DANSK DS/ISO 11040-6 PDF

This part of ISO 11040 applies to plastic barrels (single-chamber design) for injection preparations to be subsequently filled and assembled on standardized processing equipment and specifies materials, dimensions and performance details. Pre-filled plastic syringes in accordance with this part of ISO 11040 are intended for single use only. Before the final approval for human use may be granted, compatibility tests applying the intended pharmaceuticals are carried out. However, this part of ISO 11040 does not specify the procedures for such compatibility tests. NOTE – It is to be recognized that prefilled syringes can be produced on dedicated and specifically designed equipment, e. g. fully integrated processing equipment. This part of ISO 11040 does not cover the requirements for such dedicated prefilled syringes.