YY/T 0907-2013 Needle-free injectors for medical use—Requirements and test methods

Scope

This standard applies to the safety, performance, and testing requirements of needle-free injectors for single or multiple use by patients in clinical and related medical environments.
The dose chamber of the injector is usually disposable and is replaced after a single use or a limited number of uses. Sometimes, it is separate from the injection mechanism and is commonly referred to as a "cartridge", "ampoule", "syringe", "capsule", or "disc". Conversely, the dose chamber can also be a permanent inner chamber, the performance of which can remain effective within its expiration date.
This standard does not apply to the methods of drug administration:
——[ZK（]The penetration of a part of the needle-free injection device itself into or through the skin or mucous membrane (such as needles, tips, microneedles, implantable slow-release drug devices); [ZK）]
——[ZK（]The generation of aerosols, droplets, powders, or other forms for inhalation, insufflation, or nasal or oral deposition (such as sprays, inhalers, or micro-devices); [ZK）]
——[ZK（]The passive diffusion or ingestion by the human body of liquids, powders, or other substances deposited on the surface of the skin or mucous membrane (such as transdermal absorption patches, droplets); [ZK）]
——Applications of acoustic or electromagnetic energy (such as ultrasound or iontophoresis devices);
——[ZK（]Applications of infusion systems for accumulating or measuring drugs entering or passing through artificial tubes, catheters, and/or needles entering the human body themselves. [ZK）]

Development Information

Superseded by the following standards

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