EUROLAB laboratory provides testing and compliance services within the scope of ISO 20795-2 standard. Methacrylate-based polymeric materials have been widely used in the construction of both active and passive removable orthodontic appliances for many years. These removable appliances are mainly used in the orthodontic treatment of children.
The method of preparing the polymeric portion of the orthodontic appliance has several potential problems. Depending on the polymerization process and the polymer/monomer mixing ratio, the polymer portion of the removable orthodontic appliance may be weaker than when using conventional bottling and polymerization heat systems.
A device may have a higher risk of having residual material such as monomers than a conventional thermoset denture base polymer. In addition, the high monomer content of the polymer/monomer mixture can cause increased shrinkage in polymerization.
Specific qualitative and quantitative requirements to be biohazard-free are not included in this part of ISO 20795, but it is recommended to refer to ISO 10993-1 and ISO 7405 in the assessment of potential biological or toxicological hazards.
This part of ISO 20795 applies to and specifies requirements for orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances. It also specifies the test methods to be used in determining compliance with these requirements. It also specifies requirements for packaging and marking of products and instructions to be provided for the use of these materials.
EUROLAB assists manufacturers with ISO 20795-2 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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