Experiences in Testing Oxygen-Carrying Medical Electrical Equipment Against the Requirements of IEC 60601-1:2020 Subclause 11.2.2.1 b)
SourceIt is crucial to analyze and test oxygen-carrying medical electrical (ME) equipment such as ventilators, respirators, and CPAPs for fire risks in oxygen-rich environments. This paper discusses the failure modes and ignition sources associated with such equipment. Drawing on over three decades of experience in investigating oxygen-related fires and testing medical devices, the authors provide guidance for manufacturers on mitigating these fire risks by ensuring adherence to international safety standards and exploring various analysis and testing pathways, from power limitations to evaluations of fire consequences. The study aims to guide manufacturers in understanding the oxygen fire hazards in their oxygen-carrying ME equipment and then meeting the specific requirements of IEC 60601-1:2020 Part 1-11: General Requirements for Basic Safety and Essential Performance, Subclause 11.2.2.1 b) for “ME Equipment and ME Systems Used in Conjunction with Oxygen Rich Environments.”