ISO 7886-1 测试无菌注射器

 ISO 7886 

stethoscope icon

 

Hypodermic syringes are critical medical devices that allow medication to be delivered safely and efficiently at very precise doses. Because of their importance, it is crucial that hypodermic syringes perform as expected at all times. A leaking syringe can result in improper medication dosing and wastage and cause procedures to be delayed. The force required to expel liquid from the syringe must also be small enough to ensure that any medical professional can perform the task without resistance. 

ISO 7886-1 Annexes and Measurements

 

The ISO 7886-1 standard regulates the mechanical properties of hypodermic syringes and outlines the specifications for single use hypodermic syringes. It also includes information related to the design, manufacture, and functionality of the devices, while the annexes of the standard describe the standard operating procedure for testing these devices. Whereas ISO 7886-1:1993 discusses mechanical testing in annex G, the newer version of the standard, ISO 7886-1:2017 discusses it in annexes D and E.

Annex D measures the quality of the plunger stopper seal by simultaneously applying a perpendicular force to the syringe barrel and maintaining a constant compressive force on the syringe piston. A visual check is performed to ensure that no liquid escapes past the plunger stopper seal. This annex is less commonly tested than Annex E, which measures the forces needed to operate the syringe plunger with water in the barrel. The force profile typically displays an initial peak force known as the break loose force, and an average force of the remaining plunger travel, known as the glide force. This test also requires the recording of maximum force during plunger travel excluding the break loose force.

Testing System

ISO 7886-1 testing is performed on a single column universal testing system such as those found in Instron's 3400 or 6800 Series. A 2870-003 syringe fixture is required and is designed for this method specifically. Because the forces involved are relatively small, a 100 N or 50 N load cell is preferred. A biotray may also be helpful since there is potential for spillage from the reservoir onto the test system frame.




ISO 7886-1 Test Setup
1) 3300 Series Universal Testing System
2) 2530 Series Load Cell
3) 2870-003 Syringe Test Fixture

 

ISO 7886 test setup
Recent Changes to the Standard 

ISO 7886-1:2017 introduced many changes which require altering the test procedure and the results. The previous version of the standard required the expulsion and aspiration of the syringe while the newest version only requires expulsion similar to a typical break loose and glide force test. The fixturing has also changed, with the old method requiring the tubing from the syringe to be affixed to the reservoir. The new version requires a specific gauge and length needle to be attached to the end of the tube and then placed in the reservoir, resulting more repeatable results. To review the requirements in full, read the standard. To learn more about drug delivery device and container testing, click here


Related Content

6800 系列高级测试系统宣传册

Instron 6800 系列通用测试系统可提供无与伦比的准确性和可靠性。6800 系列以专利申请中的操作员保障系统架构为依托,架构采用全新的 Smart-Close 空气套件并具有碰撞缓解功能,使得材料测试比以往任何时候都更简单、更智能、更安全。

3400 系列 - 经济适用的测试解决方案

Instron 3400 系列通用测试系统用于拉伸、压缩、弯曲和其他材料性能测试。

Bluehill Universal 宣传册

Bluehill Universal 软件从头开始构建,旨在提供触摸互动和直观的用户体验。使用诸如预装测试方法、几秒钟内快速测试、增强的数据导出以及 Instron Connect(一种全新功能,可提供与服务的直接通信联系)等功能,发现更简单、更智能的测试。 Bluehill 2 和 Bluehill 3 等以前版本软件的用户可以轻松升级到最新版本的 Bluehill。

 针对 ISO 7886-1 标准的 2870-003 注射器测试工装

Instron® 注射器测试工装设计用于满足无菌、一次性皮下注射器的 ISO 7886-1:2017 附录 E 和 ISO 7886-1:1993 附录 G 的测试要求。