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

Recommended Testing Accessories