claims that a material is radio-opaque, the radio-opacity must have a value at least equivalent to the minimum level specified in the appropriate product standard requirements.
EUROLAB assists manufacturers with ISO 13116 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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