ASTM F1820

Disassembly forces of modular acetabular devices

Icon of the ASTM F1875 test

ASTM F1875

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

Icon of the ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

ASTM F2009

Modular connection disassembly test

ASTM F2068 (PI-98)

Requirements for femoral prostheses - Metallic implants

ASTM F2345

Femoral head fatigue test

ASTM F2580

Modular stem 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

ASTM F3738

Third body hip wear test

ISO 11491

Impact resistance femoral heads

ISO 14242-1

Hip wear test

ISO 14242-4

Microseparation test

ISO 21534

Particular requirements for joint replacement implants

Icon of the ISO 21535 test

ISO 21535

Hip range of motion

icon test description

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

Femoral stem fatigue test

ISO 7206-6

Femoral stem neck fatigue test

ISO 7206-8

Femoral stem fatigue test

PI-11

Insert compression fatigue / static test

PI-3

Acetabular cup luxation test

PI-58 (ISO 7206-8)

Femoral stem fatigue test

PI-87

FEA non-modular hip femoral stem - neck region

PI-99 (ASTM F2091)

Standard specification for acetabular prostheses

ISO 21535

Specific requirements for hip-joint replacement implants

Normative References

ISO 21535: Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint implants  

ISO 21535 has been fundamentally revised. It now serves as the go-to standard for all hip devices, and includes the relevant ASTM procedures. For submission to regulatory bodies worldwide, ISO 21535 (the so-called “hip umbrella standard”) is now the applicable guideline.

Additionally, the standard outlines the evaluation process for test results, which involves a multi-stage procedure. In particular, it requires the use of a reference implant (predicate device), which presents manufacturers with fundamentally new requirements.

Our specialists will be happy to assist you in selecting the worst-case combinations for testing and to be tested and in developing a test plan that meets the requirements of ISO 21535.  

Resources

Need help selecting which tests within ISO 21535 apply to your device? Use our test plan generator to filter the relevant tests for your specific device – Welcome to the hip implant test plan generator!

Normative Navigator Hip (#11)

(takes approx. 4 min)

To create a tailored test plan, please provide some information about your device.
If you’re unsure about a question, just leave it blank.

This generator is free to use. Please note that it is supplementary to the expertise of an RA professional.
We strongly recommend discussing the generated plan with your targeted regulatory authority before submission.

All information you provide will be used solely for generating your test plan and will not be shared with third parties.
If you require an NDA beforehand, please reach out via the contact form.

Once complete, you will receive a copy of your responses along with the generated test plan by email.

Contact Person male

Your contact person

Dipl. Ing. Christian Findeiss

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