Air Impermeability

Air Impermeability is measured using a Gurley porosity meter.

ISO 11607 contains a requirement that "impermeable materials for sterile barrier systems shall be tested for air permeance." The method refers to the older style cylinder-type Gurley porosity meters and has a requirement that "after not less than one hour there shall be no visible movement of the cylinder." The ISO 11607 guidance document states that "demonstrating that the material is impermeable shall satisfy the microbial barrier requirement."

ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging