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UNE EN ISO 8536-2:2023
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023) (Endorsed by Asociación Española de Normalización in April of 2023.)
Equipo de infusión para uso médico. Parte 2: Cierres para botellas de infusión. (ISO 8536-2:2023) (Ratificada por la Asociación Española de Normalización en abril de 2023.)
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| Standard number: | UNE EN ISO 8536-2:2023 |
| Pages: | 23 |
| Released: | 2023-04-01 |
| Status: | Standard |
DESCRIPTION
UNE EN ISO 8536-2:2023
This part of ISO 8536 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 part of ISO 8536 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.