SS-EN-ISO-21649 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

SS-EN-ISO-21649 - 2009 EDITION - CURRENT
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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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

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Designation Name

SS-EN ISO 21649:2009

Revision Level

2009 EDITION

Status

Current

Publication Date

Sept. 28, 2009

Language(s)

English

Page Count

48

International Equivalent

EN ISO 21649:2009(IDT); ISO 21649:2006(IDT)