医疗器械 - 非电驱动便携式输液装置

[中文适用范围]： 本文件规定了非电动便携式输液设备（以下称为“设备”）的基本要求和相关测试方法。它适用于设计用于连续（固定或可调）流量和/或推注神经轴和血管内或皮下应用的设备。注：神经轴应用的部位包括脊柱、鞘内或蛛网膜下腔、脑室和硬膜外、硬膜外或硬膜周围。神经轴应用麻醉剂可区域施用，影响身体的大部分，例如肢体，包括神经丛阻滞，例如鳃丛阻滞或单神经阻滞。神经轴应用程序包括向伤口持续输注局部麻醉剂。这些设备可用于医疗保健和非医疗保健环境。它们可以由医疗保健专业人员或预期患者应用或管理。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预期患者在使用前填充。本文件不适用于： — IEC 60601-2-24 涵盖的电动或电动控制输液泵， — ISO 11608 系列涵盖的用于单个患者使用的、用于输送离散体积（推注）药品的设备， — 植入式设备， — 肠内设备， — 透皮给药设备，以及 — 输液能量不是由设备提供或通过患者主动干预提供的设备（例如仅由重力驱动的设备）。 [外文原描述]： 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. This document does not apply to — electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24, — devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series, — implantable devices, — enteral devices, — transdermal delivery devices, and — devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).