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Validation of packing processes according to ISO 11607-2

The standard series ISO 11607 stipulates validation of the packaging processes used for industry, health care facilities and wherever medical devices are packaged and sterilized (examples of health care facilities include hospitals, doctors' and dentists' surgeries).

The ISO 11607, Part 2 standard (Article 5.1.1) explicitly calls for validation of all packaging processes.

To make sure your sealer meets the standard, read the guideline.