SIST EN ISO 80601-2-90:2026

Overview

SIST EN ISO 80601-2-90:2026 outlines the particular requirements for the basic safety and essential performance of respiratory high-flow therapy equipment and their accessories. This international standard, prepared by ISO/TC 121 and CEN/TC 215, serves as a crucial reference for manufacturers, regulatory authorities, and healthcare providers to ensure the safety, reliability, and performance of medical devices used for high-flow respiratory therapy.

The scope covers medical electrical (ME) equipment and systems designed to deliver high-flow, humidified respiratory gases to patients who can breathe spontaneously and would benefit from improved gas exchange. Examples include acute care for patients with respiratory failure, those requiring reduced work of breathing, or improved mucociliary clearance. The standard primarily applies to equipment for hospital use, including neonatal and acute care settings, and addresses both fully integrated equipment and system configurations made from compatible components.

Key Topics

• Basic Safety and Essential Performance: The standard details requirements to ensure that respiratory high-flow therapy equipment operates safely under normal and single-fault conditions, minimizing risks related to electrical, mechanical, and thermal hazards.
• Equipment Scope: Includes devices intended for spontaneously breathing patients, such as those with Type 1 or Type 2 respiratory failure and patients needing airway humidification.
• Accessory Integration: Requirements extend to accessories-such as humidifiers, breathing circuits, connectors, filters, high-flow nasal cannulas, tracheal and tracheostomy tubes-which, when combined with equipment, may affect safety and performance.
• Alarm and Monitoring Systems: Addresses alarm systems, display of operational status, and usability under challenging conditions (e.g., by operators wearing personal protective equipment).
• System and Environmental Compatibility: Covers both standalone and integrated systems, as well as transit-operable equipment, which may be used across various care environments.
• Exclusions: This standard does not address requirements for ventilators for critical care, anaesthetic applications, or homecare environments, which are specified in related standards.

Applications

Respiratory high-flow therapy equipment compliant with ISO 80601-2-90:2026 is widely used in:

• Acute care settings: Hospitals, emergency rooms, and intensive care units use high-flow therapy equipment for patients in acute respiratory distress or with hypoxemia.
• Infant and neonatal care: Pediatric and neonatology departments rely on the controlled delivery of oxygen and humidity for vulnerable patients.
• Post-surgical and palliative care: Ensures respiratory support for spontaneously breathing patients recovering from surgery or requiring symptom management.
• Professional healthcare facilities: Equipment is designed for robust routine use and subject to institutional maintenance protocols.
• Home healthcare (future guidance): While this standard focuses on acute and hospital-based care, future standards will address long-term home use.

By defining safety and performance benchmarks, this standard supports manufacturers and healthcare providers in selecting, configuring, and maintaining high-flow respiratory therapy equipment, thus protecting both patient and operator welfare.

Related Standards

For comprehensive compliance and to address different aspects of respiratory care, the following standards should be considered alongside SIST EN ISO 80601-2-90:2026:

• ISO 80601-2-12: Critical care ventilators with high-flow therapy modes.
• ISO 80601-2-13: Ventilators and accessories for anaesthetic applications.
• ISO 80601-2-72: Ventilators for ventilator-dependent patients in the homecare environment.
• ISO 5356-1 / ISO 5367 / ISO 5359: Connectors, breathing sets, and hoses for respiratory devices.
• IEC 60601-1 Series: General safety requirements for medical electrical equipment.
• ISO 80601-2-74: Respiratory humidifying equipment.
• ISO 18562-1: Biocompatibility evaluation of breathing gas pathways.
• ISO 20417: Information supplied by the manufacturer for medical devices.

Referencing these related standards ensures a holistic approach to regulatory compliance, device interoperability, and patient safety in the use of respiratory high-flow therapy equipment.