Medical Electrical Equipment is a set of standards that have been updated by the National Standardization Administration since 2020. The author isNational Standardization Administration。
Part 2-55 is modified to adopt the ISO international standard: ISO 80601-2-55:2018.[34]
Part 2-71 is modified to adopt the IEC international standard: IEC 80601-2-71:2015.[35]
Part 2-75 is modified to adopt the IEC international standard: IEC 60601-2-75:2017.[36]
Part 2-83 is modified to adopt the IEC international standard: IEC 60601-2-83:2019.[37]
Part 2-90 is modified to adopt the ISO international standard: ISO 80601-2-90:2011.[38]
content validity
Announce
edit
For the convenience of use, the standard has made the following editorial changes:
——The foreword of IEC 61676:2002 is deleted;
——In Chapter 2 "Normative References", the referenced IEC, ISO and other standards, which have been equivalent converted into national standards (including metrological verification regulations), shall be replaced by national standards.
——In Chapter 3 "Terms and Definitions", the English of terms is not small capital letters, but small letters;
——Replace the comma "," as the decimal point with the decimal point symbol ".".
Appendix A, Appendix B and Appendix c of this standard are informative.
This standard is proposed by and under the jurisdiction of the Subcommittee on Standardization of Radiotherapy, Nuclear Medicine and Radiodosimetry Equipment (SAC/TC 10/SC 3).
This standard is drafted by Beijing Medical Device Inspection Institute.
Main drafters of this standard: Wang Peichen, Zhang Zhaoyuan, Song Lianyou.
New version catalogue
Announce
edit
GB 9706.1-2020 Medical electrical equipment -- Part 1: General requirements for basic safety and basic performance[2]
GB 9706.103-2020 Medical electrical equipment -- Part 1-3: General requirements for basic safety and basic performance -- Collateral standard: Radiation protection for diagnostic X-ray equipment[23]
GB 9706.201-2020 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and basic performance of electron accelerators with energies from 1 MeV to 50 MeV[10]
GB 9706.202-2021 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories[3]
GB 9706.203-2020 Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and basic performance of short wave therapeutic equipment[28]
GB 9706.204-2022 Medical Electrical Equipment Part 2-4: Particular Requirements for Basic Safety and Basic Performance of Cardiac Defibrillators[1]
GB 9706.205-2020 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and basic performance of ultrasonic physiotherapy equipment[4]
GB 9706.206-2020 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and basic performance of microwave therapy equipment[24]
GB 9706.208-2021 Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and basic performance of therapeutic X-ray equipment with energies from 10kV to 1MV[25]
GB 9706.211-2020 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and basic performance of gamma beam therapy equipment[13]
GB 9706.212-2020 Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and basic performance of critical care ventilators[19]
GB 9706.213-2021 Medical electrical equipment - Part 2-13: Particular requirements for the basic safety and basic performance of anesthesia workstations[20]
GB 9706.216-2021 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment[5]
GB 9706.217-2020 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and basic performance of automatically controlled brachytherapy afterloading equipment[11]
GB 9706.218-2021 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and basic performance of endoscopic equipment[15]
GB 9706.219-2021 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators[22]
GB 9706.222-2022 Medical Electrical Equipment Part 2-22: Particular Requirements for Basic Safety and Basic Performance of Laser Equipment for Surgery, Plastic Surgery, Treatment and Diagnosis[32]
GB 9706.224-2021 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and basic performance of infusion pumps and infusion controllers[18]
GB 9706.225-2021 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and basic performance of electrocardiographs[21]
GB 9706.226-2021 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and basic performance of electroencephalographs[17]
GB 9706.227-2021 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and basic performance of ECG monitoring equipment[27]
GB 9706.228-2020 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and basic performance of medical diagnostic X-ray tube assemblies[26]
GB 9706.229-2021 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and basic performance of radiotherapy simulators[12]
GB 9706.236-2021 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and basic performance of extracorporeal lithotripsy equipment[16]
GB 9706.237-2020 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment[6]
GB 9706.239-2021 Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and basic performance of peritoneal dialysis equipment[7]
GB 9706.243-2021 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and basic performance of X-ray equipment for interventional procedures[8]
GB 9706.244-2020 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and basic performance of X-ray computed tomography equipment[14]
GB 9706.245-2020 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and basic performance of mammography equipment and mammography stereo positioning devices[9]
GB 9706.254-2020 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment[30]
GB 9706.255-2022 Medical Electrical Equipment Part 2-55: Special Requirements for Basic Safety and Basic Performance of Respiratory Gas Monitors[34]
GB 9706.260-2020 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment[29]
GB 9706.263-2020 Medical Electrical Equipment Part 2-63: Special Requirements for Basic Safety and Basic Performance of Dental X-ray Machines for Extraoral Imaging[33]
GB 9706.265-2021 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and basic performance of intraoral imaging dental X-ray machines[31]
GB 9706.271-2022 Medical Electrical Equipment Part 2-71: Special Requirements for Basic Safety and Basic Performance of Functional Near Infrared Spectroscopy (NIRS) Equipment[35]
GB 9706.275-2022 Medical Electrical Equipment Part 2-75: Particular Requirements for Basic Safety and Basic Performance of Photodynamic Therapy and Photodynamic Diagnostic Equipment[36]
GB 9706.283-2022 Medical Electrical Equipment Part 2-83: Particular Requirements for Basic Safety and Basic Performance of Household Phototherapeutic Equipment[37]
GB 9706.290-2022 Medical Electrical Equipment Part 2-90: Particular Requirements for Basic Safety and Basic Performance of High Flow Respiratory Therapy Equipment[38]
