This standard specifies the definition, requirements, test methods and inspection rules of B-type ultrasonic diagnostic equipment. This standard applies to B-type ultrasonic diagnostic equipment with a nominal frequency in the range of 1.5MHz-15MHz, including the two-dimensional gray-scale imaging part of color Doppler ultrasonic diagnostic equipment. This standard does not apply to ophthalmology professional ultrasonic diagnostic equipment and vascular ultrasonic diagnostic equipment.
GB 10152-2009 Referenced Document
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*, 2020-04-09 Update
GB 9706.15 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems
GB 9706.9 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
YY/T 0108-2008 Testing methods for M-mode of ultrasonic diagnostic equipment
YY/T 1142-2003 Methods of measuring the frequency of medical diagnostic and monitoring ultrasonic equipment
GB 10152-2009 history
2009GB 10152-2009 B mode ultrasonic diagnostic equipment
1997GB 10152-1997 B mode ultrasonic diagnostic equipment