Laboratory services

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We offers wide rang of laboratory services for medical device testing.

Mechanical forces testing:

• Film tensile strength

The thin film is pulled until it breaks in order to measure elongation, tensile modulus, tensile yield strength, and tensile strength at break.

• Compression test

By applying pressure on various materials or components to measure the breaking point.

• 4 point and 3-point bending

Bend testing is performed in order to measure yield point and flexural strength on all types of product and materials.

• Sutures mechanical properties:

  • Knot pull (U.S.P)

    Knot pull is tested by creating a knot in the middle of the test area and pull until reaching breaking point

  • Suture tensile strength

    Suture tensile strength test is a key element in determine the sutures required material.

  • Needle Pullout test

    This destructive test is to evaluate the required tension force to break the needle.

 

Biodegradable implants tests:

• Degradation Profile Tests

The degradation behavior of every bio-degradable material has a pattern that can be measured in order to better understand implementation period and the processes that the material is going through when it contacts body fluid.

• Moisture analysis.

  This test is used to determine the water content of a materials. The sample is being dried to a constant mass at pre-defined temperature.

• Erosion test

  This test examines erosion profile of biodegradable components, sutures weight loss during a total time period.

• This test examines the number of cycles needed to raise the coefficient of friction.

 

Coating tests:

• Coefficient of friction.

  This test examines the number of cycles needed to raise the coefficient of friction.

• Coating integrity.

  This test examines the layers of the coating and whether it has missing spots.

• Adhesion test for coating or catheter connecting point.

  This test examines the forces connecting between the substrate and the coating.

General testing:

• Extractable study.

  This study’s purpose is to screen and monitor presence of toxic materials according to FDA regulations.

• Shelf life acceleration.

  The test is performed with elevated temperature and specific Humid conditions to predict product shelf-life at typical storage conditions.

• Viscosity Measurement.

  The viscosity of a fluid is a measure of its resistance to gradual deformation by shear stress or tensile stress.

Packaging Validation:

• Peel test

  This test is to examine the force needed to open the package seal, which can compromise the product sterilization.

• Dye leak test

  This test determines the integrity of the package seal and reassures that there are no channels that leak in the pouch seal.

• Humidity test

  When dealing with biodegradable products humidity test of the package is essential for the product desired shelf life.

• Burst test

  This test determines package strength by pressurizing air into the package until it bursts.