Seventy-Six Standards of 9706 Series Listed by NMPA

Seventy-Six Standards of 9706 Series Listed by NMPA

Time Stamp: August 31, 2023 3:24 AM
Source Node: 2858138
standard number standard title effective date standard number to be replaced GB 9706.1-2020 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance 1-May-23 GB 9706.1-2007，GB 9706.15-2008，YY/T 0708-2009 YY 9706.102-2021 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility requirements and tests 1-May-23 YY 0505-2012 GB 9706.103-2020 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance Collateral standard: Radiation protection for diagnostic X-ray equipment 1-May-23 GB 9706.12-1997 YY/T 9706.106-2021 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability 1-May-23 N/A YY 9706.108-2021 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems 1-May-23 YY 0709-2009 YY/T 9706.110-2021 Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance Collateral standard: Requirements for the development of physiological closed-loop controllers 1-May-23 N/A YY 9706.111-2021 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home care environment 1-May-23 N/A YY 9706.112-2021 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical service environments 1-May-23 N/A GB 9706.201-2020 Medical electrical equipment – Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators with energies from 1 MeV to 50 MeV 1-May-23 GB 9706.5-2008 GB 9706.202-2021 Medical electrical equipment – Part 2-2: Particular requirements for basic safety and essential performance of high-frequency surgical equipment and high-frequency accessories 1-May-23 GB 9706.4-2009 GB 9706.203-2020 Medical electrical equipment – Part 2-3: Particular requirements for basic safety and essential performance of shortwave therapy equipment 1-May-23 YY 91087-1999，YY 91086-1999 GB 9706.205-2020 Medical electrical equipment – Part 2-5: Particular requirements for basic safety and essential performance of ultrasonic physiotherapy equipment 1-May-23 GB 9706.7-2008 GB 9706.206-2020 Medical electrical equipment – Part 2-6: Particular requirements for basic safety and essential performance of microwave therapy equipment 1-May-23 GB 9706.6-2007 GB 9706.208-2021 Medical electrical equipment – Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment with energies from 10kV to 1MV 1-May-23 GB 9706.10-1997 YY 9706.210-2021 Medical electrical equipment – Part 2-10: Particular requirements for basic safety and essential performance of nerve and muscle stimulators 1-May-23 YY 0607-2007 GB 9706.211-2020 Medical electrical equipment – Part 2-11: Particular requirements for basic safety and essential performance of gamma beam therapy equipment 1-May-23 GB 9706.17-2009 GB 9706.212-2020 Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of ventilators for intensive care 1-May-23 GB 9706.28-2006 GB 9706.213-2021 Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of anesthesia workstations 1-May-23 GB 9706.29-2006，YY 0635.1-2013，YY 0635.2-2009，YY 0635.3-2009，YY 0635.4-2009 GB 9706.216-2021 Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment 1-May-23 GB 9706.2-2003 GB 9706.217-2020 Medical electrical equipment – Part 2-17: Particular requirements for basic safety and essential performance of automatically controlled brachytherapy aftermarket equipment 1-May-23 GB 9706.13-2008 GB 9706.218-2021 Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment 1-May-23 GB 9706.19-2000 GB 9706.219-2021 Medical electrical equipment – Part 2-19: Particular requirements for basic safety and essential performance of infant incubators 1-May-23 GB 11243-2008 YY 9706.220-2021 Medical electrical equipment – Part 2-20: Particular requirements for basic safety and essential performance of infant transport incubators 1-May-23 YY 0827-2011 GB 9706.224-2021 Medical electrical equipment – Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and infusion controllers 1-May-23 GB 9706.27-2005 GB 9706.225-2021 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs 1-May-23 GB 10793-2000，YY 0782-2010 GB 9706.226-2021 Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs 1-May-23 GB 9706.26-2005 GB 9706.227-2021 Medical electrical equipment – Part 2-27: Particular requirements for basic safety and essential performance of cardiac monitoring equipment 1-May-23 GB 9706.25-2005,YY 1079-2008 GB 9706.228-2020 Medical electrical equipment – Part 2-28: Particular requirements for basic safety and essential performance of medical diagnostic X-ray tube assemblies 1-May-23 GB 9706.11-1997 GB 9706.229-2021 Medical electrical equipment – Part 2-29: Particular requirements for basic safety and essential performance of radiotherapy simulators 1-May-23 GB 9706.16-2015 YY 9706.233-2021 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis 1-May-23 YY 0319-2008 YY 9706.235-2021 Medical electrical equipment – Part 2-35: Particular requirements for basic safety and essential performance of heating equipment for medical blankets, pads or mattresses 1-May-23 YY 0834-2011 GB 9706.236-2021 Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of in vitro induced lithotripsy equipment 1-May-23 GB 9706.22-2003 GB 9706.237-2020 Medical electrical equipment – Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic diagnostic and monitoring equipment 1-May-23 GB 9706.9-2008 GB 9706.239-2021 Medical electrical equipment – Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment 1-May-23 GB 9706.39-2008 YY 9706.240-2021 Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of myoelectric and evoked response equipment 1-May-23 YY 0896-2013 YY 9706.241-2020 Medical electrical equipment – Part 2-41: Particular requirements for basic safety and essential performance of surgical shadowless lamps and diagnostic lamps 1-May-23 YY 0627-2008 GB 9706.243-2021 Medical electrical equipment – Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures 1-May-23 GB 9706.23-2005 GB 9706.244-2020 Medical electrical equipment – Part 2-44: Particular requirements for basic safety and essential performance of X-ray computed tomography equipment 1-May-23 GB 9706.18-2006 GB 9706.245-2020 Medical electrical equipment – Part 2-45: Particular requirements for basic safety and essential performance