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Electrical Safety Testing Standards for Medical Devices
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Electrical Safety Of Medical Devices
GB 9706.1-2020, GB9706.1-2007 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
GB 9706.1 specifies the general requirements for basic safety and essential performance of ME equipment and ME systems.
GB 9706.1 applies to medical electrical equipment and medical electrical systems.
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
YY 9706.102 applies to the basic safety and essential performance requirements of medical electrical equipment and medical electrical systems.
YY 9706.102 specifies electromagnetic compatibility requirements for medical electrical equipment and medical electrical systems.
YY 9706.102 specifies general requirements and test methods for electromagnetic compatibility of medical electrical equipment and medical electrical systems. These requirements and tests, together with the provisions of the general standard, also serve as the basis for particular standards.
YY 0505-2012 Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests
GB 9706.103-220 Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection of diagnostic X-ray equipment
YY/T 9706.106-2021 Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral Standard: Usability
YY/T 9706.106 specifies the processes that manufacturers shall use to analyze, define, design, verify, and validate the usability of medical electrical equipment in relation to basic safety and essential performance.
YY/T 9706.108-2021 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems
YY/T 9706.108 applies to the basic safety and essential performance requirements of medical electrical equipment and medical electrical systems.
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
YY/T 9706.110 specifies requirements for the development process (analysis, design, verification, and validation) of physiological closed-loop controllers (PCLC) used in physiological closed-loop control systems (PCLCS) for regulating physiological variables in medical electrical equipment and medical electrical systems.
YY/T 9706.110 applies to various types of PCLC, including linear and nonlinear methods, adaptive techniques, fuzzy logic, neural networks, and other approaches.
YY/T 9706.110 does not include additional mechanical requirements or additional electrical requirements.
YY/T 9706.110 applies to closed-loop controllers that regulate physiological variables by adjusting the controller output variable and associating it with a reference variable (i.e., changing or maintaining measured physiological variables).
YY/T 9706.110 does not apply to closed-loop controllers using feedback data derived from non-patient measurements to maintain physical or chemical variables.
YY/T 9706.111-2021Medical 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 home care environments
YY/T 9706.111 specifies the basic safety and essential performance requirements for medical electrical equipment and medical electrical systems intended for use in home care environments.
YY/T 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
YY/T 9706.112 specifies the basic safety and essential performance requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical service environments.
YY/T 9706.112 applies to medical electrical equipment and medical electrical systems intended for use in emergency medical service environments as specified in the manufacturer’s instructions for use.
YY/T 9706.112 does not apply to medical electrical equipment and medical electrical systems that comply only with YY 9706.111 for home care environments, or equipment that complies only with GB 9706.1 but does not comply with YY 9706.111 or this standard, when used in specialized medical institutions.
GB 9706.222-2022 Medical electrical equipment — Part 2-22: Particular requirements for basic safety and essential performance of surgery, orthopedics, treatment and diagnosis
YY 0668-2008 Medical electrical equipment—Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
YY 0670-2008 Non-invasive automated sphygmomanometer
YY 9706.234-2021 Medical electrical equipment—Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
YY 9706.234 specifies the basic safety and essential performance requirements for invasive blood pressure monitoring equipment.
YY 9706.234 applies to invasive blood pressure monitoring equipment, including associated sensors, used for internal measurement or monitoring of pressure within the circulatory system.
YY 9706.234 does not apply to puncture catheters, puncture needles, Luer fittings, valves, or valve manifolds used for connecting pressure-transmitting diaphragms.
YY 9706.234 does not apply to non-invasive blood pressure monitoring equipment.
YY 9706.235-2021 Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of medical blanket, mattress or mattress heating equipment
YY 9706.235 specifies the basic safety and essential performance requirements for medical blankets, pads, and mattress-type heating equipment classified as medical electrical equipment.
YY 9706.235 applies to medical blankets, pads, and mattress-type heating equipment, including equipment intended for preheating beds.
YY 9706.235 does not apply to:heating devices; infant radiant warmers; infant incubators; transport incubators; and cooling equipment.
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 treatment, diagnosis, monitoring and plastic/cosmetic surgery
YY 9706.257 applies to equipment using one or more non-laser optical radiation sources within the wavelength range of 200 nm to 3000 nm, intended to produce non-visual photobiological effects on humans or animals for therapeutic, diagnostic, monitoring, cosmetic, aesthetic, or veterinary applications.
