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ISO 21649:2023


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ISO 21649:2023 Needle-free injection systems for medical use - Requirements and test methods

standard by International Organization for Standardization, 01/01/2023

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This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.

The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.