CN China
  • 11 - Medizintechnik

High flow oxygen inhaler, High flow respiratory therapeutic instrument, Transnasal high flow oxygen therapeutic instrument, Respiratory humidification therapeutic instrument

National Standard of the P.R.C., Medical Electrical Equipment — Part 2-90:Particular Requirements for Basic Safety and Essential Performance of Respiratory High Flow Therapy Equipment; (66 page(s), in Chinese)

This document specifies the basic safety and basic performance of high flow respiratory treatment equipment used in combination with accessories. Such medical devices are expected to be used for patients with spontaneous breathing; It is expected to be used in patients who need to improve alveolar gas exchange and who can benefit from receiving high flow humidified respiratory gas, including those whose upper respiratory tract is bypassed.

High flow respiratory therapy equipment can be: Fully integrated ME equipment; Or an ME system formed by a discrete product portfolio.

This document also applies to other types of respiratory devices with high flow respiratory treatment mode.

The high flow respiratory therapy device is operable when moving. The provisions of this document also apply to accessories intended by the manufacturer for connection to high flow respiratory therapy equipment, and the characteristics of such accessories may affect the basic safety and basic performance of high flow respiratory therapy equipment.