Prefilled syringes - Part 6: Plastic barrels for injectables
|Publication Date:||1 April 2012|
|ICS Code (Syringes, needles and catheters):||11.040.25|
This part of ISO 11040 specifies the materials, dimensions and requirements for plastic barrels (singlechamber design) for injection preparations, which are to be subsequently filled and assembled on standardized processing equipment.
It is applicable to pre-filled plastic syringes intended for single use only.
Pre-filled syringes can be produced on dedicated and specifically designed processing equipment. This part of ISO 11040 is not applicable to such dedicated pre-filled syringes.
Before the final approval for human use is granted, compatibility tests applying the intended pharmaceuticals are carried out. This part of ISO 11040 does not specify the procedures for such compatibility tests.