ISO 13356 and ISO 6474-1/2

ASTM F1089

Corrosion of surgical instruments

ASTM F1801

Corrosion fatigue testing of metallic implant materials

ASTM F1875

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

ASTM F2129

Corrosion test of small implants

ASTM F3044

Galvanic corrosion

ASTM F897

Fretting corrosion of osteosynthesis plates and screws

ASTM G102

Calculation of corrosion rates

ISO 13402

Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure

ISO 16429

Assessment of corrosion behaviour of metallic implantable materials

Ceramic specification

Normative References

ISO 13356: Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

ISO 6872: Dentistry – Ceramic materials

ISO 22214: Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for cyclic bending fatigue of monolithic ceramics at room temperature.

ISO 6474-1: Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina

ISO 6474-2: Implants for surgery – Ceramic materials – Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

 

These international standards specify the requirements and corresponding test methods for biocompatible and biostable ceramic bone-substitute material (e.g. yttria-stabilized tetragonal zirconia or high purity alumina) for use as a material for surgical implants.  

Contact Person male

Your contact person

Dipl. Ing. Christian Findeiss

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