Key points analysis for GB 9706.255-2022 revision / 医疗卫生装备

ABSTRACT

The background and scope of the revision of GB 9706.255-2022"Medical Electrical Equipment-Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors"were introduced.The differences between GB 9706.255-2022 and YY 0601-2009"Medical electrical equipment particular requirements for basic safety and essential performance of respiratory gas monitors"were summarized.The key points of the revision of GB 9706.255-2022 were interpreted in terms of basic performance,marking signs and documents,protection level,calibration/nulling,rough handling,functional connectivity and usability.References were provided for manufacturers and inspection technicians to correctly understand GB 9706.255-2022.[Chinese Medical Equipment Journal,2023,44(11):79-82]