20/30387730 DC

This standard 20/30387730 DC BS EN ISO 11608-4. Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters

This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software.

The needle-based injection system containing electronics can be single use, reusable, and/or rechargeable. It is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).

This document applies to electronic accessories which are intended to be physically connected to a NIS or NIS-E during the NIS/NIS-E intended use.