标准编号：ISO 11608-4:2022
中文名称：医用针头注射系统 要求和试验方法 第4部分：含电子元件的针式注射
英文名称：Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
发布日期：2022-04
标准范围
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.
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