GB 9706.9-2008
Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment (English Version)

Standard No.
GB 9706.9-2008
Language
Chinese, Available in English version
Release Date
2008
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status
 2023-05
Replace By
GB 9706.237-2020
Latest
GB 9706.237-2020
Replace
GB 9706.9-1997
Scope
Addition: This specific standard specifies the specific safety requirements for ultrasonic diagnostic equipment defined in 2.1.145. Ultrasound therapy equipment is not covered by this standard; however, equipment that uses ultrasound to image human tissue in conjunction with a therapy device is included.

GB 9706.9-2008 Referenced Document

  • GB 4208-1993 Degrees of protection provided by enclosure (IP code)
  • GB/T 16540-1996 Acoustics--Measurement and characterisation of ultrasonic fields in the frequency range 0.5MHz to 15MHz--Hydrophone method
  • GB/T 16846-2008 Requirement for the declaration of acoustic output of medical diagnostic ultrasonic equipment
  • IEC 61161:2006 Ultrasonics - Power measurement - Radiation force balances and performance requirements
  • YY/T 0316-2003 Medical devices-Application of risk management to medical devices

GB 9706.9-2008 history

  • 2020 GB 9706.237-2020 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • 2008 GB 9706.9-2008 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment
  • 1997 GB 9706.9-1997 Medical electrical equipment--Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

GB 9706.9-2008 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment was changed to GB 9706.237-2020 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment

GB 9706.9-2008 -All Parts

GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance GB 9706.10-1997 Medical electrical equipment. Part 2: Particular requirements for safety of therapeutic X-ray generators GB 9706.103-2020 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment GB 9706.11-1997 Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis GB 9706.12-1997 Medical electrical equipment. Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment GB 9706.13-2008 Medical electrical equipment.Part 2:Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment GB 9706.14-1997 Medical electrical equipment--Part 2: Particular requirements for the safety of associated equipment of X-ray equipment GB 9706.15-2008 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems GB 9706.16-2015 Medical electrical equipment.Part 2:Particular requirements for the safety of radiotherapy simulators GB 9706.17-2009 Medical electrical equipment.Part 2:Particular requirements for the safety of gamma beam therapy equipment GB 9706.18-2006 Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray equipment for computed tomography GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment GB 9706.20-2000 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment GB 9706.201-2020 Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV GB 9706.202-2021 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories GB 9706.203-2020 Medical electrical equipment—Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment GB 9706.204-2022 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators GB 9706.205-2020 Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment GB 9706.206-2020 Medical electrical equipment—Part 2-6: Particular requirments for the basic safety and essential performence of microwave therapy equipment GB 9706.208-2021 Medical electrical equipment –Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV GB 9706.21-2003 Medical electrical equipment--Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors GB 9706.211-2020 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment GB 9706.212-2020 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators GB 9706.213-2021 Medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation GB 9706.216-2021 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment GB 9706.217-2020 Medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment GB 9706.219-2021 Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators GB 9706.22-2003 Medical electrical equipment--Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy GB 9706.222-2022 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment GB 9706.224-2021 Medical electrical equipment—Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers GB 9706.225-2021 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs GB 9706.226-2021 Medical electrical equipment—Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs GB 9706.227-2021 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment GB 9706.228-2020 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis GB 9706.229-2021 Medical electrical equipment—Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators GB 9706.23-2005 Medical electrical equipment-Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures GB 9706.236-2021 Medical electrical equipment—Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy GB 9706.237-2020 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment GB 9706.239-2021 Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment GB 9706.24-2005 Medical electrical equipment-Part 2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices



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