- HOME >> SOLUTIONS >> By Standard >> ISO Test Standards
ISO 11608
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)
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)
Relate Products
