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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 1-145
Standard
ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
Scope/Abstract
This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. 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 and ventilator breathing system.

NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.
Extent of Recognition
Complete standard
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.
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI COVID-19 Emergency Guidance for the design of ventilator, resuscitator, CPAP/BiPAP systems is available at https://www.aami.org/news-resources/covid-19-updates/covid_cr. Check back frequently for the latest version as these are living documents that evolve with experience.
FDA Technical Contacts
 Sandy Weininger
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2582
  sandy.weininger@fda.hhs.gov
 James J. Lee
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-8463
  James.J.Lee@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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