ISO 11608-1:2022 NEEDLE-BASED INJECTION SYSTEMS

Mechanical Testing of Autoinjectors

ISO 11608 is a testing standard that describes the functional requirements for needle-based injection systems (NIS). It is critical that biomedical manufacturers perform thorough testing of these devices during development and production, due to their importance in delivering medications. As possibly the most extreme example, autoinjectors deliver immediate lifesaving intervention in the case of anaphylaxis, and cannot afford to fail.

ISO 11608 aims to ensure that the device reliably performs the minimum activation and operation steps to meet safety requirements and to be reliably operated by various users. This typically includes the following evaluations:

Cap removal/Priming Force

Activation Force

Injection Time

Dose Accuracy (Referencing ISO 11608-1)

Effective Needle Length During Injection

Needle Shield Override (If using passive safety device)

Confirmation of Operation (Automated functions require either visual or audible indication for the user that they have completed)

Mechanical Testing System

Kason has developed a single column universal testing system with an autoinjector test fixture to provide repeatable and reliable results. Utilizing a single system to sequentially test all the parameters outlined in ISO 11608-5 provides more consistent test results and simplifies data collection and analysis.