ISO 21649:2006
Needle-free injectors for medical use - Requirements and test methods

Standard No.

ISO 21649:2006

Release Date

2006

Published By

International Organization for Standardization (ISO)

Status

Be replaced 2023-01

Replace By

ISO 21649:2023

Latest

ISO 21649:2023

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.

ISO 21649:2006 Referenced Document

• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 11201:1995 Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Engineering method in an essentially free field over a reflecting plane
• ISO 11202:1995 Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Survey method in situ
• ISO 3207:1975 Statistical interpretation of data; Determination of a statistical tolerance interval
• ISO 3746:1995 Acoustics - Determination of sound power levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane

ISO 21649:2006 history

• 2023 ISO 21649:2023 Needle-free injection systems for medical use — Requirements and test methods
• 2006 ISO 21649:2006 Needle-free injectors for medical use - Requirements and test methods