Test Laboratory

What is the goal of a material test?

The aim of material testing of medical products is to ensure the quality, safety and reliability of the materials used. Testing identifies and minimizes potential risks and defects to ensure that the materials comply with the relevant standards and regulations. This ensures that the medical product packaging meets the requirements for its intended use and has no negative impact on patients. Material testing also helps in the development and improvement of medical products by providing information on the performance and functionality of the materials.

What happens during a material test?

There are various ways of testing the material:

Tensile test on film material according to ASTM D882, DIN EN ISO 527-1 and DIN EN ISO 527-3: Determination of the tensile properties and elasticity of film material to evaluate the suitability of the material for different sterilization methods and storage parameters.

Air permeability according to Gurley and according to ISO 5636-5, DIN EN ISO 11607-1 Annex C: Determination of the air permeability of porous material and testing of the air permeability of the film material to detect invisible damage to the material and evaluate the air permeability.

Testing of imprint and labeling according to ASTM F2252/F2252 M: Determination of the durability of imprints on the packaging or labels by applying and removing defined adhesive tape. This is to be evaluated particularly after sterilization, storage or air conditioning.

ÜTesting of printing and labeling according to ASTM D5264 (Sutherland Rub Test): Test strips of the printed material are subjected to an abrasion test with a defined number of cycles to evaluate the resistance of the print to reference material.

In which areas are material tests used?

Material tests are used in many areas where materials have to withstand certain stresses. At PAConsult, we particularly test the materials used in the packaging of medical products.

Material testing is an important component in many sectors to ensure the quality, safety and performance of the materials used. Material testing is used both in the development phase, packaging validation and for change assessments.

Standard: ASTM D882, ASTM F2252/F2252 M, DIN EN ISO 527-1, DIN EN ISO 527-3, DIN EN ISO 11607-1, ISO 5636-5, ASTM D5264, ASTM D6988

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