of mammography equipment and mammography stereotaxic devices 1-May-23 GB 9706.24-2005 YY 9706.250-2021 Medical electrical equipment – Part 2-50: Particular requirements for basic safety and essential performance of infant phototherapy equipment 1-May-23 YY 0669-2008 GB 9706.254-2020 Medical electrical equipment – Part 2-54: Particular requirements for basic safety and essential performance of radiography and fluoroscopy equipment 1-May-23 N/A YY 9706.257-2021 Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment for therapeutic, diagnostic, monitoring and plastic/cosmetic medical use 1-May-23 N/A GB 9706.260-2020 Medical electrical equipment – Part 2-60: Particular requirements for basic safety and essential performance of dental equipment 1-May-23 N/A YY 9706.262-2021 Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high-intensity ultrasound therapy (HITU) equipment 1-May-23 N/A GB 9706.263-2020 Medical electrical equipment – Part 2-63: Particular requirements for the basic safety and essential performance of dental X-ray machines for extraoral imaging 1-May-23 N/A GB 9706.265-2021 Medical electrical equipment – Part 2-65: Particular requirements for basic safety and essential performance of dental X-ray machines for intraoral imaging 1-May-23 N/A YY 9706.269-2021 Medical electrical equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrators 1-May-23 YY 0732-2009 YY 9706.221-2021 Medical electrical equipment – Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers 1-May-24 YY 0455-2011 GB 9706.222-2022 Medical electrical equipment – Part 2-22: Particular requirements for the basic safety and essential performance of laser equipment for surgical, orthopedic, therapeutic and diagnostic purposes 1-May-24 GB 9706.20-2000 YY 9706.234-2021 Medical electrical equipment – Part 2-34: Particular requirements for basic safety and essential performance of invasive blood pressure monitoring equipment 1-May-24 YY 0783-2010 YY 9706.247-2021 Medical electrical equipment – Part 2-47: Particular requirements for basic safety and essential performance of Holter systems 1-May-24 YY 0885-2013 YY 9706.252-2021 Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds 1-May-24 YY 0571-2013 YY 9706.270-2021 Medical electrical equipment – Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea therapy equipment 1-May-24 YY 0671.1-2009 YY 9706.272-2021 Medical electrical equipment – Part 2-72: Particular requirements for basic safety and essential performance of domestic ventilators used by ventilator-dependent patients 1-May-24 YY 0600.2-2007 GB 9706.204-2022 Medical electrical equipment – Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators 1-Aug-24 GB 9706.8-2009 YY 9706.274-2022 Medical electrical equipment – Part 2-74: Particular requirements for the basic safety and essential performance of respiratory humidification equipment 1-May-25 YY 0786-2010 YY 9706.258-2022 Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens extraction and vitrectomy equipment for ophthalmic surgery 1-Jun-25 N/A YY 9706.264-2022 Medical electrical equipment – Part 2-64: Particular requirements for basic safety and essential performance of light ion beam medical electrical equipment 1-Jun-25 N/A YY 9706.268-2022 Medical electrical equipment – Part 2-68: Particular requirements for basic safety and essential performance of X-ray image-guided radiotherapy equipment for electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment 1-Jun-25 N/A GB 9706.255-2022 Medical electrical equipment – Part 2-55: Particular requirements for basic safety and essential performance of respiratory gas monitors 1-Jan-26 Conversion of industry standards of YY 0601-2009 to national standard 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 1-Jan-26 N/A GB 9706.275-2022 Medical electrical equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment 1-Jan-26 N/A GB 9706.283-2022 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of household phototherapy equipment 1-Jan-26 N/A GB 9706.290-2022 Medical electrical equipment – Part 2-90: Particular requirements for basic safety and essential performance of high-flow respiratory therapy equipment 1-Jan-26 N/A YY 9706.230-2023 Medical electrical equipment – Part 2-30: Particular requirements for basic safety and essential performance of automatic non-invasive sphygmomanometers 15-Jan-26 YY 0667-2008，YY0670-2008 YY 9706.246-2023 Medical electrical equipment – Part 2-46: Particular requirements for basic safety and essential performance of operating tables 15-Jan-26 YY 0570-2013 YY 9706.249-2023 Medical electrical equipment – Part 2-49: Particular requirements for basic safety and essential performance of multiparameter patient monitors 15-Jan-26 YY 0668-2008 YY 9706.261-2023 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximetry equipment 15-Jan-26 YY 0784-2010 YY 9706.277-2023 Medical electrical equipment – Part 2-77: Particular requirements for basic safety and essential performance of robotically assisted surgical equipment 15-Jan-26 N/A YY 9706.231 Medical electrical equipment – Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power supply under revision YY 0945.2-2015 YY 9706.256 Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for temperature measurement under revision YY 0785-2010 GB/T 9706.266 Medical electrical equipment – Part 2-66: Particular requirements for basic safety and essential performance of hearing devices and hearing device systems under development N/A YY 9706.278 Medical electrical equipment – Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or mitigation under development N/A YY 9706.279 Medical Electrical Equipment Part 2-79: Particular Requirements for Basic Safety and Essential Performance of Respiratory Support Equipment for Respiratory Impairments under revision YY 0600.1-2007 YY 9706.280 Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of respiratory support equipment for respiratory insufficiency under revision YY 0600.1-2007 YY 9706.284 Medical electrical equipment – Part 2-84: Particular requirements for basic safety and essential performance of emergency ventilators under revision YY 0600.3-2007

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