EN ISO 19223:2021 PDF

Overview

EN ISO 19223:2021 (ISO 19223:2019) defines a standardized vocabulary and semantics for lung ventilators and related equipment. Its purpose is to remove ambiguity in the language used for mechanical ventilation across clinical domains - intensive care, anaesthesia, emergency and transport, home care and sleep-apnoea therapy - and to support consistent communication between manufacturers, clinicians, health‑IT systems and regulators.

This standard is primarily a terminology document: it establishes precise definitions, relationships and conventions so that ventilator settings, modes and ventilator–patient interactions can be described, recorded and exchanged unambiguously.

Key topics and technical scope

The document organizes and standardizes terms across major technical areas (see main clause headings):

• General artificial‑ventilation terminology
• Breath terminology and types of breaths
• Lung inflation terminology
• Time, phase and cycle terminology
• Rate terminology (primary and secondary rate concepts)
• Pressure terminology (including baseline and PEEP concepts)
• Flow and volume terminology
• Initiation and termination of breaths
• Mode and bi‑level terminology
• Safety limits and alarm terminology
• Gas port and accessory terminology

It also includes informative annexes offering rationales, illustrations, classification tables, implementation guidance and an alphabetized index of defined terms. The standard provides semantics essential for device labelling, instructions for use, interoperability and electronic health records.

Note: the standard intentionally excludes many highly specialized areas (e.g., specific breathing‑therapy equipment terms, physiologic closed‑loop, high‑frequency or negative‑pressure ventilation, liquid ventilation and extracorporeal gas exchange), except where needed to define boundaries.

Practical applications - who uses this standard

• Medical device manufacturers - for consistent product specifications, UI labels and mode naming.
• Clinical engineers and biomed teams - for safe device integration, maintenance and alarm interpretation.
• Clinicians and respiratory therapists - to reduce misinterpretation of ventilator settings across platforms.
• Health‑IT and interoperability implementers - for mapping ventilator data into electronic health records (EHRs) and data exchange standards.
• Standards writers and regulators - to harmonize device standards, labelling and conformity assessments.
• Researchers, incident investigators and vigilance/reporting systems - for precise event description, forensic analysis and data aggregation.

Related standards and governance

• Prepared by ISO/TC 121 (Anaesthetic and respiratory equipment) and adopted as EN ISO 19223:2021 by CEN/TC 215.
• Works alongside health informatics and medical electrical equipment standards to enable safe ventilator interoperability and consistent clinical documentation.

Keywords: ISO 19223, lung ventilators standard, ventilator vocabulary, ventilation terminology, mechanical ventilation, ventilator interoperability, PEEP, breath terminology, medical device labelling.