International Standard
ISO 11040-7:2024
Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
Reference number
ISO 11040-7:2024
Edition 2
2024-06
© ISO 2024
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Published (Edition 2, 2024)

ISO 11040-7:2024

Language
Format
CHF 129
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Abstract

This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.

Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document.

NOTE 1        Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.

NOTE 2        ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.

General information

  • Status
     : Published
    Publication date
     : 2024-06
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 25
  • Technical Committee :
    ISO/TC 76
    ICS :
    11.040.25 
  • 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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