标准摘要
[中文适用范围]: 本文件规定了可重复使用的锐器容器的要求,该容器旨在容纳具有或不具有锐器保护功能的潜在危险锐器医疗废物,例如手术刀刀片、套管针、皮下注射针头和注射器。 本文件适用于由制造商完整提供的锐器容器以及作为供用户组装的组件提供的锐器容器。 它不适用于一次性锐器容器(此类容器请参阅 ISO 23907-1)。 该文件包括用户安全、寿命模拟、清洁和净化、微生物验证、质量监控和性能测试的设计功能。 [外文原描述]: 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.
英文名称Sharps injury protection — Requirements and test methods — Part 2: Reusable sharps containers