ISO 21649:2023
医用非针头式注射器.要求和试验方法
Needle-free injection systems for medical use — Requirements and test methods
- 标准号
- ISO 21649:2023
- 发布
- 2023年
- 发布单位
- 国际标准化组织
- 当前最新
- ISO 21649:2023
- 引用标准
- IEC 60068-2-27 IEC 60068-2-31 IEC 60068-2-64 IEC 60529 IEC 61000-4-2:2008 IEC 61000-4-3:2020 IEC 61672-1 IEC 62366-1 ISO 10993 (all parts) ISO 11201 ISO 11202 ISO 11204 ISO 14155 ISO 14971:2019 ISO 7886-3:2020
- 适用范围
- This document applies to safety and performance and testing requirements for single-use and multiple- use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS 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 can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: — involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); — generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); — deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); — apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); — infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.