DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

ISO 11040-7:2024

Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling

Jun 3, 2024

General information

60.60     Jun 3, 2024

ISO

ISO/TC 76

International Standard

11.040.25  

English   French  

Buying

Published

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11040-7:2015

NOW

PUBLISHED
ISO 11040-7:2024
60.60 Standard published
Jun 3, 2024