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Implant Testing

Accreditation

SpineServ GmbH & Co. KG is accredited according to 93/42/EWG and DIN EN ISO/IEC 17025 (www.dakks.de) which is an accreditation accepted by the FDA.

Mechanical Testing of Endoprostheses

Also standardized (ASTM, ISO) oder individual mechanical testing of endoprostheses is carried out in the SpineServ laboratories:

Hip (Download Summary)

Fatigue Testing of Stemmed Femoral Components ISO 7206-4
Fatigue Testing of the Head and Neck Region ISO 7206-6
Fatigue Testing of Modular Hip Components ASTM F2850
Impingement Test ASTM F2582
Femoral Head Static Compression Test ISO 7206-10
Impact Resistance of Ceramic Femoral Heads ISO 11491
Static Transverse Loading of the Acetabular Shell ISO 7206-12
Static Torque Resistance of Head Fixation ISO 7206-13
Disassembly Force of Taper Connections ASTM F2009
Disassembly Force of a Modular Acetabular Device ASTM F1820
Fretting Corrosion Test ASTM F1875
Finite Element Analysis of Hip Femoral Stems ASTM F2996
Standard Specification ASTM F2068
Specific Requirements ISO 21535

Knee (Download Summary)

Total Knee Replacement Constraint ASTM F1223
Cyclic Testing under Torsion ASTM F2722
Cyclic Testing under Shear Load ASTM F2723
Mobile Bearing Dislocation ASTM F2724
Cyclic Testing under High Flexion ASTM F2777
Fatigue Testing of Tibial Trays ISO 14879-1, ASTM F1800
Fatigue Testing of Stem Extensions S-05
Fatigue Testing of Femoral Components S-06
Testing of Modular Components ASTM F1814
Finite Element Analysis of Femoral Componenta ASTM F3161
Specific Requirements ISO 21536

Shoulder (Download Summary)

Glenoid Locking Mechanism in ShearASTM F1829
Dynamic Evaluation of Glenoid LooseningASTM F2028

 

 

 

Accreditation

SpineServ GmbH & Co. KG is accredited according to 93/42/EWG and DIN EN ISO/IEC 17025 (www.dakks.de) which is an accreditation accepted by the FDA.