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SSH EN ISO 80601-2-72:2015

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)

Oct 27, 2016

General information

60.60     Oct 27, 2016

DPS

DPS/KT 215

European Norm

11.040.10  

English  

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Scope

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.
ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601‑1 and ISO/IEC 80601 series of standards.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

NOW

PUBLISHED
SSH EN ISO 80601-2-72:2015
60.60 Standard published
Oct 27, 2016

REVISED BY

IN_DEVELOPMENT
prSSH EN ISO 80601-2-72:2023

Related project

Adopted from EN ISO 80601-2-72:2015

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