DIN EN ISO 19223 2021-09 PDF

Full title and description

STB / DIN EN ISO 19223:2021-09 — Lung ventilators and related equipment — Vocabulary and semantics. This document is the German (DIN) adoption of EN ISO 19223:2021, which takes over the international ISO 19223:2019 terminology and semantic definitions for mechanical ventilators and related respiratory-care equipment.

Abstract

ISO 19223 establishes a standardized vocabulary, precise definitions and semantic conventions for terms used across mechanical ventilation (including intensive care, anaesthesia, emergency/transport, home care and sleep-apnoea therapy). It is intended to remove ambiguity in mode names, settings and ventilator–patient interactions to support safe labeling, instructions for use, device interoperability and information exchange between manufacturers, clinicians and health‑IT systems.

General information

• Status: Current / adopted national standard (DIN adoption of EN ISO 19223:2021).
• Publication date: 2021-09-01 (DIN publication / German-language version: September 2021).
• Publisher: Deutsches Institut für Normung (DIN) as DIN adoption of EN ISO 19223; original international publication: ISO (ISO 19223:2019).
• ICS / categories: 01.040.11 (Health care technology — Vocabularies); 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: DIN EN ISO 19223:2021-09 (adoption of EN ISO 19223:2021); original ISO reference ISO 19223:2019 (Edition 1, July 2019).
• Number of pages: 174 pages (DIN-published edition / common page count reported by DIN and standards resellers).

Scope

The standard defines terms, symbols and semantic relationships needed to describe ventilator functions, breath types, modes, timing/phase concepts, pressure/flow/volume terminology, baseline/PEEP concepts, alarms and related items for all fields of respiratory care. It is applicable to ventilator standards, medical device labeling and instructions, health‑IT data interchange and interoperability for ventilator-related data. The document focuses on consistent definitions rather than performance or safety test requirements.

Key topics and requirements

• Standardized terminology for general artificial‑ventilation concepts (definitions and relationships).
• Breath-type classification and breath initiation/termination semantics.
• Time, phase and cycle terminology (timing relationships used to describe breaths and modes).
• Rate terminology (primary and secondary rate concepts).
• Pressure, baseline and PEEP definitions (including baseline concepts and safety-limit language).
• Flow and volume terminology and related measurement semantics.
• Mode and bi‑level nomenclature, including variables used to specify and distinguish modes.
• Alarm and safety‑limit vocabulary to support unambiguous documentation and labeling.
• Informative annexes with rationales, classification tables, illustrations and implementation guidance.

Typical use and users

Primary users are medical device and ventilator manufacturers (for mode naming, UI labels and interoperability), clinical engineers and biomedical teams (for device integration and alarm interpretation), clinicians and respiratory therapists (for shared understanding of settings and modes) and health‑IT implementers (for mapping ventilator data into EHRs and interoperability standards). Regulators and standards authors use the vocabulary to harmonize labeling and normative language.

Related standards

ISO 19223 is a terminology/semantics document and complements ventilator safety and performance standards (for example the ISO/IEC medical electrical equipment family such as ISO 80601-2-12 for critical‑care ventilators and the IEC/ISO 60601 series for medical electrical equipment). It is intended to be used alongside device‑specific performance and safety standards when writing labels, instructions and interoperability profiles.

Keywords

lung ventilators; mechanical ventilation; vocabulary; semantics; ventilation modes; breath terminology; PEEP; baseline pressure; flow; volume; alarms; device labeling; interoperability.

FAQ

Q: What is this standard?

A: ISO 19223 (adopted as DIN EN ISO 19223:2021-09 in Germany) is a standardized vocabulary and semantics document for lung ventilators and related respiratory-care equipment. It provides agreed definitions and relationships so different stakeholders use the same language when describing ventilator functions and modes.

Q: What does it cover?

A: It covers terms, definitions, symbols and semantic conventions for breaths, modes, timing/phase concepts, pressure/flow/volume terminology, baseline/PEEP, alarms and related items; it also includes informative annexes with examples and implementation guidance. It does not replace device safety/performance test standards — it complements them.

Q: Who typically uses it?

A: Ventilator and medical‑device manufacturers (nomenclature, UI, labeling), clinical engineers and biomedical teams, clinicians and respiratory therapists (to reduce ambiguity), health‑IT/EHR implementers (data mapping) and regulators/standards writers.

Q: Is it current or superseded?

A: The original international text is ISO 19223:2019 (Edition 1, July 2019). The EN/DIN adoption was published in 2021 (DIN EN ISO 19223:2021-09) and is listed as the current adopted edition in national catalogs; check with your national standards body for the absolute latest confirmation or any amendments.

Q: Is it part of a series?

A: ISO 19223 is a stand‑alone vocabulary/semantics standard but is intended to be used alongside device‑specific standards in the ISO/IEC medical‑equipment family (for example ISO 80601 series and the IEC 60601 series) that address safety and performance.

Q: What are the key keywords?

A: Keywords include lung ventilators, mechanical ventilation, vocabulary, semantics, ventilation modes, breath terminology, PEEP, pressure, flow, volume, alarms, interoperability and device labeling.