CARDIO-VASCULAR

The following overview shows many of the relevant standards in the field of cardio-vascular devices which are used for our Finite Element Analyses. In general, the FE Analyses are based on one or more of these standards in order to provide static and dynamic analyses of manufacturing, implantation and loading of the devices such as stents, stent grafts, heart valves or occluders. Physiological behavior of surrounding vessels can be simulated using mock artery models. Different material properties (e.g. Shape Memory Alloy Nitinol, elastic-plastic material CoCr or 316L) can be used to simulate cardio-vascular implant systems using FEA.

Stents and Stent Grafts:

ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents
ISO 25539-3: Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters
ASTM F2514: Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
ASTM F3067: Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
ASTM F2079: Elastic Recoil of Balloon-Expandable Stents
ASTM F3211: Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
FDA Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. April 18, 2010
FDA Guidance for Industry and FDA Staff: Reporting of Computational Modeling Studies in Medical Device Submissions. September 21, 2016

Heart Valves:

ISO 5840-3: Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 5910: Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices

Occluders:

ISO/CD 22679: Cardiovascular implants – Cardiac [MDSL id=2329] occluders test

HIP

In the field of hip implants there are several standards dealing with the examination of hip stems, hip balls or acetabular cups. Also a non-standardized test setup can be simulated using FEA.

ISO 7206-4: Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components
ISO 7206-6: Implants for surgery – Partial and total hip joint prostheses – Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ISO 7206-10: Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads
ISO 7206-12: Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells
ASTM F2996: Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
ASTM F2582: Standard Test Method for Impingement of Acetabular Prostheses
ASTM F2580: Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

KNEE

The Finite Element Analyses of artificial knee implants focusses on the femoral and tibial components of the implant. The list of standards below contains different test setups for the analysis of the devices.

ISO 14879-1: Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays
ASTM F1223: Determination of Total Knee Replacement Constraint
ASTM F3161: Finite Element Analysis (FEA) of Metallic Orthopaedic Knee Femoral Components under Closing Conditions
ASTM F1800: Cyclic Fatigue Testing of Metal Tibial Tray Components
ASTM F2724: Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
ASTM F3334: Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
ASTM F2083: Standard Specification for Knee Replacement Prosthesis

SPINE

The simulation of diverse spinal implant systems (e.g. cages, corpectomy models) is performed based on standards shown below.

ASTM F2077: Test Methods For Intervertebral Body Fusion Devices
ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.

ORTHOPEDICS

Besides knee, hip or spinal implants there are many other regions in the human body where implants are successfully used. Exemplarily this can be finger, ankle, shoulder or various osteosynthesis implants. See below for a selection of standards dealing with the test of different orthopedics implant types which can be analyzed using FEA.

Finger:

ASTM F1781: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants.

Ankle:

ASTM F2665: Standard Specification for Total Ankle Replacement Prosthesis

Shoulder:

ASTM F1825: Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear.
ASTM F2028: Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

Osteosynthesis:

ASTM F382: Standard Specification and Test Method for Metallic Bone Plates
ISO 9585: Determination of bending strength and stiffness of bone plates
ASTM F382: Standard Practice for Static Bend and Torsion Testing of Intramedullary Rods
ASTM F126: Standard Specification and Test Methods for Intramedullary Fixation Devices
ASTM F564: Standard Specification and Test Methods for Metallic Bone Staples.

DENTAL

In dentistry the loading of dental implant systems consisting of several components under preload with also varying abutment angles is FEA simulated based on the standard shown below.

ISO 14801: Dentistry – Implants – Dynamic loading test for endosseous dental implants
ISO/TS 13498: Dentistry – Torsion test of implant body/connecting part joints of endosseous dental implant systems