NF EN ISO 80601-2-72

NF EN ISO 80601-2-72

July 2023
Standard Current

Medical electrical equipment - Part 2-72 : particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

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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Main informations

Collections

National standards and national normative documents

Publication date

July 2023

Number of pages

154 p.

Reference

NF EN ISO 80601-2-72

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-186-2-72

Print number

1

International kinship

ISO 80601-2-72:2023

European kinship

EN ISO 80601-2-72:2023
Sumary
Medical electrical equipment - Part 2-72 : particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

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.

Replaced standards (1)
NF EN ISO 80601-2-72
November 2015
Standard Cancelled
Medical electrical equipment - Part 2-72 : particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

<p>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:</p> <ul> <li>intended for use in the home healthcare environment;</li> <li>intended for use by a lay operator;</li> <li>intended for use with patients who are dependent on mechanical ventilation for their life support.</li> </ul> <p>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.</p> <p>ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601‑1 and ISO/IEC 80601 series of standards.</p>

Table of contents
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  • 201.1 Domaine d'application, objet et normes connexes
  • 201.2 Références normatives
  • 201.3 Termes et définitions
  • 202 Perturbations électromagnétiques - Exigences et essais
  • 206 Aptitude à l'utilisation
  • 208 Exigences générales, essais et recommandations pour les systèmes d'alarme des appareils électromédicaux et des systèmes électromédicaux
  • 211 Exigences concernant les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile
  • Annexe C (informative) Guide pour les exigences de marquage et d'étiquetage des appareils EM et des systèmes EM
  • Annexe D (informative) Symboles des marquages
  • Annexe AA (informative) Recommandations particulières et justification
  • Annexe BB (informative) Exigences relatives à l'interface des données
  • Annexe CC (informative) Référence aux principes essentiels et recommandations d'étiquetage IMDRF
  • Annexe DD (informative) Référence aux principes essentiels
  • Annexe EE (informative) Référence aux exigences générales de sécurité et de performances
  • Index alphabétique des termes définis utilisés dans la présente norme particulière
  • Bibliographie
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