YY 9706.257 does not apply to tanning equipment, ophthalmic instruments, or infant phototherapy equipment.
YY 9706.269-2021 Medical electrical equipment—Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
YY 9706.269 specifies the particular requirements for the basic safety and essential performance of oxygen concentrators and their accessories.Oxygen concentrators are intended to increase the oxygen concentration of gas delivered to individual patients. Such equipment is typically used in home care environments and may also be used during transportation, including private vehicles, public transportation, and commercial aircraft.This standard applies to both transportable and non-transportable oxygen concentrators.
YY 9706.269 applies to oxygen concentrators integrated with or used in combination with other medical devices, ME equipment, or ME systems.
YY 9706.272-2021 Medical electrical equipment—Part 2-72: Particular requirements for basic safety and essential performance of domestic ventilators for ventilator-dependent patients
YY 9706.272 specifies the basic safety and essential performance requirements for ventilators and their accessories (hereinafter referred to as ME equipment) intended for use in home care environments, operation by untrained users, and patients who are ventilator-dependent.
YY 9706.272 is not applicable to continuous positive airway pressure (CPAP) ME equipment, high-frequency jet ventilators (HFJV), or high-frequency oscillatory ventilators (HFOV).
YY 9706.272 is not applicable to the requirements for iron lungs and “iron lung” ventilators.
YY 9706.272 is not applicable to the requirements for intensive-care ventilators and their accessories. Such requirements are specified in GB 9706.28.
YY 9706.272 is not applicable to the requirements for anesthesia ventilators and their accessories. Such requirements are specified in GB 9706.29.
YY 9706.272 is not applicable to the requirements for emergency and transport ventilators and their accessories. Such requirements are specified in YY 0600.3.
YY 9706.272 is not applicable to home-care ventilatory support devices intended solely to augment the tidal volume of patients with spontaneous breathing. Such requirements for ventilators and their accessories are specified in YY 0600.1.
YY 9706.272 is not applicable to ME equipment intended for the treatment of obstructive sleep apnea. Such requirements are specified in YY 9706.270 (ISO 80601-2-70).
YY 9706.272 is a particular standard within the GB 9706.1 series of standards.
YY 9706.274-2022 Medical electrical equipment—Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
YY 9706.274 specifies the basic safety and essential performance requirements for humidifiers and their combinations with accessories.
YY 9706.274 also applies to accessories intended by manufacturers for use with humidifiers, where the characteristics of these accessories may affect the basic safety and essential performance of the humidifier.
YY 9706.274 includes requirements for humidification functions used in various medical applications.
YY 9706.274 also includes requirements for active HME (Heat and Moisture Exchanger) equipment, which enhances the humidity level of gas delivered to the patient’s lungs through active heating and humidification.
YY 9706.274 does not apply to passive HME equipment, where part of the patient’s exhaled moisture and heat is returned to the breathing circuit during inspiration without adding additional moisture or heat.
YY 9706.274 does not specify requirements for cold-reheat humidifiers or bubble humidifiers.
YY 9706.274 does not apply to commonly known “indoor humidifiers”, humidifiers used in heating, ventilation, and air-conditioning systems, or humidifiers integrated into infant incubators.
YY 9706.274 is not intended for use with nebulizers that deliver medication to patients.
YY 0784-2010Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment
YY 0785-2010 Clinical thermometers — Performance of electrical thermometers for continuous measurement
YY 0601-2009 Anesthesia Gas Monitor Anesthetic gas monitors
YY 0785-2010 Clinical thermometers — Performance of electrical thermometers for continuous measurement
TT 0667-2008 Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic circulation non-invasive blood pressure monitoring equipment
YY 1057-2016 General specifications for medical foot switch
YY 1057 specifies the terms and definitions, performance requirements, safety requirements, and test methods for medical foot switches.
YY 1057 applies to foot switches used as control circuit components in medical electrical equipment.
YY 1057 does not apply to pneumatic or hydraulic foot switches.
YY/T 1738-2020 Energy consumption measurement methods for medical electrical equipment
YY/T 1738 specifies the methods for measuring and calculating the energy consumption of medical electrical equipment and systems (hereinafter referred to as ME equipment and ME systems).
YY/T 1738 applies to mains-powered ME equipment and ME systems.
YY/T 1738 does not apply to ME equipment and ME systems powered solely by internal power supplies.
GB/T 14710-2009 The environmental requirement and test methods for medical electrical equipment
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