GB 9706.5-1992
Medical electrical equipment.Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV

2010-02
Standard No.
GB 9706.5-1992
Language
Chinese
Release Date
1992
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Replace By
GB 9706.5-2008
GB 9706.15-1999
Lastest
GB 9706.201-2020
GB 9706.1-2020
GB 9706.227-2021
Scope
This chapter of the "General Requirements" applies except for the modification of the following provisions. This standard applies to medical electron accelerators for the purpose of human treatment. The X-radiation or electron radiation beams produced by it have a nominal energy range of 1 to 50 MeV and are designed to be used at a distance of 0.5 to 0.5 MeV from the radiation source. The maximum absorbed dose rate at a normal treatment distance of 2m (both refer to water, the same below) is between 0.001 and 1gY·s-1. This standard also applies to equipment that automatically selects and displays operating parameters under the control of a programmed electronic system. This standard ensures that the accelerator: a. Given the preselected radiation type. b. Given a preselected radiant energy. c. Give the preselected absorbed dose. d. Irradiation according to the preselected relationship of the radiation beam to the patient (eg: fixed beam therapy, moving beam therapy, beam limiting device, etc.). e. The radiation produced will not cause harm to patients, operators, other personnel or the surrounding environment. This standard applies to equipment that must be used under the supervision of trained personnel. This standard deals with radiation safety, electrical and mechanical safety. The hardware and software design of the computer and microprocessor system used to measure the absorbed dose data in the radiation must comply with this standard. The safety provisions of this standard apply to computer-based systems. This standard contains inspection methods for reviewing radiation safety, electrical and mechanical safety requirements. Provide inspection methods only for those items that are subject to audit inspection.

GB 9706.5-1992 history

  • 2020 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
  • 2008 GB 9706.5-2008 Medical electrical equipment.Part 2-1:particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
  • 1992 GB 9706.5-1992 Medical electrical equipment.Particular requirements for the safety of medical electron accelerators in the range 1 MeV to 50 MeV

GB 9706.5-1992 -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 GB 9706.243-2021 Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures GB 9706.244-2020 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography GB 9706.245-2020 Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices GB 9706.25-2005 Medical electrrical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment GB 9706.254-2020 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy GB 9706.255-2022 Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors GB 9706.26-2005 Medical electrical equipment.Part 2: Particular requirements for the safety of electroencephalographs GB 9706.260-2020 Medical electrical equipment—Part 2-60: Paticular requirments for the basic safety and essential performance of dental equipment GB 9706.263-2020 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment GB 9706.265-2021 Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment GB 9706.27-2005 Medical electrical equipments.Part 2-24: Particular requirements for the safety of infusion pumps and controllers GB 9706.271-2022 Medical electrical equipment—Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment GB 9706.275-2022 Medical electrical equipment—Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment GB 9706.28-2006 Medical electrical equipment.Part 2:Particular requirements for the safety of lung ventilators.Critical care ventilators GB 9706.283-2022 Medical electrical equipment—Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment GB 9706.29-2006 Medical electrical equipment.Part 2:Particular requirements for the safety and essential performance of anaesthetic systems GB 9706.290-2022 Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment GB 9706.3-2000 Medical electrical equipment-Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators GB 9706.39-2008 Medical electrical equipment.Part 2-39:Particular requirements for the safety of peritoneal dialysis equipment GB 9706.4-2009 Medical electrical equipment-Part2-2:Particular requirements for the safety of high frequency surgical equipment GB 9706.5-2008 Medical electrical equipment.Part 2-1:particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV GB 9706.6-2007 Medical electrical equipment.Part 2:Particular requirements for the safety of microwave therapy equipment GB 9706.7-2008 Medical electrical equipment.Part2-5:Particular requirements for the safety of ultrasonic physiotherapy equipment GB 9706.8-2009 Medical electrical equipment-Part2-4:Particular requirements for the safety of cardiac defibrillators GB 9706.9-2008 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment



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