用于神经轴应用的导管系统 - 无菌和一次性导管及附件

[中文适用范围]： 本文件规定了用于椎管内应用的导管系统的一般要求和测试方法。 本文件规定了对预期性能、设计属性、材料、设计评估、制造、灭菌、包装和制造商提供的信息的要求，以及证明符合这些要求的测试。 用于椎管内应用的导管旨在将药物直接施用到椎管部位，以提供伤口浸润镇痛和其他区域镇痛程序，或者为了治疗或诊断目的而监测或移除椎管部位的液体。 注 1：椎管内应用的部位包括脊柱、鞘内或蛛网膜下腔以及硬膜外、硬膜外或硬膜周围空间（所提及的应用仅是示例，并非详尽列表）。 在椎管内应用中，可以局部施用麻醉剂/镇痛剂，影响身体的大部分，例如肢体，并且包括神经丛阻滞，例如臂丛神经阻滞或单神经阻滞。 椎管内应用程序包括向伤口连续输注局部麻醉剂。 注 2：皮下注射局部麻醉/镇痛和全身注射麻醉剂不被视为椎管内应用。 本文件适用于以下类型的装置： ——脊柱/硬膜外导管系统； ——脊髓/硬膜外端口导管系统； ——周围神经阻滞导管系统； ——伤口输液导管系统（也称为手术部位连续镇痛导管）。 本文件不适用于： ——旨在通过这些导管系统输送药物的泵和其他装置； ——一般用于将物质注入体内的导管，这些物质不直接与神经系统相互作用，但对神经系统有间接影响（例如套管针）； ——用于椎管外任何其他应用的引流导管。 [外文原描述]： 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.