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.
NOTE 1 Although technically a device using a soft cannula is not “needle-based”, the soft cannula is placed by a needle and can be included in this classification.
NOTE 2 Some requirements and methods are already established and included in other parts of the ISO 11608 series.
Infusion pumps that are designed for continuous delivery at a specific rate required to achieve and/or maintain a desired plasma medicinal product concentration are excluded from this document. However, while this document is not intended to directly apply to these pump products, it does contain requirements and test methods that can be used to help design and evaluate them.
NOTE 3 They are covered by IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic).