This document specifies requirements to the safe handling and the physical@ chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries@ national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.