Overview

This standard contains requirements related to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. It is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range from 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. The European Standard has been prepared by ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use", in collaboration with CEN/TC 205 "Non-active medical devices" with the participation of German experts. At DIN the responsible committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und -geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics") of NAMed. Only the content of Annex ZA has been modified in this new edition of the standard.

Document: references other documents

Document: referenced in other documents

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/BT - BT Technical Board