标准摘要
[中文适用范围]： 本文件规定了评估包含一次性尖端器械（用于给药和/或采集血液或其他体液以及/或药物）设备的锐器损伤保护机制（SIPMs）的要求和试验方法。本文件涵盖的锐器损伤保护机制可以是集成到设备中的，也可以在使用前与设备组装。 测试的目的是确认在预期使用期结束后（包括安全处置或回收路径，如果法律要求或制造商决定），减少被污染锐器意外刺伤风险。本文件不涵盖以下内容：利用钝头设计的药物加载和传输装置；侵入性产品，其预期用途是访问小空间（特别是耳、鼻、喉）以执行眼科程序，因为发现这些SIPMs会严重影响设备的可用性并增加患者的使用风险。 本文件不涵盖用于手术的实心针（例如缝合针）。 [外文原描述]： This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances. The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use. The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision. This document does not cover — devices for medication loading and transfer, utilizing a blunt tip design, or — invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device. This document does not cover solid-core needles used for surgery (e.g. suture needles).
英文名称Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods