DS/EN ISO 21649

Needle-free injectors for medical use - Requirements and test methods

active, Most Current
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Organization: DS
Publication Date: 22 October 2009
Status: active
Page Count: 50
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the injection system 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 also may be a permanent internal chamber designed to last through the claimed life of the device. Excluded from this International Standard 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.

Document History

DS/EN ISO 21649
October 22, 2009
Needle-free injectors for medical use - Requirements and test methods
This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other...
August 15, 2006
Needle-free injectors for medical use - Requirements and test methods
This standard applies safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and...
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other...
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