11 Frequently Asked Questions about ISO 11607-1

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ISO 11607-1 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607-1 in order to satisfy European regulations and obtain a CE Mark. ISO 11607-1 is also a FDA Recognized Consensus Standard which is used in satisfying portions of device premarket review submissions. Fulfilling the requirements within ISO 11607-1 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use.