YY/T 0907-2013 in English

本标准适用于在临床和相关医疗环境下的患者个人使用的一次或多次使用的无针注射器的安全、性能和试验要求。

Scope

This standard applies to the safety, performance and testing requirements for single- or multiple-use needleless syringes for personal use by patients in clinical and related healthcare settings. The dosing chamber of a syringe 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 often referred to as a "cartridge", "ampule", "syringe", "capsule" or "disc". Conversely, the dose chamber can also be a permanent lumen whose performance remains effective during the expiry date. What does not apply to this standard is the method of drug administration:
　——puncture 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) ;
　——Produces aerosols, droplets, powders or other forms for inhalation, blowing, nasal or oral deposition (such as sprays, inhalers, microdevices);
　——Deposits on skin or mucous membrane surfaces, liquids, powders or other Substances passively diffused or ingested by the body (such as transdermal absorption patches, droplets);
　——Applied to acoustic energy or electromagnetic energy (such as ultrasound or iontophoresis devices);
　——Applied to accumulation or measurement into or through artificial A drug infusion system with tubing, catheters, and/or needles that themselves enter the body.