Our ISTA and ISO 17025-certified package testing laboratory provides medical device package validation testing in accordance with ISO 11607, the principle guidance for validating terminally sterilized medical device packaging. ISO 11607 requires medical device manufacturers to demonstrate the efficacy of their proposed sterile barrier packaging.

ISO 11607 is divided into two parts – Part 1, Requirements for Materials, Sterile Barrier Systems and Packaging Systems, and Part 2, Validation for Forming, Sealing, and Assembly Processes. ISO 11607 improves the flow of package qualification and process validation by defining and harmonizing four key terms used in both parts of the standard:

For sterile barrier packaging systems, ISO 11607 Part 1 Design and Development outlines four key requirements:

  • ISO 11607 Stability Testing: Real-Time Aging and Accelerated Aging (ASTM F1980) to demonstrate the sterile barrier system maintains integrity over time for the anticipated shelf life of the product
  • ISO 11607 Performance Testing: ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage
  • ISO 11607 Package Strength Testing: Physical tests to demonstrate the mechanical performance of the sterile barrier system
  • ISO 11607 Package Integrity Testing: Physical tests to demonstrate the sterility and integrity of the sterile barrier system

Environmental conditioning, accelerated aging and distribution simulation provide a controlled means to expose a packaging system to environmental and dynamic stresses that the packaging system may encounter in the field. Package strength testing and package integrity testing evaluate the packaging after such exposure.

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