ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark. ISO 11607 is also an FDA Recognized Consensus Standard. Fulfilling the requirements within ISO 11607 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use.
ISO 11607 testing consists of four key areas:
- Stability Testing (accelerated aging and real time aging)
- Performance/Dynamics Testing
- Package Strength Testing
- Package Integrity Testing
This ISO standard also addresses packaging materials by presenting requirements for their physical properties and material performance.
Interpreting ISO 11607 can be challenging. DDL specializes in ISO 11607 package validation testing and is happy to assist customers better understand this testing, the available options and how to carry out packaging validation projects completely and cost effectively.
With two full-service dynamic and integrity labs equipped with a wide range of environmental chambers and materials testing capabilities, DDL offers the medical device industry a combination of technical expertise, quality and industry knowledge designed to provide device manufacturers with the best service possible.
Contact us for more information or to talk to an engineer.