The ISO 11607 standard was published by the International Organization for Standardization to guide medical device manufacturers and sterile packaging manufacturers on how to select and use appropriate packaging for terminally sterilized medical devices. The ISO 11607 standard consists of two parts: ISO 11607-1:2006(R)2010 Packaging for terminally sterilized medical devices, Part 1: Materials, sterile barrier systems and packaging systems and ISO 11607-2:2006(R) 2010 Packaging of Terminally Sterilized Medical Devices; Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes.