ISO 11607-01
Packaging for Terminally Sterilized Medical Devices
ISO 11607-01 is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607-01 to ensure that the enclosed medical device is kept sterile throughout all the elements and hazards generated by the manufacturing, shipping and storage environments.
The ISO 11607-01 standard has recently been revised to incorporate the provisions of the EN 868-1 standard. As a result, the new ISO 11607-01 is compromised of two parts:
- Part 1 - Materials & Designs
- Part 2 - 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.
Watch videos of the types of testing that packaging must withstand to comply with ISO 11607.
- Random Vibration Testing
- Seal Peel Testing
- Compression Testing
- Repetitive Shock Testing
- Leak Testing by Dye Penetration
- Bubble Leak Testing
- Drop Testing
Register here for a DDL webinar about the ISO 11607 Revisions.
You can also register here for a free article on how
revisions to ISO 11607 will affect manufacturers and package testing professionals.
For more information on the new ISO 11607-01 standard and how it will impact compliance requirements for package validation, register for your free packadvice or contact us.
