标准摘要
[中文适用范围]： 本文件规定了包含电子设备（带或不带软件）的基于针的注射系统（NIS）的要求和测试方法（NIS-E）。 包含电子设备的基于针的注射系统可以是一次性的或可重复使用的，并且可以在有或没有与其他设备的电气/导电连接的情况下进行操作。 该系统旨在通过自我管理或由另一操作员（例如护理人员或医疗保健提供者）管理来向患者输送药物。 本文档适用于根据 NIS/NIS-E 预期用途物理连接到 NIS 或 NIS-E 的电子配件。 本文件还适用于根据 NIS/NIS-E 预期用途与 NIS 或 NIS-E 进行电气/导电连接的电子配件。 本文档未指定可编程 NIS-E 中软件的要求。 注意 IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020，第 14 条涉及软件生命周期过程。 本文件没有规定网络安全要求。 [外文原描述]： This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). 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). 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. 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. This document does not specify requirements for software in programmable NIS-E. NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes. This document does not specify requirements for cybersecurity.
英文名称Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics