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Fluid delivery performance testing for infusion pumps 输液泵的流体输送性能测试
发布日期: 2021-10-15
本文件定义了液体输送性能测试方法,涵盖了输液泵的全部使用条件,以提供泵在使用中的性能的临床相关数据。本文件适用于所有指定输送模式的注射器泵、容器泵和容积式输液泵,包括肠内、患者自控镇痛(PCA)或硬膜外和规定的输液源(例如,从注射器抽取的容积式输液泵)。本文件不确定输液泵性能的临床可接受性标准,不提供试验方法验证指南,也不涉及测量不确定度。
This document defines fluid delivery performance test methods that cover the full range of use conditions of an infusion pump in order to provide clinically relevant data of how the pump will perform in use. This document is applicable to syringe pumps, container pumps, and volumetric infusion pumps for all indicated delivery modes including enteral, patient controlled analgesia (PCA), or epidural and prescribed infusate sources (e.g., volumetric infusion pump drawing from a syringe). This document does not establish criteria for the clinical acceptability of infusion pump performance, provide guidance for test method validation, or address uncertainty of measurement.
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