NF EN ISO 8536-2

NF EN ISO 8536-2

February 2023
Standard Current

Infusion equipment for medical use - Part 2 : closures for infusion bottles

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.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2023

Number of pages

26 p.

Reference

NF EN ISO 8536-2

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-2

Print number

1

International kinship

ISO 8536-2:2023

European kinship

EN ISO 8536-2:2023
Sumary
Infusion equipment for medical use - Part 2 : closures for infusion bottles

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.

Replaced standards (1)
NF EN ISO 8536-2
August 2010
Standard Cancelled
Infusion equipment for medical use - Part 2 : closures for infusion bottles

<p>ISO 8536‑2:2010 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.</p> <p>The dimensional requirements are not applicable to barrier-coated closures.</p> <p>Closures specified in ISO 8536‑2:2010 are intended for single use only.</p>

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Formes et dimensions
  • 5 Désignation
  • 6 Matériau
  • 7 Exigences
  • 8 Étiquetage
  • Annexe A (normative) Essai de fragmentation
  • Annexe B (normative) Détermination de la force de perforation du trocart
  • Annexe C (normative) Tenue du trocart et étanchéité autour du trocart
  • Annexe D (normative) Dispositif de perçage du bouchon
  • Bibliographie
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