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RS ISO 11608-6: 2022
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems

Abstract

This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needlebased
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).

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 11608-6: 2022	ADOPTED ISO STANDARDS	Health care technology	29	First Edition Jul 2026	Available