The medical device industry requires extensive testing on packaging used to seal medical devices. These requirements are in place to minimize foreign substances from entering into the packaging. With respects to quality control efforts, barrier properties such as seal strength and peel strength are indicators of how well a container is sealed. This confirms leak prevention and shelf life properties of that packaging. The specific manner in which the peel test is done to determine the sealant properties of your product package is dependent of standards that must be met. These standards might be internally based, industry based, or requirement based. Testing in accordance with international standards Common standards to follow for medical device package testing include ISO 11607-1, ASTM F88, and ASTM F88. ISO 11607-1 is specifically used for sterile packaging, and it also outlines how to determine the seal strength of the material being used. ASTM F88 is a general standard for seal strength of materials used in packaging. This standard is not used with sterile packaging. ASTM D903 is another general standard for determining the adhesive strength of materials. Equipment required TestResources universal material testing machines are effectively used for determining the peel strength, bonding strength, and shear properties of adhesives. TestResources test machines meet the requirements specified in many standard test procedures for constant-rate-of-extension and constant-rate-of-load machines. This allows the machines to be programmed to perform many unique testing procedures.
Applicable Testing Standards
- ISO 11607 Packaging for Sterilized Medical Devices
- ASTM D903 180 degree Peel Strip Strength of Adhesive Bonds
- ASTM F88 Seal Strength Testing Equipment for Flexible Barrier Materials
Recommended Test Machine
Forces up to 10 kN (2,250 lbf)
Low force tabletop systems
Modular series of five frame options with adjustable test space
Affordable testing option for tension, compression, bend, peel and much more
Forces up to 5 kN (1,125 lbf)
Low force tabletop systems
Tests at speeds up to 2,500 mm/min (100 in/min)
Best for high travel or high elongation test requirements
Recommended Testing Accessories
Rated to 100 N (22 lbf)
Maximum specimen thickness of 18 mm (0.71 in)
Pneumatic design allows for quick specimen setup
Consistant clamping force between tests
Rated to 220 N (50 lbf)
Maximum specimen thickness of 8 mm (0.31 in)
Wider model allows for specimens thicknesses up to 46 mm (1.8 in)
Cost effective option for low force testing
Rated to 500 N (112 lbf)
Maximum specimen thickness of 6 mm (0.23 in)
Pneumatic design allows for quick specimen setup
Consistant clamping force between tests
Rated to 1 kN (225 lbf)
Maximum specimen thicknesses from 10 mm to 50 mm (0.39 in. to 2.0 in.)
Simple design can be used for a multitude of tensile applications
Inexpensive and reliable
