ISO 11607 Validation

ISO 11607 Validation Testing - Packaging for Terminally Sterilized Medical Devices

ISO 11607 is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607 to satisfy European regulations in order to obtain your CE Mark. Following ISO 11607 will ensure that the enclosed medical device is kept sterile throughout all the elements and hazards generated by the manufacturing, shipping and storage environments.

DDL has over 20 years of expertise in validating medical device packages to ISO 11607. Our engineers are ready to partner with you and consult on the most effective strategy to get your testing done right the first time.

Package validation tests needed to comply with ISO 11607

  • Transportation/Distribution Simulation Testing (Dynamics)
  • Package Strength Testing
  • Package Integrity Testing
  • Shelf-Life Testing (Accelerated Aging / Real Time Aging)

The ISO 11607 standard was revised in 2006 to incorporate the provisions of the EN 868-1 standard. DDL has thoroughly studied the revisions to be sure we're educated on the changes and what they mean to both the medical device manufacturer and the testing provider.

As a result, the new ISO 11607-01 is compromised of two parts:

Part 1: Requirements for materials, sterile barrier systems and packaging systems
Part 2: Validation requirements for forming, sealing and assembly processes

Medical device manufacturers and package testing professionals should take note of the revisions to the ISO 11607 standard, as the revisions could mean the difference between pass or fail when it comes to package testing and validation.

Have a question about ISO 11607? You're not the only one! DDL has received many questions from medical device manufacturers and package engineers regarding the ISO 11607-01 standard. Click here to view 15 of the most frequently asked questions about ISO 11607.

You can also contact us directly for questions about your testing. We're ready to talk to you about how the revisions to ISO 11607 may affect your packaging.


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