Part 1: Requirements for materials, packaging systems and sterile barrier systems
ISO 11607-1 outlines test methods for materials used as sterile barriers for medical device packaging. Sterile barrier systems of this type are intended to be sterile from manufacturing to point of use. This standard does not cover all requirements of manufacturing sterile barrier systems or quality assurance for the entire manufacturing process of sterile barrier packaging systems.
Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11607-2 expands on the requirements for medical device package process validation. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
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ISO 11607 requires a universal test machine such as the 100 Family or 220 Family Universal Test Machines for peel and tensile tests. TestResources engineers also recommend a sturdy mechanical vice grip, such as the G227 shown in the tabs below.
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
Satisfies the requirements of ASTM F88 and ISO 11607-1
Pneumatic design allows for quick specimen setup
Consistent 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
Standard sample widths of 0.50 in. and 1.00 in.
Other sample widths available upon request
Effective and simple to use
Blade replacement takes mere seconds
