国产制氧机出口FDA要求

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