Medical electrical equipment - Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
1Key Takeaways
This technical document establishes essential safety and fundamental performance criteria specifically designed for high-flow respiratory therapy devices within the medical equipment sector. It addresses unique operational characteristics associated with these advanced therapeutic systems, ensuring that they meet rigor…
2Expert Interpretation
This article provides a detailed interpretation of the BS EN ISO 80601-2-90:2026 standard, covering the scope of high-flow-rate respiratory therapy devices, key requirements, major changes in the 2026 version (such as cybersecurity and SpO2 monitoring), a comparison of the standard framework, and implementation recommendations. It helps manufacturers and clinical institutions understand and apply the latest safety performance requirements.
Standard Overview and Background
BS EN ISO 80601-2-90:2026 is a special part of the series of standards for electrical equipment of medical devices, specifically addressing the basic safety and performance of **high-flow-rate respiratory therapy devices** (such as high-flow-rate nasal cannula oxygen therapy systems). This standard was jointly developed by ISO and IEC, with the 2026 version replacing the 2021 version. Major updates include: clarifying system recovery requirements, adding cybersecurity requirements, and adding SpO2 monitoring requirements. High-flow-rate respiratory therapy devices are used by spontaneously breathing patients to provide heated and humidified high-flow-rate gas, improving alveolar gas exchange, and are widely used in intensive care, respiratory departments, and home care.
Comparison of Major Technical Changes in Version 2026
| Dimensions of Change | Requirements for Version 2021 | New/Modified Features in Version 2026 | Impact Description |
|---|---|---|---|
| System Recovery | No specific requirements | Requires system recovery function, retains settings after recovery, and initiates an alarm (at least medium priority) | Reduces the risk of patient treatment interruption |
| Network Security | Not covered | According to IEC/TR 60601-4-5, requires security level SL-T (user interface level 1, remote update level 2), fire alarm function, etc. | To cope with network attacks and protect patient data security |
| SpO2 Monitoring | Not Mandatory | Recommended to integrate or specify SpO2 monitoring equipment that complies with ISO 80601-2-61 | Improve the timeliness of oxygenation monitoring |
| Alarm Log | Basic Requirements | Extended Log Content: Record all alarm events, setting changes, power switching, etc., with a capacity of at least 1000 entries, and retain records after power failure (365 days for home use / 7 days for other uses) | Enhance Event Tracing Capabilities |
| Power Interruption | Requires 30 minutes of internal power supply | Clearly define low battery alarms (10 minutes low priority, 5 minutes medium priority) and intelligent alarm suppression | Provide sufficient time to take alternative measures |
Key Requirements Explanation
201.4 Basic Performance
The standard specifies that basic performance includes: providing continuous humidified gas and oxygen concentration at the patient connection port, and meeting the claimed accuracy or triggering an alarm. In addition, a system recovery function is required: when a failure occurs that leads to performance loss, the device should attempt automatic recovery. During recovery, a medium-priority alarm should be issued if treatment is interrupted, and a low-priority alarm should be issued if there is no interruption. After recovery, the previous settings should be maintained; if the settings change, a medium-priority alarm should be issued.
201.12 Accuracy and Hazardous Output Protection
Flow Accuracy: The manufacturer must declare the error in the instruction manual. Testing includes minimum, average, and maximum flow points, converted to BTPS conditions. Oxygen Concentration Accuracy: Testing should be conducted at 30%, 60%, and the maximum set value, taking into account the effects of input oxygen concentration and flow rate. Maximum Limit Pressure: The protection device must prevent airway pressure from exceeding 60 hPa (60 cmH2O) for more than 200 ms. Flow Monitoring: Monitoring functionality should be provided, with a configurable alarm limit (20% deviation recommended).
Blockage Alarm: At least medium priority, intelligently suppressed.201.13 Fault Conditions
Gas Supply Failure: If there are multiple high-pressure gas sources, the equipment should maintain basic safety and trigger at least a low-priority alarm when one source fails. Functional Connection Interruption: When remote control or monitoring connection fails, the equipment should continue operation and issue a medium-priority alarm. Independence Requirement: A single fault must not simultaneously cause the delivery control function and protection devices to fail, or for the loss of function to go undetected.
201.14 Programmable Systems and Network Security
Programmable electronic subsystems (PESS) must comply with IEC 62304 (Software Lifecycle) and IEC 81001-5-1 (Network Security Activities). Flow control PESSs lacking independent external risk control measures must be at software security level C.
Cybersecurity capabilities include: clinical functions should be restored after the data interface is disconnected; fire alarm functions can be set and logged; security level SL-T: user interface authentication is not required, remote settings require authentication (SL-T Level 1), and remote updates require SL-T Level 2. Implementation Recommendations Manufacturers: 1) Pay attention to the new cybersecurity and SpO2 monitoring requirements in the 2026 version and incorporate security control measures during the product design phase. 2) Improve system recovery logic to ensure consistency of settings before and after recovery and meet alarm priority levels. 3) Update technical documentation, including network risk analysis and alarm log capacity descriptions. 4) Conduct compatibility testing on breathing tubing and accessories to ensure compliance with ISO 5356-1 connector requirements. 5) Pay attention to the anti-blocking design of the gas inlet and the fixing requirements during transportation (withstanding 1.0 g acceleration). Medical Institutions: 1) Confirm that the equipment complies with the new standards during procurement, especially the cybersecurity functions and SpO2 monitoring integration. 2) Train operators to familiarize themselves with viewing alarm logs and the confirmation process after system recovery. 3) For home-use equipment, ensure backup power connections and alarm testing instructions are provided. 4) Follow the manufacturer's instructions during regular maintenance and cleaning, paying attention to gas passage disinfection.Summary
BS EN ISO 80601-2-90:2026 provides a more comprehensive safety and performance framework for high-flow-rate respiratory therapy equipment, particularly strengthening system recovery, cybersecurity, and oxygenation monitoring. Manufacturers should assess gaps and update product designs early, and healthcare institutions need to update usage procedures to ensure compliance and patient safety. The implementation of this standard will improve the reliability and safety of high-flow-rate oxygen therapy.