Laboratory services


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.

Laboratory services

Laboratory services

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.

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