The NMPA summarized 76 Medical Electrical Standards, GB 9706 Series, which is equivalent to IEC60601.
The standards have been effective since May 1, 2023. For active product manufacturers with existing NMPA certificates, grace period has been granted to comply by December 31, 2025.
Read more about the impacts from the standards and the testing requirements.
Complete List of GB 9706 Standards
For an English copy of any standards listed below, please email us at info@ChinaMedDevice.com
| 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 |