Tracked Changes. Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
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Standard number:
BS EN ISO 80601-2-72:2023 - TC
Pages:
390
Released:
2023-07-25
ISBN:
978 0 539 27889 7
Status:
Tracked Changes
DESCRIPTION
BS EN ISO 80601-2-72:2023 - TC
This standard BS EN ISO 80601-2-72:2023 - TC Tracked Changes. Medical electrical equipment is classified in these ICS categories:
11.040.10 Anaesthetic, respiratory and reanimation equipment
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.
