Standards Development

Scope

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 valid action, 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 in ten d ed to be used prior to process validation.

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

Purpose

ISO 11607-1 and ISO 11607-2 specify requiremen ts for the design and validation of sterile barrier systems for terminally sterilized medical devices, and the validation requirements for manufacturing processes of sterile barrier systems. The heat sealing of a sterile barrier system is critical to the maintenance of sterile barrier integrity to the point of use, however, there is little content available for process development in the current standards.

This document specifies requiremen ts for the development of heat sealing processes to meet sterile barrier seal design requiremen ts with a h ig h level o f capability. Additionally, this document specifies requirements fo r d o cumen tin g th e eq uivalen ce o f sealin g processes. Specified requirements for these topics is essential to ensure the safety of terminally sterilized medical devices.