GB 9706.290-2022
Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment (English Version)

Standard No.

GB 9706.290-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB 9706.290-2022

Scope

There are key scenario differences between high-flow respiratory therapy devices and ventilators intended for use by ventilator-dependent patients. One of these differences is the patient's ability to maintain adequate voluntary ventilation of the lungs, and another is the relationship between mechanical ventilation and other important lifestyle functions (e.g., diet, speech, psychosocial aspects, and general physical activity). balance between. When selecting and configuring modes, circuits, and alarm states, supervising clinicians and patients need to balance awareness and certainty of mechanical ventilation based on factors such as the patient's clinical needs, autonomy, and lifestyle. There is a growing interest in alternatives to traditional oxygen therapy (ie, heated and humidified high-flow oxygen therapy). This form of respiratory support can be provided by a variety of airway devices. This support typically delivers a mixture of air and oxygen to the patient at higher delivery rates than in traditional oxygen therapy and is designed to minimize entrainment of room air. Clinicians often refer to this approach as "high-flow nasal oxygen therapy," "nasal high-flow therapy," "high-flow oxygen therapy," or "humidified high-flow therapy." Several physiological effects of the use of high-flow respiratory therapy devices have been described previously: — flushing of throat dead space; — reduction of nasopharyngeal resistance; — positive expiratory pressure effect; — alveolar recruitment ; - improved humidity, comfort, and patient tolerance; - better control of lung oxygen concentrations; and - mucociliary clearance. [ ] See ISO/TR2195417 for additional information. High-flow respiratory therapy devices conforming to this document are expected to provide adequate gas exchange for a wide range of patients. These may include patients with pulmonary vascular dysfunction, such as patients with 2019-nCoV with an oxygen-dependent phenotype. Positive pharyngeal pressure has been observed to be generated by delivering high flow through nasal cannula, and a flow of 10 L/min during exhalation typically produces a positive pressure of up to about 1 hPa. The pressure generated depends not only on the flow rate, but also on the ratio of the cross-sectional area of the prongs to the nostrils, and whether the mouth is closed. High-flow respiratory therapy equipment usually consists of 5 parts: 1) gas source connection: ---air; and ---oxygen; Note 1: gas source includes medical gas pipeline system, gas cylinders, oxygen generator and ambient air. 41 GB9706.290—2022

GB 9706.290-2022 Referenced Document

• GB 50751 Technical code for medical gases engineering
• GB/T 14574-2000 Acoustics-Declaration and verification of noise emission values of machinery and equipment
• GB/T 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane
• GB/T 3785.1 Electroacoustics—Sound level meters—Part 1: Specifications*， 2023-05-23 Update
• IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
• ISO 18190:2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
• ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
• ISO 7396-1 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum AMENDMENT 1
• ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• YY 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators
• YY 9706.102-2021 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standards: Electromagnetic compatibility requirements and tests
• YY 9706.108-2021 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standards: General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems
• YY 9706.111-2021 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems used in home care environments
• YY 9706.112 Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envir
• YY/T 0753.1-2009 Breathing system filters for anaesthetic and respiratory use.Part 1:Salt test method to assess filtration performance
• YY/T 0753.2-2009 Breathing system filters for anaesthetic and respiratory use.Part 2:Non-filtration aspects
• YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases
• YY/T 0916.1-2021 Small bore connections for medical liquids and gases Part 1: General requirements
• YY/T 1778.1-2021 Biocompatibility evaluation of respiratory gas pathways in medical applications Part 1: Evaluation and testing during risk management
• YY/T 9706.106-2021 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standards: Availability

GB 9706.290-2022 history

• 2022 GB 9706.290-2022 Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment

GB 9706.290-2022 -All Parts