| 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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1-202
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| Standard | |
ISO 19223-3 First edition 2025-09
Lung ventilators and related equipment - Vocabulary and semantics - Part 3: Respiratory care |
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Scope/AbstractThis document defines terms for respiratory care.
This document is applicable:
- in respiratory high-flow therapy equipment standards;
- in sleep apnoea breathing therapy equipment standards;
- in sleep apnoea breathing therapy masks and accessories standards;
- in ventilatory support equipment 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;
- in electronic health records.
This document excludes mechanical ventilation (defined in ISO 19223:2019), high-frequency and jet ventilation (defined in ISO 19223-2:2025), negative pressure ventilation, liquid ventilation, and extracorporeal membrane oxygenation.
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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 Contacts
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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. |
