Abstract

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.

Begin

2024-04-02

WI

CSS03012

Planned document number

DIN EN ISO 15747 rev

Project number

17600094

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment