NF ISO 11040-7

NF ISO 11040-7

June 2024
Standard Current

Prefilled syringes - Part 7 : backaging systems for sterilized subassembled syringes ready for filling

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.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2024

Number of pages

34 p.

Reference

NF ISO 11040-7

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-006-7

Print number

1

International kinship

ISO 11040-7:2024
Sumary
Prefilled syringes - Part 7 : backaging systems for sterilized subassembled syringes ready for filling

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.

Replaced standards (1)
NF ISO 11040-7
June 2015
Standard Cancelled
Prefilled syringes - Part 7 : packaging systems for sterilized subassembled syringes ready for filling

ISO 11040-7:2015 specifies the 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 ISO 11040-7:2015.

Standard replaced by (1)
NF ISO 11040-7
June 2015
Standard Cancelled
Prefilled syringes - Part 7 : packaging systems for sterilized subassembled syringes ready for filling

ISO 11040-7:2015 specifies the 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 ISO 11040-7:2015.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences relatives au système d'emballage
  • 5 Marquage de la barquette
  • 6 Étiquetage
  • 7 Emballage des barquettes dans des unités/paquets de commercialisation
  • Annexe A Conception des présentoirs
  • Annexe B Conception des barquettes
  • Annexe C Représentations schématiques d'exemples de configurations de sachets de protection
  • Annexe D Conception et dimensions du sachet de protection pour les barquettes de 3" et 4"
  • Annexe E Positionnement de la barquette et pliage des sachets de protection intérieurs pour les barquettes emballées dans une configuration à sachet double
  • Bibliographie
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