<p>This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).</p>
<p>The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).</p>
<p>This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use.</p>
<p>This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use.</p>
<p>This document does not specify requirements for software in programmable NIS-E.</p>
<p>NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.</p>
<p>This document does not specify requirements for cybersecurity.</p>
Registration number (WIID)
72450
Scope
<p>This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).</p>
<p>The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).</p>
<p>This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use.</p>
<p>This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use.</p>
<p>This document does not specify requirements for software in programmable NIS-E.</p>
<p>NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.</p>
<p>This document does not specify requirements for cybersecurity.</p>
