ISO 165712024Amd 12026 医疗器械产生的烟羽排空系统 修正案1标准立项发展报告.docx

医疗器械产生的烟羽排空系统修正案1标准立项发展报告

StandardizationDevelopmentReport:Amendment1toSystemsforEvacuationofPlumeGeneratedbyMedicalDevices

摘要

关键词：医疗器械；烟羽排空系统；ISO标准；修正案；手术安全；职业健康；标准化

Abstract

Withthewidespreadapplicationofminimallyinvasivesurgeryandenergy-basedmedicaldevicesinclinicalpractice,thepotentialhealthhazardsposedbysurgicalplumetohealthcareworkersandpatientshavedrawnincreasinginternationalattention.Surgicalplumecontainstoxicchemicalsubstances,activemicroorganisms,viralparticles,andnano-sizedparticulates,andlong-termexposuremayleadtoo