DIN EN ISO 11608-1:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022); German version EN ISO 11608-1:2022

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used for single-patient to deliver discrete volumes (bolus) of medicinal product, through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This document serves as the master standard and is the starting point for satisfying the requirements outlined in this and subsequent parts of the ISO 11608 series. Stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document, but with further exceptions. For example, other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function. In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.