ISO 21534

ASTM F1378

Shoulder specification

ASTM F1829

Shoulder glenoid shear

ASTM F2009

Modular connection disassembly test

ASTM F2028

Shoulder glenoid loosening

ISO 21534

Particular requirements for joint replacement implants

PI-61

Reverse shoulder implant wear test

PI-62

Anatomic shoulder implant wear test

PI-89

Resistance to static load of ceramic humeral heads

PI-90

Resistance to torque off head fixation of modular humeral prostheses

Particular requirements for joint replacement implants

Normative References

ISO 21534: Non-active surgical implants – Joint replacement implants – Particular requirements
ISO 4287: Geometrical Product Specifications (GPS) – Surface texture: Profile method – Terms, definitions and surface texture parameters
ISO 7206-4: Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties of stemmed femoral components
ISO 7206-8: Implants for surgery – Partial and total hip joint prostheses – Part 8: Methods of determining endurance performance of stemmed femoral components
ISO 14155-1: Clinical investigation of medical devices for human subjects – Part 1: General requirements
ISO 14242-1: Implants for surgery – Wear of total hip-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests
ISO 14242-2: Implants for surgery – Wear of total hip joint prostheses – Part 2: Methods of measurement
ISO 14243-2: Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement
ISO 14630: Non-active surgical implants – General requirements
ISO 14879-1: Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays
 

The standard provides particular requirements for joint replacement implants. Amongst others, test services evaluating the geometrical, fatigue and wear properties of joint replacement implants are provided by EndoLab®.  

Contact Person male

Your contact person

Dipl. Ing. Christian Findeiss

Head of Fatigue Testing & Material Analysis, Head of Vascular Testing