EN ISO 11607-2 pdf download Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) Scope This part of ISO 11607 specifies the requirements for development and validation of processes for packagingmedical devices that are terminally sterilized. These processes include forming, sealing, and assembly otpreformed sterile barrier systems, sterile barrier systems...