ISO 80601-2-90:2026

Overview

ISO 80601-2-90:2026 sets out the particular requirements for the basic safety and essential performance of respiratory high-flow therapy equipment. This international standard, developed by ISO, applies to medical electrical (ME) equipment and ME systems-either fully integrated devices or systems formed from separate components-specifically designed for delivering high-flow humidified respiratory gases to patients who can breathe spontaneously. These requirements ensure safe use for patients who benefit from enhanced alveolar gas exchange and humidification, including those needing airway clearance or experiencing types 1 or 2 respiratory failure.

This standard primarily targets equipment used in acute or infant care settings, predominantly hospitals, but also acknowledges growing usage in home healthcare environments. The document also covers accessories that may influence device safety and performance, such as breathing sets, connectors, humidifiers, filters, nasal cannulas, and airway interfaces.

Key Topics

ISO 80601-2-90:2026 addresses a wide range of critical topics crucial for manufacturers, healthcare professionals, and regulatory bodies. These include:

• Basic Safety Requirements: Specific protection against electrical, mechanical, and thermal hazards, ensuring the safety of both patients and operators.
• Essential Performance: Requirements for equipment accuracy and reliability, especially during oxygen delivery and humidification.
• Alarm Systems: Guidance on distributed alarm systems and their role in alerting operators to unsafe conditions.
• Electromagnetic Compatibility: Provisions for protection against electromagnetic disturbances to maintain consistent device functionality.
• Usability Considerations: Requirements for equipment setup and operation by users with personal protective equipment, addressing real-world hospital environments.
• Processing and Maintenance: Attention to cleaning, disinfection, and infection control practices to ensure safe reuse and minimize cross-infection risks.
• Accessories and Configurations: Evaluation and integration of accessories that may impact safety or essential performance, such as filters or nasal cannulas.
• System Recovery and Cybersecurity: Updated requirements to address modern risks including equipment security, data integrity, and recovery from interruptions.

Applications

Respiratory high-flow therapy equipment covered by this standard serves vital roles in various clinical scenarios:

• Acute Care and Intensive Care: Supporting patients experiencing hypoxemia (type 1 respiratory failure) or hypercapnia (type 2 respiratory failure) by improving gas exchange and reducing work of breathing.
• Neonatal and Pediatric Care: Providing non-invasive respiratory support for infants requiring humidified high-flow oxygen.
• Hospital Respiratory Units: As intermediate therapy in adults for critical care, post-surgical care, or palliative management.
• Home Healthcare (limited scope): While this standard focuses on hospital/acute care, it is also relevant to certain home-use devices with high-flow therapy functionalities, until a dedicated home-use standard is published.

The standard is applicable to standalone devices, integrated systems, and any respiratory equipment featuring a high-flow therapy mode. Accessories such as humidifiers, breathing circuits, and various airway interfaces must also comply with its requirements when their safety or effectiveness impacts the overall system.

Related Standards

ISO 80601-2-90:2026 works in conjunction with foundational and collateral standards within the ISO/IEC 60601 series. Key related standards include:

• ISO 80601-2-12: Critical care ventilators, especially with high-flow therapy modes.
• ISO 80601-2-13: Anaesthetic workstations with high-flow therapy functionalities.
• ISO 80601-2-72: Ventilators for home healthcare with high-flow therapy capability.
• ISO 80601-2-74: Requirements for respiratory humidifying equipment.
• IEC 60601-1: General safety and performance requirements for medical electrical equipment.
• IEC 60601-1-2/1-6/1-8/1-11: Electromagnetic compatibility, usability, alarms, and home healthcare requirements.

Manufacturers, designers, and clinical practitioners should consider all applicable collateral and particular standards to ensure comprehensive compliance and safe integration of high-flow respiratory therapy equipment in clinical environments.

Keywords: ISO 80601-2-90:2026, respiratory high-flow therapy, medical electrical equipment, safety requirements, essential performance, humidified oxygen, acute care, hospital respiratory devices, equipment standards, healthcare compliance