Project No.ISO 15747:2018
Title<p>This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.</p> <p>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.</p> <p>NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.</p>
Registration number (WIID)70727
Scope<p>This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.</p> <p>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.</p> <p>NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.</p>
StatusStandarts spēkā
ICS group11.040.20