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Standard

ISO 8536-6:2025

Historisk utkast

Merknad: Denne standarden har en ny utgave: ISO 8536-6:2025

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. 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 be strongly affected by the nature and performance of the primary packaging.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Utgave: 4
  • Versjon: 1
  • Varetype: IS
  • Products.Specs.pages
  • ICS 11.040.20
  • ISO TC ISO/TC 76

Produktrelasjon

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