| 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 |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 1-105 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 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.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5895 | Continuous, Ventilator, Home Use | Class 2 | NOU |
| Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff, November 2014 Guidance on Medical Device Patient Labeling, April 2001 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 |