NF EN ISO 8362-5

NF EN ISO 8362-5

April 2016
Standard Current

Injection containers and accessories - Part 5 : freeze drying closures for injection vials

ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which 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 part of ISO 8362 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.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2016

Number of pages

17 p.

Reference

NF EN ISO 8362-5

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-112-5

Print number

1

International kinship

ISO 8362-5:2016

European kinship

EN ISO 8362-5:2016
Sumary
Injection containers and accessories - Part 5 : freeze drying closures for injection vials

ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which 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 part of ISO 8362 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.

Replaced standards (1)
NF ISO 8362-5
December 2008
Standard Cancelled
Injection containers and accessories - Part 5 : freeze drying closures for injection vials

Le présent document constitue la partie 5 de la série de normes ISO 8362, parues sous le titre général de "Récipients et accessoires pour produits injectables". Le présent document spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons de flacons pour produits injectables faisant l'objet des normes NF EN ISO 8362-1 et NF EN ISO 8362-4, utilisés pour les médicaments et les produits biologiques à lyophiliser. Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur. Les bouchons faisant l'objet du présent document sont à usage unique. Le présent document est une révision technique de la norme ISO 8362-5 de 1995.

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Forme et dimensions
  • 5 Désignation
  • 6 Matériau
  • 7 Exigences de performance
  • 8 Étiquetage
  • Annexe A Détermination de la teneur en humidité
  • Bibliographie
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