The new standard ISO 11607-3:2026 – Packaging for Terminally Sterilized Medical Devices – Part 3: Requirements for Process Development for Forming, Sealing and Assembly has been released, introducing requirements for the development of heat-sealing processes used in medical device packaging.
The standard applies to packaging intended for medical devices that undergo terminal sterilization and focuses on the development of forming, sealing and assembly processes using heat-sealing technologies.
ISO 11607-3:2026 also recommends minimum features for heat-sealing equipment to support subsequent process validation, control and monitoring. It establishes a risk-based approach, using the sterile barrier system specification to develop the corresponding process specification.
Importantly, the standard is intended to be applied before process validation, helping manufacturers establish appropriate process requirements and equipment capabilities at an early stage.
Manufacturers of terminally sterilized medical devices should consider the new standard when developing or updating their packaging processes to support consistent sealing performance and the integrity of sterile barrier systems.
More information can be found using the following link
