ISO 80601-2-72:2023
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
Abstract
ISO/IEC 80601-2-72:2023 This document 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; and
- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
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.
- intended for use in the home healthcare environment;
- intended for use by a lay operator; and
- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
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.
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Additional information
| Publication type | International Standard |
|---|---|
| Publication date | 2023-06-30 |
| Edition | 2.0 |
| Available language(s) | English, French |
| TC/SC | TC 62/SC 62D - Particular medical equipment, software, and systemsrss |
| ICS | 11.040.10 - Anaesthetic, respiratory and reanimation equipment |
| Stability date | 2027 |
| Pages | 153 |
| File size | 2255 KB |
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