ISO 21534

ASTM F1223

Knee constraint test

ASTM F1672 (PI-95)

Patella specification

ASTM F1814

Test of modular knee implants

ASTM F2009

Modular connection disassembly test

ASTM F2722

Fatigue test baseplate/bearing fixation under torsional loading

ASTM F2723

Fatigue test baseplate/bearing fixation

ASTM F2724

Dislocation mobile bearing

ASTM F2777

Fatigue test under high flexion

ASTM F3140

Unicondylar tibial tray fatigue test

ASTM F3141

Knee loading profiles

ASTM F3161

FEA knee femoral component

ASTM F3210 / PI-73

Knee condyle fatigue test

ASTM F3334

FEA Tibial component

ASTM F3495

Ceramic knee failure load

ISO 14243-1/3

Knee wear test

ISO 14243-5

Durability performance patellofemoral joint

ISO 14879-1 / ASTM F1800

Tibial tray fatigue test

ISO 21534

Particular requirements for joint replacement implants

ISO 21536

Specific requirements for knee-joint replacement implants

ISO 7207-2

Knee surface analysis

PI-17

Knee contact pressure test

PI-53

Stemmed femoral knee component fatigue test

PI-96 (ASTM F2083)

Knee specification

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