EndoLab Test for Hip Prosthesis Covered by Scope of ISO 14242-4

Additive manufactured orthopedic implants

ISO 14242-4 specifies the test conditions necessary to simulate edge loading at steep acetabular cup inclination and dynamic separation conditions (microseparation). A spring system is used to generate this dynamic separation.

EndoLab’s test frame, as well as the linkage to the spring system, have been re-engineered from an existing set-up to meet the ISO 14242-4 standard.

Moreover, displacement measurements are performed by using high-accuracy digital sensors. Based on a successful validation, this test is now covered by the scope of EndoLab’s accreditation.

EndoLab offers a variety of technological implant testing services to develop and certify medical products. We are an accredited (DAkkS O-PL-18838-02-00) and certified (ZLG-P-944.98.07) test laboratory according to DIN EN ISO/IEC 17025 and 93/42/EWG. The company is a spin-off from the Technical University of Munich.

Source: EndoLab; image courtesy of EndoLab GmbH

 

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