EN ISO 21649:2009

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

Publication date:   Sep 16, 2010

General information

99.60 Withdrawal effective   Feb 8, 2023

CEN

CEN/BT

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 21649:2006 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 21649:2006

NOW

WITHDRAWN
EN ISO 21649:2009
99.60 Withdrawal effective
Feb 8, 2023

REVISED BY

PUBLISHED
EN ISO 21649:2023

Relations

Adopted from ISO 21649:2006 IDENTICAL