UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

SNV - SN EN ISO 21649

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

active, Most Current
Organization: SNV
Publication Date: 1 March 2010
Status: active
Page Count: 46
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

SN EN ISO 21649
March 1, 2010
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...
September 1, 2006
Needle-free injectors for medical use – Requirements and test methods
A description is not available for this item.

References

Advertisement