标准摘要
[中文适用范围]： 本文件规定了用于疏散由医疗设备产生的烟雾的系统和设备的要求和指南。本文件适用于所有类型的烟雾疏散系统（PESs），包括但不限于a) 移动式；b) 可移动式；c) 固定式，包括专用中央管道系统；d) 集成在其他设备中的PESs；e) 内窥镜程序用PESs（例如，微创、腹腔镜）。本文件适用于所有使用PESs的医疗卫生设施，包括但不限于a) 手术室；b) 医疗诊所；c) 美容治疗设施；d) 医学教学设施；e) 牙科诊所；f) 兽医设施。本文件提供了关于PESs以下方面的指导：a) 重要性；b) 购买；c) 设计；d) 制造；e) 文件；f) 功能；g) 性能；h) 安装；i) 启动；j) 测试；k) 培训；l) 使用；m) 风险评估；n) 服务；o) 维护。本文件不适用于以下内容：a) 被ISO 7396-2涵盖的麻醉气体清除系统（AGSSs）；b) 被ISO 7396-1涵盖的医疗真空系统；c) 加热、通风和空调（HVAC）系统；d) 激光安全方面的内容，除空中污染外；e) 电外科、电凝和其他机械手术工具方面的内容，除这些设备与组织或材料相互作用产生的空中污染物外。 [外文原描述]： This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices . This document applies to all types of plume evacuation systems ( PES s), including a) portable ; b) mobile ; c) stationary, including dedicated central pipelines; d) PES s integrated into other equipment; e) PES s for endoscopic procedures (e.g., minimally invasive, laparoscopic) This document applies to all healthcare facilities where PES s are used, including, but not limited to a) surgical facilities; b) medical offices; c) cosmetic treatment facilities; d) medical teaching facilities; e) dental clinics; f) veterinary facilities. This document provides guidance on the following aspects of PES s: a) importance; b) purchasing; c) design; d) manufacture; e) documentation; f) function; g) performance; h) installation; i) commissioning; j) testing; k) training; l) use; m) risk assessment; n) servicing; o) maintenance. This document does not apply to the following: a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2; b) medical vacuum systems which are covered in ISO 7396-1; c) heating, ventilation, and air-conditioning (HVAC) systems; d) aspects of laser safety other than airborne contamination; and e) aspects of electrosurgery , electrocautery , and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
英文名称Systems for evacuation of plume generated by medical devices