DIN EN ISO 21649:2006
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006); German version EN ISO 21649:2006

Standard No.

DIN EN ISO 21649:2006

Release Date

2006

Published By

German Institute for Standardization

Status

Be replaced 2010-01

Replace By

DIN EN ISO 21649:2010

Latest

DIN EN ISO 21649:2023-06

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.

DIN EN ISO 21649:2006 history

• 2023 DIN EN ISO 21649:2023-06 Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023); German version EN ISO 21649:2023
• 2023 DIN EN ISO 21649:2023 Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
• 1970 DIN EN ISO 21649 E:2022-03 Requirements and test methods for non-needle syringes for medical use (draft)
• 2010 DIN EN ISO 21649:2010 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006); German version EN ISO 21649:2009
• 2006 DIN EN ISO 21649:2006 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006); German version EN ISO 21649:2006