EN ISO 11607-2:2006 pdf download.Packaging for terminally sterilized medical devices - Part 2:Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
One significant barrier to harmonization was terminology. The terms “package”, “final package”, “final pack”, “primary pack”, and “primary packag& all have different connotations around the globe and choosing one of
completion of this document. As a result, the term stenle barrier system” was introduced to describe the
sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier Systems” would include any partially assembled sterile barrier systems such as pouches, heade.
completion of this document. As a result, the term stenle barrier system” was introduced to describe the
sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier Systems” would include any partially assembled sterile barrier systems such as pouches, heade.
