本文件规定了非电动汽车的基本要求和相关试验方法 便携式输液器，后来被称为“设备”。 适用于设计用于连续（固定或可调）流量和/或团注的装置 以及血管内或皮下应用。 注:神经轴的应用部位包括脊柱、鞘内或蛛网膜下腔、脑室 大脑和硬膜外、硬膜外或硬膜外空间。可以使用神经轴应用麻醉剂 局部性的，影响身体的大部分，如四肢，包括神经丛阻滞，如鳃裂 神经丛阻滞或单神经阻滞。神经轴应用程序包括持续灌注伤口 用局部麻醉剂。 这些设备可用于医疗和非医疗环境。它们可以应用或 由医疗保健专业人员或预期患者管理。 这些设备可以由制造商预先填充，也可以由医疗保健专业人员或专业人员在使用前填充 目标患者。交叉引用:ISO 80369-1ISO 80369-7ISO 80369-6ISO 15223-1ISO 10993-1EN 1041EN 556-1ISO 554IEC 60601-2-24ISO 17665-1ISO 11137（所有部分）ISO 11607-1ISO 11135ISO 11608（所有部分）ISO 14937ISO 10555-1EN 13868ANSI/AAMI ST67ISO 11139:2018购买本文件时提供的所有当前修订版。

This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called "device". It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications. NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient. These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.Cross References:ISO 80369-1ISO 80369-7ISO 80369-6ISO 15223-1ISO 10993-1EN 1041EN 556-1ISO 554IEC 60601-2-24ISO 17665-1ISO 11137 (all parts)ISO 11607-1ISO 11135ISO 11608 (all parts)ISO 14937ISO 10555-1EN 13868ANSI/AAMI ST67ISO 11139:2018All current amendments available at time of purchase are included with the purchase of this document.