ISO 21534

ASTM F1820

Disassembly forces of modular acetabular devices

ASTM F1875

Fretting corrosion testing of modular implants – Femoral stem-head interface

ASTM F2009

Modular connection disassembly test

ASTM F2068 (PI-98)

Requirements for femoral prostheses - Metallic implants

ASTM F2345

Femoral head fatigue test

ASTM F2580

Fatigue test

ASTM F2582

Impingement test

ASTM F2979

Bearing surface characterization of retrieved hard-on-hard hip prostheses

ASTM F2996

FEA non-modular hip femoral stem

ASTM F3018

Guide for assessment of hard-on-hard articulation THR devices

ASTM F3047M

High demand hip wear testing

ASTM F3090

Fatigue test of acetabular devices

ASTM F3446

3D frictional torque measurement of total hip joint prostheses

ISO 11491

Impact resistance femoral heads

ISO 14242-1

Hip wear test

ISO 14242-1

Third body wear test based on ISO 14242-1

ISO 14242-4

Microseparation test

ISO 21534

Particular requirements for joint replacement implants

ISO 21535

Hip range of motion

ISO 21535

Specific requirements for hip-joint replacement implants

ISO 7206-1

Classification and designation of dimensions

ISO 7206-10

Femoral head compression test

ISO 7206-12

Deformation test for acetabular shells

ISO 7206-13

Femoral head torsion test

ISO 7206-2

Hip surface analysis

ISO 7206-4

Fatigue test

ISO 7206-6

Fatigue test

ISO 7206-8

Fatigue test

PI-11

Insert compression test

PI-3

Luxation test

PI-58 (ISO 7206-8)

Fatigue test

PI-87

FEA non-modular hip femoral stem - neck region

PI-99 (ASTM F2091)

Standard specification for acetabular 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