本文件规定了用于存放潜在危险锋利物的可重复使用锋利物容器的要求，无论是否带有锋利物保护功能，例如手术刀刀片、套管针、皮下注射针和注射器。 本文件适用于由制造商完整提供的锋利物容器，以及作为拟由用户组装的部件提供的容器。 不适用于一次性锋利物容器（此类容器参考ISO 23907-1）。 本文件包括用户安全、寿命模拟、清洁和去污、微生物验证、质量监控和性能测试的设计功能。

This document specifies requirements for reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes. This document is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user. It is not applicable to single use sharps containers (refer to ISO 23907-1 for such containers). This document includes design functionality for user safety, lifespan simulation, cleaning and decontamination, microbiological validation, quality monitoring and performance testing.