Sterile barrier system

The sterile barrier system is what keeps a sterile device sterile until it is opened, so its design and validation sit with ISO 11607. ISO 13485 asks for packaging and sterile barrier processes to be validated and their records kept.

minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use [SOURCE: ISO 11607‑1:2006, 3.22]

ISO 13485:2016, clause 3.19