Full Description

This document 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.