This part of ISO 11040 applies to

— tubing-glass barrels (single-chamber design) for injection preparations, and
— sterilized subassembled syringes ready for filling.

It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

This part of ISO 11040 also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with this part of ISO 11040 are intended for single use only.

Cross References:
ISO 21748:2017
ISO 7864
ISO 7886-1:2017
ISO 80369-1:2018
BS EN ISO 80369-1:2018
ISO 10993-7
ISO 80369-7
ISO 11040-5
ISO 720:1985
ISO 4802-2
ISO 9626
ISO 4802-1
ISO 8871-1
ISO 2859-1
ISO 11040-7
ISO 11135-1
ISO 11608-2
ISO 554
DIN 13097-4
ISO 14644-1
ISO 10993-1
ISO 11137
ISO 15378
ISO 14937
ISO 11608-5
GUM:1995
ISO 527-2
ISO 80369-7
AAMI ST72:2011
ISO 23908
ISO 11140
ISO 2039-2
ISO 180
ISO 3951
ISO 17665-1
ISO/IEC Guide 98-3:2008
ISO 178
ISO 7619-1


Incorporates the following:
Amendment, March 2020