DIN EN ISO 11607-2-2006 最后灭菌的医疗器械的包装.第2部分:组成、密封和装配过程的确认和要求(ISO 11607-2:2006)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) English version of DIN EN ISO 11607-2:2006-07
This standard specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.