Abstract：This paper analyzed the risk triggered by the sound pressure level of medical electrical equipment associated with auditory alarming signal, background noise, adjustable and inactive status and provided the corresponding control measures.
吴少海，邓沙. 医用电气设备听觉报警信号声压级的风险分析与控制[J]. 中国医疗设备, 2015, 30(11): 62-64.
WU Shao-hai, DENG Sha. Risk Analysis and Control of Auditory Alarming Signal Sound Pressure Level for Medical Equipment. China Medical Devices, 2015, 30(11): 62-64.
IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirement for basic safety and essential performance[S].
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YY0316,医疗器械 风险管理对医疗器械的应用[S].
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IEC 60601-1-8:2012,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[S].
IEC 60601-1-8:2012,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[S].
IEC 60601-1-8:2012,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[S].
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IEC 60601-1-8:2003,Medical electrical equipment-Part 1-8:General requirements for safety-Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems[S].
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IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirement for basic safety and essential performance[S].
IEC 60601-1-8:2003,Medical electrical equipment-Part 1-8:General requirements for safety-Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems[S].
[5]
IEC 60601-1-8:2003,Medical electrical equipment-Part 1-8:General requirements for safety-Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems[S].
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ISO 3744:2010,Acoustics-Determination of sound power levels and sound energy levels of noise sources using sound pressure-Engineering methods for an essentially free field over a reflecting plane[S].
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ISO 3744:2010,Acoustics-Determination of sound power levels and sound energy levels of noise sources using sound pressure-Engineering methods for an essentially free field over a reflecting plane[S].
[10]
ISO 3744:2010,Acoustics-Determination of sound power levels and sound energy levels of noise sources using sound pressure-Engineering methods for an essentially free field over a reflecting plane[S].
