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 packaged medical device is kept sterile throughout all the elements and hazards generated by the manufacturing, shipping and storage environments.
MDC Engineering Inc. Specializes in providing HFFS Packaging Machines, Tray Formers and Sealers for the Medical Device community. Each of our Machines is provided with a complete validation protocol to ensure you can get into production in a timely fashion as well as comply with ISO 11607. In addition, MDC Engineering Manufactures both Tensil Testers and Bubble Leak Testers for the purpose of meeting ISO 11607 and various ASTM test methods..
Transportation/Distribution Simulation Testing (Dynamics)
Package Strength Testing
Package Integrity Testing
Shelf-Life Testing (Accelerated Aging / Real Time Aging)
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. 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
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.