Full Description

BS ISO 11040-6:2019 specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.

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

Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document.

Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.


Cross References:
ISO 7864:2016
ISO 9626
ISO 14971
ISO 8871-1
ISO 80369-1
ISO 10993-1
ISO 7886-1
ISO 80369-7
ISO 11040-4
ISO 13926-2
ISO 80369-20
ISO 7619-1
ISO 13485
ASTM D7210-06
ISO 17665-1
ISO 11040-7
ISO 3951 (all parts)
ISO/IEC Guide 98-3
ISO 11137 (all parts)
ISO 10993-7
ISO 11040-5
ISO 14644-1
ISO 15378
ISO 15747
ISO 2859-1
ISO 11135
ISO 14937
ISO 3826-1
AAMI ST72:2011


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 01/11/2019 ISBN(s): 9780580978838 Number of Pages: 62 File Size: 1 file , 1.7 MB Product Code(s): 30357742, 30357742, 30357742 Note: This product is unavailable in United Kingdom