Essential New Definitions in AAMI/ISO 11607:2006
A key milestone in the 2006 revision of ISO 11607 was the development of new definitions to describe the various levels of packaging. Up until this time, a wide variety of terms and phrases were used, sometimes with multiple meanings across the industry.
In order to use this standard effectively, it is important to be aware of these definitions.
Packaging system. Combination of the sterile barrier system and protective packaging (ANSI/AAMI/ISO 11607-1:2006, definition 3.10).
Preformed sterile barrier system. Sterile barrier system that is supplied partially assembled for filling and final closure or sealing (ANSI/AAMI/ ISO 11607-1:2006, definition 3.11).
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Protective packaging. Configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use (ANSI/AAMI/ISO 11607-1:2006, definition 3.13).
Sterile barrier system. Minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use (ANSI/AAMI/ISO 11607-1:2006 definition 3.22).