国产制氧机出海美国必看

办理CE认证小乐

产品与基本原理

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，最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

预期用途

The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.

510(k)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
  
  

510(k)申请关注点

• 最大浓度一般不少于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
  
  

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办理CE认证小乐

46070809 发表于 2023-6-13 13:20
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