YY 9706.287-2025 Medical electrical equipment—Part 2-87:Particular requirements for basic safety and essential performance of high-frequency ventilators
This document specifies the basic safety and performance requirements for high-frequency ventilators (HFV) used in combination with accessories (hereinafter referred to as "ME devices").
This document applies to patients who may be at risk of life-threatening conditions and require comprehensive care and continuous monitoring in professional medical institutions, operated by professional medical staff. It provides high-frequency ventilation of more than 150 breaths per minute for patients requiring different levels of artificial ventilation support, including those dependent on ventilators.
Note 1: In this document, such environments are referred to as critical care environments. High-frequency ventilators used in such environments are considered life-support devices.
Note 2: In this document, such high-frequency ventilators can provide transport in professional medical institutions (e.g., as a functioning ventilator during transport).
Note 3: High-frequency ventilators used for transport in professional medical institutions are not considered emergency medical service environment ventilators.
Note 4: HFVs are primarily categorized into three types:
— High-frequency percussive ventilation (HFPV, typical HFV frequency: 60 breaths per minute to 1,000 breaths per minute);
— High-frequency jet ventilation (HFJV, typical HFV frequency: 100 breaths per minute to 1,500 breaths per minute);
— High-frequency oscillatory ventilation (HFOV, typical HFV frequency: 180 breaths per minute to 1,200 breaths per minute, typically with an active exhalation phase).
Additionally, HFV nomenclature may be combined or used in conjunction with ventilators operating at a frequency below 150 breaths per minute.
*High-frequency ventilators are not considered physiological closed-loop control systems, unless they use patient physiological variables to adjust ventilation therapy settings.
This document also applies to accesso
Publish Date: 2025-02-26