本文件规定了拟用于轴向应用的导管系统的一般要求和试验方法。 本文件规定了制造商提供的预期性能、设计属性、材料、设计评估、制造、灭菌、包装和信息的要求，以及证明符合这些要求的试验。 用于神经轴应用的导管旨在将药物直接注入神经轴部位，提供伤口浸润镇痛和其他区域镇痛程序，或出于治疗或诊断目的监测或清除神经轴部位的液体。 注1:神经轴的应用部位包括脊柱、鞘内或蛛网膜下腔以及硬膜外、硬膜外或硬膜外腔（所提及的应用仅为示例，并非详尽清单）。 在神经轴应用中，麻醉剂/镇痛剂可局部施用，影响身体的大部分，如肢体，并包括神经丛阻滞，如臂丛阻滞或单神经阻滞。神经轴应用程序包括用局部麻醉剂持续灌注伤口。 注2:皮下注射局部麻醉/镇痛和全身注射麻醉剂不被视为神经轴应用。 本文件适用于以下类型的设备: -脊髓/硬膜外导管系统； -脊髓/硬膜外导管系统； -周围神经阻滞导管系统； -伤口输液导管系统（也称为手术部位持续镇痛导管）。 本文件不适用于: -通过这些导管系统输送药物的泵和其他设备； -导管一般用于向体内注入物质，这些物质不是直接与神经系统相互作用，而是对神经系统产生间接影响（例如套管针）； -除Neuraxic外的任何其他应用的引流导管。

This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications. This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements. Catheters for neuraxial applications are intended to administer medications directly into neuraxial sites, to deliver wound infiltration analgesia and to other regional analgesia procedures or to monitor or remove fluids from neuraxial sites for therapeutic or diagnostic purposes. NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space and the epi-, extra-, or peri-dural space (applications mentioned are just examples and not an exhaustive list). In neuraxial application, anaesthetics/analgesics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the brachial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. NOTE 2 Local anaesthesia/analgesia injected hypodermically and systemic injection of anaesthetics are not considered neuraxial applications. This document is applicable to the following types of devices: — spinal/epidural catheter systems; — spinal/epidural port catheter systems; — peripheral nerve block catheter systems; — wound infusion catheter systems (also known as catheters for Surgical Site Continuous Analgesia). This document is not applicable to: — pumps and other devices intended to deliver medications through these catheter systems; — catheters generically intended to administer substances into the body which are not intended to interact directly with the nervous system, but which have an indirect effect on nervous system (e.g. cannula needles); — drainage catheters for any other application than neuraxial.