ISO 11607-1-2:2006

ISO 11607-1:2006 that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.