ISO 21534

ASTM F1717

Spine corpectomy model

ASTM F1798

Spinal implants - interconnections mechanisms and subassemblies

ASTM F2077

Spinal cage test

ASTM F2193

Spinal components

ASTM F2267

Spinal implants subsidence test

ASTM F2346

Spinal disc static and fatigue test

ASTM F2624

Extra discal motion preserving implants

ASTM F2694 / F2790

Lumbar total facet prostheses

ASTM F2706

Occipital-cervical and occipital-cervical-thoracic model

ASTM F2789

Mechanical and functional characterization of nucleus devices

ASTM F3295

Impingement wear testing of total disc prostheses

ASTM F3631

Cage impact test

ISO 12189

Spine corpectomy model with anterior support

ISO 18192-1

Spinal disc wear test

ISO 18192-2

Nucleus replacement wear test

ISO 18192-3

Impingement-wear testing of lumbar prostheses

ISO 21534

Particular requirements for joint replacement implants

ISO 23089-2

Spinal cage pre-clinical mechanical assessment

PI-52

Expulsion test

PI-76

Spinous process plates

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