This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.

This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.

This document applies to both preformed sterile barrier systems and sterile barrier systems.

This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.

This document is intended to be used prior to process validation.

NOTE            ISO 11607-2 provides requirements for process specification and process validation.