Part 6: On-body delivery systems - ISO 11608-6

ISO 11608-6 - Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems


This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.

The test methods include:

  • Annex A Test methods for adhesion
  • Annex B Dose delivery profiles

Annex C In vitro methods in relation to needle/cannula displacement