Status : Under development

Abstract

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.

General information

  • Status
     : Under development
    Stage
    : CD approved for registration as DIS [30.99]
  • Edition
     : 4
  • Technical Committee :
    ISO/TC 76
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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