In the ISO 21649 standard developed by the International Standards Organization (ISO), the properties and test methods of needle-free injectors for medical use are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 21649 Needle-free injectors for medical use - Properties and test methods.
This standard describes the safety, performance and testing requirements for disposable and multi-use needle-free injection systems designed for human use in clinics, hospitals and other healthcare facilities and for personal use by patients.
The dose chamber of the injection system is generally for single use and needs to be replaced after a single use or a limited number of uses. This dose chamber is sometimes separated from the injection system and is often referred to as cartridge, ampoule, syringe, capsule, or disc. In contrast, the dose chamber is designed to last for the desired life of the injection system and is in the form of a permanent interior chamber.
The ISO 21649 standard covers needle-free injector systems that generally aim to deliver medical products to people. Such systems have a wide variation in design. Therefore, this standard was developed more horizontally rather than vertically. On the other hand, such standards avoid covering more than essential aspects of the safety and performance of needle-free injector devices in humans.
Dose sections designed for different needleless injection systems have the advantage of being intentionally interchangeable, or they carry the potential risks of accidental modification. Therefore, these standards do not establish design specifications for the uniform size, shape, and interface of such dose sections.
Our organization also provides testing services for needle-free injectors for ISO 21649 medical use within the scope of laboratory services.
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