NF EN ISO 18778

NF EN ISO 18778

October 2022
Standard Current

Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:—    intended for use in the home healthcare environment;—    intended for use by a lay operator;—    intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and—    intended for transit-operable use.NOTE       An infant cardiorespiratory monitor can also be used in professional health care facilities.This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.EXAMPLE        probes, cables distributed alarm system

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Main informations

Collections

National standards and national normative documents

Publication date

October 2022

Number of pages

68 p.

Reference

NF EN ISO 18778

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-187

Print number

1

International kinship

ISO 18778:2022

European kinship

EN ISO 18778:2022
Sumary
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:

—    intended for use in the home healthcare environment;

—    intended for use by a lay operator;

—    intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and

—    intended for transit-operable use.

NOTE       An infant cardiorespiratory monitor can also be used in professional health care facilities.

This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.

EXAMPLE        probes, cables distributed alarm system

Replaced standards (1)
NF EN ISO 18778
July 2009
Standard Cancelled
Respiratory equipment - Infant monitors - Particular requirements

ISO 18778:2005 specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision. ISO 18778:2005 also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. It does not apply to monitors intended for use in health care facilities/institutions.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Exigences générales relatives aux essais des appareils EM
  • 6 Classification des appareils EM et des systèmes EM
  • 7 Identification, marquage et documentation des appareils EM
  • 8 Protection contre les dangers d'origine électrique des appareils EM
  • 9 Protection contre les dangers mécaniques des appareils EM et des systèmes EM
  • 10 Protection contre les dangers dus aux rayonnements involontaires ou excessifs
  • 11 Protection contre les températures excessives et les autres dangers
  • 12 Précision des commandes et des instruments et protection contre les caractéristiques de sortie présentant des risques
  • 13 Situations dangereuses et conditions de défaut pour les appareils EM
  • 14 Systèmes électromédicaux programmables (SEMP)
  • 15 Construction d'un appareil EM
  • 16 Systèmes EM
  • 17 Compatibilité électromagnétique des appareils EM et des systèmes EM
  • 18 Exigences relatives aux accessoires
  • 19 Formation
  • 20 Connexion fonctionnelle
  • 21 Perturbations électromagnétiques - Exigences et essais
  • 22 Aptitude à l'utilisation
  • 23 Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux
  • 2 4 Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l' environnement des soins à domicile
  • Annexe A (informative) Recommandations générales et justifications
  • Annexe B (informative) Ordre des essais
  • Annexe C (informative) Guide pour le marquage et exigences d'étiquetage pour les appareils EM et les systèmes EM
  • Annexe D (informative) Symboles des marquages
  • Annexe E (informative) Exemples de connexion du dispositif de mesure (DM) pour la mesure du courant de fuite patient et du courant auxiliaire patient
  • Annexe F (informative) Circuits d'alimentation de mesure adaptés
  • Annexe G (informative) Protection contre les dangers d'inflammation des mélanges anesthésiques inflammables
  • Annexe H (informative) Structure de SEMP, cycle de développement SEMP et documentation
  • Annexe I (informative) Aspects des Systèmes EM
  • Annexe J (informative) Étude des chemins d'isolation
  • Annexe K (informative) Schémas simplifiés de courant de fuite patient
  • Annexe L (informative) Fils de bobinage isolés pour utilisation sans isolation intercalée
  • Annexe M (informative) Réduction des degrés de pollution
  • Annexe N (informative) Exigences concernant l'interface des données
  • Annexe O (informative) Considérations pour l'étude des performances cliniques
  • Annexe P (informative) Référence aux principes essentiels et recommandations d'étiquetage de l'IMDRF
  • Annexe Q (informative) Référence aux principes essentiels
  • Annexe R (informative) Référence aux exigences générales de sécurité et de performances
  • Terminologie - Index alphabétique des termes définis
  • Bibliographie
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