This document defines terms for:

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— high-frequency oscillatory ventilation (HFOV);

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— percussive ventilation, including high-frequency percussive ventilation (HFPV);

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— jet ventilation, including high frequency jet ventilation (HFJV);

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— modes that combine high-frequency and physiological-rate ventilation.

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It is applicable:

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— in lung ventilator and breathing-therapy device standards,

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— in health informatics standards,

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— for labelling on medical electrical equipment and medical electrical systems,

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— in medical electrical equipment and medical electrical system instructions for use and accompanying documents,

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— for medical electrical equipment and medical electrical systems interoperability, and

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— in electronic health records.

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This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilatorbreathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator or ventilatorbreathing system.

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NOTE This document can also be used for other applications relating to lungventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.

Product Details

Published:

04/01/2025

File Size:

1 file , 1 Byte

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus