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 (English Version)

Standard No.
GB 9706.228-2020
Language
Chinese, Available in English version
Release Date
2020
Published By
国家市场监督管理总局、中国国家标准化管理委员会
Latest
GB 9706.228-2020
Replace
GB 9706.11-1997
Scope
This part of the GB 9706 series of standards applies to the basic safety and basic performance of X-ray tube assemblies and components expected to be used in medical diagnosis and imaging. Standards refer to X-ray tube assemblies. If a chapter or clause is specifically intended to apply only to ME EQUIPMENT or only to ME SYSTEMS, this will be stated in the title and content of that chapter or clause. If this is not the case, the Chapter or Regulation applies to both ME EQUIPMENT and ME SYSTEM. NOTE: This section also applies to the X-ray source assembly and the X-ray tube assembly of the X-ray tube head.

GB 9706.228-2020 history

  • 2020 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
  • 1997 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 9706.228-2020 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis has been changed from 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.

Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

GB 9706.228-2020 -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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