scope:

This document specifies requirements and test methods for needle-based injection systems with automated functions (NIS-AUTO), including but not limited to: a) medicinal product preparation (e.g. reconstitution); b) needle preparation; c) needle hiding; d) priming; e) dose setting; f) needle insertion; g) injection depth control; h) injection of the medicinal product; i) recording; j) disabling the NIS-AUTO; k) needle retraction; l) needle shielding; m) needle removal. This document does not cover remote communication from the NIS-AUTO. Automated features not included in the list above shall be specified and tested in accordance with the principles of this document. All references to "function" in this document are by definition to be construed as automated functions (see 3.2). This document does not apply to these functions if they are performed manually by the user.