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Shoulder implants
 

Shoulder specification - ASTM F1378Shoulder specification - ASTM F1378 Shoulder glenoid shear - ASTM F1829Shoulder glenoid shear - ASTM F1829 Shoulder Glenoid Loosening - ASTM F2028Shoulder Glenoid Loosening - ASTM F2028 Reverse shoulder implant wear test - PI-61Reverse shoulder implant wear test - PI-61 Anatomic shoulder implant wear test - PI-62Anatomic shoulder implant wear test - PI-62 Particular requirements for joint replacement implants - ISO 21534Particular requirements for joint replacement implants - ISO 21534 Resistance to Static Load of Ceramic Humeral Heads - PI-89Resistance to Static Load of Ceramic Humeral Heads - PI-89 Resistance to Torque Off Head Fixation of Modular Humeral Prostheses - PI-90Resistance to Torque Off Head Fixation of Modular Humeral Prostheses - PI-90

Resistance to Static Load of Ceramic Humeral Heads - PI-89

Normative References  



PI-89 (ISO/CD 24085-1): Implants for Surgery - Partial and total shoulder joint prosthesis - Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres

ISO/CD is a draft standard to determine ceramic heads’ fracture load for total or partial shoulder joint replacement. The current version is covered by our scope of certification as PI-89.
The test method considers the non-axial loads and the mostly non-rotationally symmetrical designs of the implants. The number of test samples is based on statistical analysis. In addition, the determination of an acceptance criterion is described.  


Implant Testing - Resistance to Static Load of Ceramic Humeral Heads - PI-89


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