Standard

ISO 8362-2:2024

Historical draft

Note: This standard has a new edition: ISO 8362-2:2024

Corrigendums and amendments are bought separately.

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Abstract

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. 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.

Document information

  • Standard from ISO
  • Published:
  • Expires:
  • Edition: 4
  • Version: 1
  • Document type: IS
  • ICS 11.040.20
  • ISO TC ISO/TC 76

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