NF EN ISO 80601-2-72

Afnor EDITIONS
Standards
NF EN ISO 80601-2-72

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

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.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2015

Number of pages

112 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

International kinship

ISO 80601-2-72:2015

European kinship

EN ISO 80601-2-72:2015

Sumary

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 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.

Replaced standards (1)

NF EN ISO 10651-2

July 2009

Standard Cancelled

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2 : home care ventilators for ventilator-dependent patients

ISO 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training. ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988. ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators. ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients. The requirements of ISO 10651-2:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

Standard replaced by (1)

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.

Table of contents

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Avant-propos
201.1 Domaine d'application, objet et normes connexes
201.2 Références normatives
201.3 Termes et définitions
201.4 Exigences générales
201.5 Exigences générales relatives aux essais des APPAREILS EM
201.6 Classification des APPAREILS EM et des SYSTEMES EM
201.7 Identification, marquage et documentation des APPAREILS EM
201.8 Protection contre les DANGERS d'origine électrique provenant des APPAREILS EM
201.9 Protection contre les dangers mécaniques des APPAREILS EM et SYSTEMES EM
201.10 Protection contre les DANGERS dus aux rayonnements involontaires ou excessifs
201.11 Protection contre les températures excessives et les autres DANGERS
201.12 * Précision des commandes, des instruments et protection contre les caractéristiques de sortie présentant des risques
201.13 SITUATIONS DANGEREUSES et conditions de défaut
201.14 SYSTEMES ELECTROMEDICAUX PROGRAMMABLES (SEMP)
201.15 Construction de l'APPAREIL EM
201.16 SYSTEMES EM
201.17 Compatibilité électromagnétique des APPAREILS EM et des SYSTEMES EM
201.101 Raccordements des gaz
201.102 Exigences pour le VBS et ses ACCESSOIRES
201.103 * Respiration spontanée pendant une perte d'alimentation
201.104 * Formation
201.105 * Indication de la durée de fonctionnement
201.106 CONNEXION FONCTIONNELLE
201.107 Affichage des boucles
201.108 CABLES D'ALIMENTATION
201.109 Sécurité du VENTILATEUR
202 Perturbation électromagnétique - Exigences et essais
206 Aptitude à l'utilisation
208 Règles générales, essais et guides pour les systèmes d'alarme dans l'équipement électromédical et les systèmes électromédicaux
211 Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile
Annexe C (informative)Guide pour les exigences en matière de marquage et d'étiquetage des APPAREILS EM et SYSTEMES EM
Annexe D (informative)Symboles des marquages
Annexe AA (informative)Lignes directrices particulières et justifications
Annexe BB (informative)Exigences d'interface des données
Annexe CC (informative)Référence aux principes essentiels
Annexe DD (informative)Index alphabétique (selon l'anglais) des termes définis utilisés dans la présente norme particulière
Annexe Annexe ZA (informative) Relation entre le présent Document et les exigences essentielles de la Directive européenne 93/42/CEE
Bibliographie

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