Mechanical Testing Equipment for Implantable Devices: Stents, Heart Valves, Pacemakers, and Contact Lenses

Implantable devices take many forms from cardiovascular, endovascular, neurovascular stenting, and associated delivery systems to heart valves and pacemakers, through to auditory and ocular implants, such as intraocular or contact lenses. Many of these devices are wonderful creations of modern medical engineering that aid physicians, surgeons, and medical specialists in the treatment of various diseases and conditions.

With stringent requirements from regulations, manufacturers must demonstrate that they have considered risks of device failure and satisfactorily mitigated against them. Mechanical testing of implantable devices is performed in vitro to aide designers and researchers in gathering performance data ahead of device approval and clinical use. Although mechanical testing does not begin to simulate the complete in vivo conditions that devices undergo, it does allow experimental validation and provides more accurate data for Finite Element Analysis (FEA) and computer modelling of them to be undertaken.

Mechanical testing takes many forms, from testing of the constituent metals and alloys to compression and flexural testing of complete devices, through to dynamic simulation of pressure pulsation. Some examples of testing configurations are:

Other testing solutions are available including use of standard testing system with universial fixtures, such as an XY-Stage or a Tapped Plate.

Testing systems that can be used for implantable devices include the 3340 and 3360 Series, 5940 and 5960 Series, and the ElectroPuls™ dynamic test instruments. Other testing systems, such as torsion, multi-axial and impact, can also be used.

3300 Universal Testing Systems

3342

The 3300 Series of mechanical testing systems provide the simplicity, performance, and affordability needed for quality control and production testing. From routine, standardized QC tests to general purpose mechanical testing, the 3300 family is the affordable solution for the modern laboratory.

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5900 Universal Testing Systems

5900

The 5900 Series are higher performance universal systems that are packaged in innovative frames, designed with enhancements that deliver superior accuracy and reliability, improved ergonomics, and an enhanced overall experience for the operator. Systems are packaged with Bluehill for test set-up, running of tests and data analysis.

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ElectroPuls™ Test Instruments

Electropuls

ElectroPuls systems use linear motor technology to offer slow-speed static testing and high-frequency dynamic fatigue testing with hundreds of Hertz capability. With models up to 10 kN and a linear-torsion variant, ElectroPuls systems are dynamic testing machines that do not have the environmental impact of conventional servohydraulic technologies.

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