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ONORM EN ISO 19223:2021
Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)
This document establishes a vocabulary of terms and semantics for all areas of ventilation care including mechanical ventilation, such as intensive ventilation, anesthesia ventilation, rescue and transport ventilation, and home ventilation, including sleep apnea breathing therapy devices. It applies to: - standards for ventilators and respiratory therapy devices, - standards on medical informatics, - the labeling of medical electrical equipment and medical electrical systems, - instructions for use and accompanying documents for medical electrical devices and medical electrical systems, - the interoperability of medical electrical devices and medical electrical systems, and - electronic health records. This document shall also apply to accessories for which the manufacturer provides for connection to a respiratory system of the ventilator or a ventilator for which the characteristics of these accessories indicate the safety or essential performance characteristics of the Beat ...
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