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ISO 80601:2023
ISO 80601:2023 Medical electrical equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
CDN $390.00
Description
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.
Edition
2
Published Date
2023-06-30
Status
PUBLISHED
Pages
142
Language
English
Format
Secure PDF
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Abstract
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.
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