GB 10152-2009
B mode ultrasonic diagnostic equipment (English Version)

Standard No.
GB 10152-2009
Language
Chinese, Available in English version
Release Date
2009
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest
GB 10152-2009
Replace
GB 10152-1997
Scope
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

  • 2009 GB 10152-2009 B mode ultrasonic diagnostic equipment
  • 1997 GB 10152-1997 B mode ultrasonic diagnostic equipment
  • 0000 GB 10153-1988
B mode ultrasonic diagnostic equipment



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