Material Test

What is the goal of a material test?

The goal of material testing for medical devices and their packaging is to ensure the quality, safety, and reliability of the materials used. Through medical device testing, potential risks and defects are identified and minimized to ensure that the materials comply with relevant standards and regulations. This ensures that medical device packaging meets the requirements for its intended use and has no adverse effects on patients. Material testing also aids in the development and improvement of medical devices and packaging by providing information about the performance and functionality of the materials.

What happens during a material test?

There are different ways to test the material:

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

Air permeability according to Gurley, in accordance with ISO 5636-5, DIN EN ISO 11607-1 Annex CDetermination of the air permeability of porous material and testing of the air permeability of the film material in order to detect invisible damage to the material and to evaluate the air permeability.

Inspection of printing and labeling in accordance with ASTM F2252/F2252 MDetermination of the durability of print on packaging or labels by applying and removing defined adhesive tape. This is to be evaluated particularly after sterilization, storage, or climate conditioning.

Inspection of imprint and labeling according to ASTM D5264 (Sutherland Rub 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 against reference material.

In which areas are material tests used?

Material testing is used in many areas where materials must withstand certain loads. At PAConsult, we specifically conduct medical device testing on materials used in medical device packaging.

Material testing is an important component in many industries to ensure the quality, safety, and performance of materials used. Material tests are employed in the development phase, packaging validation, and for change evaluations.

Standards: 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