What is ISO 80601‑2‑90 about?
ISO 80601 series discusses standards for medical electrical equipment. ISO 80601‑2‑90 guides you about safety and performance of respiratory high-flow therapy equipment. This medical electrical (ME) equipment or ME system, in combination with its accessories, is used for patients who can breathe spontaneously, as well as patients who would benefit from improved alveolar gas exchange, and who would benefit from high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
Respiratory high-flow therapy equipment can be used in the home healthcare environment or in professional healthcare facilities.
ISO 80601‑2‑90 applies to respiratory high-flow therapy equipment that can be fully integrated ME equipment, or a combination of separate items forming a ME system.
Note: ISO 80601‑2‑90 and ISO 80601-2-12[14] apply to a critical care ventilator with a high-flow therapy mode.
Note: ISO 80601‑2‑90 does not specify the requirements for ventilators or accessories for ventilator-dependent patients intended for critical care applications, ventilators or accessories intended for aesthetic applications, ventilators or accessories intended for the emergency medical services environment, ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, ventilatory support equipment or accessories intended for patients with ventilatory impairment, ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, sleep apnoea therapy ME equipment, continuous positive airway pressure (CPAP) ME equipment, high-frequency jet ventilators (HFJVs), gas mixers for medical use, flowmeters, high-frequency oscillatory ventilators (HFOVs), and cuirass or “iron-lung” ventilation equipment.
Who is ISO 80601‑2‑90 for?
ISO 80601‑2‑90 on basic safety and essential performance requirements of respiratory high-flow therapy equipment is useful for:
- Manufacturers and suppliers of medical electrical equipment
- Testing centres of medical electrical equipment
- Manufacturers of respiratory high-flow therapy equipment
- Home healthcare environments and professional healthcare facility centres
- Manufacturers of accessories used for respiratory high-flow therapy equipment
Why should you use ISO 80601‑2‑90?
Respiratory high-flow therapy equipment has been used successfully for years with neonatal patients. In recent years there is more information about treating adults with respiratory high-flow therapy equipment when it is used as an intermediate therapy to improve oxygenation in adult critical care patients, respiratory care units and for palliative care. High-flow therapy equipment is also used in the treatment of chronic respiratory disease to reduce exacerbation, improve physiological outcomes and quality of life. The use of respiratory high-flow therapy equipment continues to increase as it is easily set up and is well tolerated by patients.
Since the outbreak of COVID-19 in January of 2020, its spread has been rapid and fierce. In hospitals across the world, all kinds of respiratory high-flow therapy equipment have been widely used. In general, there is a trend to use more non-invasive respiratory therapy equipment. With the spread of the epidemic globally, the demand for ISO 80601‑2‑90 is clear and very urgent.
Following ISO 80601‑2‑90 design guidelines, will help you ensure safety and performance of respiratory high-flow therapy equipment such as protection against electrical hazards from ME equipment, indication of duration of operation, respiratory high-flow therapy equipment security, and more for respiratory high-flow therapy equipment.
ISO 80601‑2‑90 also provides solutions for problems such as the instability of gas supply from a high-pressure inlet, insufficient oxygen being delivered to the patient, related alarm conditions, infectious exhaled gas, and more related to respiratory high-flow therapy equipment.
ISO 80601‑2‑90 will help you in the manufacturing process and in avoiding accidents while operating the respiratory high-flow therapy equipment and can provide recognized solutions for patients’ health and safety.
