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. NOTE Upon implementing this document, readers are encouraged to consider measures to actively reduce the use of natural resources and minimize the ecological footprint to increase sustainability. In that respect, Annex F provides recommendations of points to consider, from materials of construction and design, to testing strategy and sampling size.