| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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1-201
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| Standard | |
ISO 19223-2 First edition 2025-04
Lung ventilators and related equipment - Vocabulary and semantics - Part 2: High frequency and jet ventilation. |
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Scope/AbstractThis document defines terms for:
- high-frequency oscillatory ventilation (HFOV);
- percussive ventilation, including high-frequency percussive ventilation (HFPV);
- jet ventilation, including high frequency jet ventilation (HFJV);
- modes that combine high-frequency and physiological-rate ventilation.
It is applicable:
- in lung ventilator and breathing-therapy device standards,
- in health informatics standards,
- for labelling on medical electrical equipment and medical electrical systems,
- in medical electrical equipment and medical electrical system instructions for use and accompanying documents,
- for medical electrical equipment and medical electrical systems interoperability, and
- in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator or ventilator breathing system.
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
