ISO 16571:2024 医疗器械产生的羽流的疏散系统

标准编号：ISO 16571:2024

中文名称：医疗器械产生的羽流的疏散系统

英文名称：Systems for evacuation of plume generated by medical devices

发布日期：2024-03

标准范围

？本文件规定了用于排出医疗器械产生的烟羽的系统和设备的要求和指南。？本文件适用于所有类型的羽流排空系统(PESs)，包括A）？便携；b）？移动；c）？固定式，包括专用中央管道；d）？PESs集成到其他设备中；e）？内窥镜手术（如微创、腹腔镜）的PESs本文件适用于所有使用PESs的医疗机构，包括但不限于A）？手术设施；b）？医疗办公室；c）？美容治疗设施；d）？医学教学设施；e）？牙科诊所；(f)？兽医设施。本文件就PESs的以下方面提供指导:A）？重要性；b）？采购；c）？设计；d）？制造；e）？文件；(f)？功能；(g)？性能；(h)？安装；i)？调试；j）？测试；k）？培训；l）？使用；m）？风险评估；n）？维修；o）？维护。本文件不适用于以下情况:A）？ISO涵盖的麻醉气体清除系统（AGSSs）？7396-2;b）？ISO涵盖的医用真空系统？7396-1;c）？供暖、通风和空调（HVAC）系统；d）？空气污染以外的激光安全方面；和e）？电外科、电灼术和机械外科工具的其他方面，但此类设备因与组织或材料相互作用而产生的空气污染除外。

 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 (PESs), including

a)       portable;

b)       mobile;

c)        stationary, including dedicated central pipelines;

d)       PESs integrated into other equipment;

e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)

This document applies to all healthcare facilities where PESs 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 PESs:

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.

标准预览图