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Implants for surgery. Total kneejoint prostheses -- Determination of endurance properties of knee tibial trays
This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface.
It applies to tibial trays which cover both the medial and lateral plateaux of the tibia.
The test method does not apply to tibial components manufactured solely from plastic materials.
This document does not cover methods of examining and reporting the final condition of the test specimen; these can be the subject of agreement between the test laboratory and the parties submitting the specimen for test.
Correlation of test results with in vivo performance has not been established.
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