BS EN ISO 8536-2:2023 - TC

This standard BS EN ISO 8536-2:2023 - TC Tracked Changes. Infusion equipment for medical use is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE       The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.