ISO 80601-2-90 Medical Electrical Equipment - Part 2-90: Special Requirements for Essential Safety and Essential Performance of Respiratory High Flow Therapy Equipment

Medical Device Tests

ISO 80601-2-90 Medical Electrical Equipment - Part 2-90: Special Requirements for Essential Safety and Essential Performance of Respiratory High Flow Therapy Equipment

EUROLAB laboratory provides testing and compliance services within the scope of ISO 80601-2-90 standard. This part of the ISO 80601 standard, developed by the International Standards Organization (ISO), applies to the basic safety and basic performance of respiratory high-flow therapy equipment, hereinafter also referred to as ME equipment or ME system with its accessories.

ISO 80601-2-90 Medical Electrical Equipment - Part 2-90: Special Requirements for Essential Safety and Essential Performance of Respiratory High Flow Therapy Equipment

The ME system is designed for use in spontaneously breathing patients and is intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from inhaling high-flow humidified respiratory gases, which may include a patient with an upper airway bypass.

For example, patients with Type 1 Respiratory Failure exhibiting a reduction in arterial blood oxygenation, patients who would benefit from properly reduced respiratory work in Type 2 Respiratory failure with high arterial carbon dioxide,
patients who need hydration to improve mucociliary clearance.

Respiratory high flow therapy equipment can be designed for use in a home healthcare setting or professional healthcare facilities. In a home healthcare setting, the supply network is often unreliable.

Respiratory high flow therapy equipment can be:

  • Fully integrated ME equipment or
  • A combination of individual elements that make up an ME system.

This standard also applies to other types of respiratory equipment where the equipment includes a high flow mode of respiratory therapy. This standard and ISO 80601-2-12 are applicable to a critical care ventilator with a high flow therapy mode. Respiratory high flow therapy equipment can be operated in transit.

This document also applies to accessories that are intended by their manufacturers to be connected to respiratory high flow therapy equipment and where the characteristics of these accessories may affect the essential safety or basic performance of respiratory high flow therapy equipment .

E.g; breathing sets, connectors, humidifier, respiratory system filter, external electrical power supply, distributed alarm system, high flow nasal cannula, tracheal tube, tracheostomy tube, face mask, and supra-laryngeal airway.

If an article or sub-article is specifically intended to be applicable to ME equipment only or ME systems only, the title and content of that article or sub-article shall say so. If this is not the case, the item or sub-clause applies to both ME equipment and ME systems as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems covered by this document are not covered by the specific requirements in this document other than the general standard.

ISO 80601-2-90 does not specify requirements for:

  • Ventilators or accessories for ventilator-dependent patients for critical care applications provided in ISO 80601‑2‑12;
  • Ventilators or accessories for anesthetic applications given in ISO 80601‑2‑13;
  • Ventilators or accessories for the emergency medical services environment provided in ISO 80601‑2‑84;
  • Ventilators or accessories for ventilator-dependent patients in a home care setting, as provided in ISO 80601‑2‑72;
  • Respiratory support equipment or accessories for patients with respiratory failure, given in ISO 80601‑2‑79;
  • Respiratory support equipment or accessories for patients with respiratory failure, given in ISO 80601‑2‑80;
  • sleep apnea treatment ME equipment provided in ISO 80601‑2‑70;
  • Continuous positive airway pressure (CPAP) ME equipment;
  • high frequency jet fans (HFJVs) given in ISO 80601‑2‑87;
  • Gas mixers for medical use given in ISO 11195;
  • Flow meters given in ISO 15002;
  • high frequency oscillating ventilators (HFOVs) in ISO 80601‑2‑87;
  • Armor or "iron-lung" ventilation equipment.

Among the services provided by our organization within the framework of material testing services, there are also ISO 80601-2-90 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.

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