nsBAS EN ISO 21649:2024

Needle-free injection systems for medical use - Requirements and test methods


General information
Status:Project
Number of pages:43
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.20, Transfusion, infusion and injection equipment

Abstract
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. Excluded from this document are drug delivery methods which: —    involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); —    generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); —    deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); —    apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); —    infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.

Lifecycle
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Original document and degree of correspondence
EN ISO 21649:2023, identical
ISO 21649:2023, identical

Relation to BAS standards

Work material

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