| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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1-105
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| Standard | (Included in ASCA pilot) |
ISO 80601-2-72 First edition 2015-04-11
Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
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Scope/AbstractISO 80601-2-72:2015 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:
- intended for use in the home healthcare environment;
- intended for use by a lay operator;
- intended for use with patients who are dependent on mechanical ventilation for their life support.
ISO 80601-2-72:2015 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. |
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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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5895 |
Continuous, Ventilator, Home Use |
Class 2 |
NOU |
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Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff, Issued November 2014.
3. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.
4. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff, Issued May 2005.
5. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff, Issued April 2016.
6. Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff, Issued April 2001.
7. 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.
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. |
