GB 9706.237-2020
ActiveMedical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
医用电气设备 第2-37部分：超声诊断和监护设备的基本安全和基本性能专用要求
Application Summary AI generated
This standard specifies the particular safety and performance requirements for ultrasonic diagnostic and monitoring equipment, such as ultrasound scanners and fetal monitors, used in medical environments. It is applied to ensure these devices meet essential safety criteria, including limits on acoustic output to prevent tissue heating or cavitation, and to guarantee accurate imaging or monitoring functions. The standard is mandatory for manufacturers and healthcare facilities in China to certify compliance during product development, type testing, and regulatory approval.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.