The standard specifies the shape, dimensions, material and labelling requirements as well as requirements for closures of infusion bottles, according to DIN EN ISO 8536-1. The requirements are supplemented by test methods for the determination of fragments, the determination of the spike penetration force as well as spike retention and sealability. The aim is to specify a compatible closure system, consisting of infusion bottles and closures, which complies with the high requirements for primary packaging components for medicinal products.
This standard has been prepared by ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" (secretariat: DIN), in cooperation with the CEN Management Centre (CMC), with the participation of German experts. At DIN the responsible Working Committee is NA 063-02-15 AA "Gummi" ("Rubber") of NAMed.