ÖNORM EN ISO 11608-1:2022 10 15
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Needle-based injection systems for medical use — Requirements and test methods Part 1: Needle-based injection systems (ISO 11608-1:2022)
10-15-2022
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
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