产品介绍:
制氧机,是一种氧气收集器,通过压缩机吸抽空气到分子筛,机器中的分子筛具有吸附性能,通过物理原理,以大排量无油压缩机为动力,把空气中的氮气与氧气进行分离,*终得到高浓度的氧气。产品一般有压缩机,分子筛,氧气浓度感应/报警模块,显示模块等组成,同时也可配氧气鼻管,面罩等附件。
510K代码信息:
分类名: Generator, Oxygen, Portable per 21 CFR 8 6 8 .5 4 40
审核部门: Anaesthesiology
产品代码: CAW
510K申请关注点:
*大浓度一般不少于5L,氧气浓度90±3%以上;
产品气路尾气性能要满足ISO18562 相关标准;
如果产品配了湿化器功能,气路带水分,气路尾气需要额外评估沥出物的标准ISO18562-4;
产品应提供低电量,低浓度,断电,压缩机高温等警报功能,并且要符合IEC60601-1-8。
测试标准:
电气安全:Electrical safety and performance test according to ANSI AAMI ES60601-1:2005/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD)
电气安全:IEC60601-1-8 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
电磁兼容:Electromagnetic compatibility test according to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
生物安全:Biocompatibility test according to ISO 10993-5:2009 and ISO 10993-10:2010
气路生物兼容:ISO 18562-2, ISO 18562-3, ISO 1856-4
产品专业标准:ISO 80601-2-69:2020 Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
家用环境评估:IEC60601-1-11:2015