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.