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Abstract Preview

This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.


General information

  • Status :  Published
    Publication date : 2019-05
  • Edition : 2
    Number of pages : 7
  • Technical Committee
    :
    ISO/TC 76
    Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • ICS :
    11.040.25
    Syringes, needles and catheters

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A standard is reviewed every 5 years



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