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 1        In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.
NOTE 2        Annex E provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.
NOTE 3        Annex F provides recommendations regarding sustainability.
NOTE 4        Annex G provides information on attributive and variable testing.