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
Edición 2
2024-06
International Standard
Vista previa
ISO 11040-7:2024
82921
No disponible en español
Publicado (Edición 2, 2024)

ISO 11040-7:2024

ISO 11040-7:2024
82921
Idioma
Formato
CHF 129
Convertir Franco suizo (CHF) a tu moneda

Resumen

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.

Informaciones generales

  •  : Publicado
     : 2024-06
    : Norma Internacional publicada [60.60]
  •  : 2
     : 25
  • ISO/TC 76
    11.040.25 
  • RSS actualizaciones

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)