NF EN ISO 8362-4

NF EN ISO 8362-4

December 2004
Standard Cancelled

Injection containers and accessories - Part 4 : injection vials made of moulded glass

ISO 8362-4:2003 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements for the containers. It applies to colourless or amber glass containers moulded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2004

Number of pages

16 p.

Reference

NF EN ISO 8362-4

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-110-4

Print number

1 - 12/11/2004

International kinship

ISO 8362-4:2003

European kinship

EN ISO 8362-4:2004
Sumary
Injection containers and accessories - Part 4 : injection vials made of moulded glass

ISO 8362-4:2003 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements for the containers.

It applies to colourless or amber glass containers moulded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.

Replaced standards (1)
NF EN 28362-4
September 1993
Standard Cancelled
Injection containers for injectables and accessories. Part 4 : injection vials made of moulded glass.

Standard replaced by (1)
NF EN ISO 8362-4
November 2011
Standard Current
Injection containers and accessories - Part 4 : injection vials made of moulded glass

<p>ISO 8362-4:2011 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements for the containers.</p> <p>ISO 8362-4:2011 applies to colourless or amber glass containers moulded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Dimensions et désignation
    2
  • 4.1 Flacons d'injection pour insuline
    2
  • 4.2 Flacons d'injection pour antibiotiques
    3
  • 5 Matériau
    5
  • 6 Défauts, surfaces de scellage
    5
  • 7 Exigences de performance
    6
  • 7.1 Résistance hydrolytique
    6
  • 7.2 Résistance à la pression interne
    6
  • 7.3 Résistance au choc thermique
    6
  • 7.4 Qualité de recuit
    6
  • 8 Marquage
    6
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