YY 9706.279-2023
Medical electrical equipment Part 2-79: Specific requirements for basic safety and essential performance of respiratory support equipment for respiratory dysfunction (English Version)
- Standard No.
- YY 9706.279-2023
- Language
- Chinese, Available in English version
- Release Date
- 2023
- Published By
- 国家药监局
- Latest
- YY 9706.279-2023
- Replace
- YY 0600.1-2007
- Scope
- This document specifies the basic safety and essential performance of respiratory support equipment used in combination with accessories for respiratory dysfunction. This document applies to respiratory support devices intended for use in patients with respiratory dysfunction in a home care setting by inexperienced operators. This document also applies to accessories intended by the manufacturer to be connected to the respiratory system of a respiratory support device for patients with respiratory impairment and whose characteristics may affect the basic safety and essential performance of the respiratory support device for patients with respiratory impairment. This document does not apply to equipment for patients who rely on artificial ventilation for life support in real time, intensive care ventilators and their accessories, anesthesia ventilators and their accessories, emergency and transport ventilators and their accessories, home ventilators for ventilator-dependent patients. machine, respiratory support equipment for respiratory insufficiency, medical electrical equipment for the treatment of obstructive sleep apnea, continuous positive airway pressure medical electrical equipment, high-frequency jet ventilator, high-frequency oscillation ventilator, constant flow oxygen therapy equipment , iron armor and "iron lung" ventilator.
YY 9706.279-2023 history
- 2023 YY 9706.279-2023 Medical electrical equipment Part 2-79: Specific requirements for basic safety and essential performance of respiratory support equipment for respiratory dysfunction
YY 9706.279-2023 Medical electrical equipment Part 2-79: Specific requirements for basic safety and essential performance of respiratory support equipment for respiratory dysfunction has been changed from YY 0600.1-2007 Lung ventilators for medical use-Particular requirements for basic safety and essential performance-Part 1:Home-care ventilatory support devices.
