<p>This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).</p>
<p>General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:</p>
<p>a) medicinal product preparation (e.g. reconstitution);</p>
<p>b) needle preparation;</p>
<p>c) needle hiding;</p>
<p>d) priming;</p>
<p>e) dose setting;</p>
<p>f) needle insertion;</p>
<p>g) injection depth control;</p>
<p>h) injection of the medicinal product;</p>
<p>i) recording of device functions;</p>
<p>NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto).</p>
<p>j) disabling the NIS-AUTO;</p>
<p>k) needle retraction;</p>
<p>l) needle shielding;</p>
<p>m) needle removal.</p>
<p>All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.</p>
Registration number (WIID)
76627
Scope
<p>This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).</p>
<p>General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:</p>
<p>a) medicinal product preparation (e.g. reconstitution);</p>
<p>b) needle preparation;</p>
<p>c) needle hiding;</p>
<p>d) priming;</p>
<p>e) dose setting;</p>
<p>f) needle insertion;</p>
<p>g) injection depth control;</p>
<p>h) injection of the medicinal product;</p>
<p>i) recording of device functions;</p>
<p>NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto).</p>
<p>j) disabling the NIS-AUTO;</p>
<p>k) needle retraction;</p>
<p>l) needle shielding;</p>
<p>m) needle removal.</p>
<p>All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.</p>
