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ISO 21649:2006

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ISO 21649:2006

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

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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.

Author ISO/TC 84 Devices for administration of medicinal products and catheters
Editor ISO
Document type Standard
Format Paper
Edition 1
ICS 11.040.20 : Transfusion, infusion and injection equipment
Number of pages 32
Weight(kg.) 0.1544
Year 2006
Country Switzerland