New in the ISO 11607 series: Part 3 on packaging process development

A new part has been added to the ISO 11607 series on packaging for terminally sterilized medical devices.

ISO 11607-3:2026: Packaging for terminally sterilized medical devices – Part 3: Requirements for process development for forming, sealing and assembly was published in September 2026 as a first edition.

This new Part 3 focuses on the development of forming, sealing and assembly processes when heat-sealing technologies are used. It is intended to be applied before process validation, while ISO 11607-2 continues to address requirements for process specification and validation.

For medical device manufacturers, this new standard is an important development to be aware of when working on sterile barrier systems and associated packaging processes.