NF EN ISO 15747

NF EN ISO 15747

March 2019
Standard Current

Plastic containers for intravenous injections

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2019

Number of pages

26 p.

Reference

NF EN ISO 15747

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-105

Print number

1

International kinship

ISO 15747:2018

European kinship

EN ISO 15747:2019
Sumary
Plastic containers for intravenous injections

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.

This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

Replaced standards (1)
NF EN ISO 15747
March 2012
Standard Cancelled
Plastic containers for intravenous injections

<p>ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.</p> <p>ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.</p>

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Application des essais
  • Annexe A Essais physiques
  • Annexe B Essais chimiques
  • Annexe C Essais biologiques
  • Annexe D Perforateur de référence
  • Bibliographie
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