ISO 19223-2:2025

Overview

ISO 19223-2:2025 establishes a comprehensive vocabulary and semantics for lung ventilators and related equipment, focusing specifically on high-frequency and jet ventilation. Developed by the International Organization for Standardization (ISO), this standard harmonizes terminology used in various high-frequency ventilation modes to promote clarity, safety, and interoperability across medical devices and healthcare informatics systems. The document is vital for manufacturers, clinicians, and software developers working with lung ventilators and associated accessories, ensuring consistent language in documentation, labelling, electronic health records, and regulatory compliance.

Key Topics

• High-Frequency Oscillatory Ventilation (HFOV): Terms related to delivery of ventilation at frequencies exceeding 150 inflations per minute, typically superimposed onto a defined mean airway pressure.
• Jet Ventilation: Vocabulary for ventilation delivered by a high-velocity gas jet through a small-diameter cannula, including both standard and high-frequency jet ventilation (HFJV).
• Percussive Ventilation: Definitions for techniques delivering rapid, pressure-based pulses, including high-frequency percussive ventilation (HFPV) and burst modes.
• Combined and Superimposed Modes: Standardized terms for ventilation modes that combine high-frequency and physiological-rate ventilatory patterns.
• Pressure, Flow, and Volume: Consistent definitions for key parameters such as HFV frequency, I:E ratio, jet flow, HFV volume, and pressure amplitude.
• Breathing-therapy Device Accessories: Clarifies terminology usage for accessories that affect safety and performance when connected to ventilator systems.

Applications

ISO 19223-2:2025 supports a wide range of practical applications in the field of respiratory care and medical device manufacturing:

• Product Development and Labelling: Enables manufacturers to use harmonized terminology on ventilator systems, accessories, and medical device labelling, meeting international standards requirements.
• Clinical Documentation and Training: Facilitates accurate documentation in medical electrical equipment instructions, training materials, and clinical protocols, reducing risk of misunderstanding and error.
• Interoperability and Health Informatics: Supports uniform data exchange and device connectivity through consistent language for electronic health records, integration with medical software, and device-to-device communication.
• Regulatory Compliance: Assists stakeholders in meeting regulatory obligations by providing standardized terms for safety and performance reporting, risk management, and adverse event reporting systems.
• Research and Critical Event Reporting: Promotes reliability and comparability in research, description of critical events, and forensic analyses by offering universally recognized definitions.

Related Standards

Integrating ISO 19223-2:2025 with other international standards strengthens the overall framework for anaesthetic and respiratory equipment:

• ISO 19223:2019: The primary part of the vocabulary and semantics series for lung ventilators and related equipment.
• ISO 4135:2022: General vocabulary for anaesthetic and respiratory equipment.
• ISO 704:2022: Guidelines for terminological work and principles.
• ISO 10241-1:2011: Requirements for terminological entries in standards.
• IEC 60601-1:2005+AMD1:2012: Requirements for basic safety and essential performance of medical electrical equipment.

Summary

By adopting ISO 19223-2:2025, stakeholders enhance the clarity, safety, and interoperability of high-frequency and jet ventilation systems. The use of standardized terminology brings practical benefits throughout the lifecycle of ventilators - from design to deployment, clinical application, and reporting - ensuring global consistency and optimal patient care in respiratory therapy.