NF EN ISO 7376

NF EN ISO 7376

September 2020
Standard Current

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation

This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible blades, with internal battery-operated power sources, used for illuminating the larynx during intubation. It also specifies critical dimensions for those handles and laryngoscope blades with interchangeable hook‐on fittings. It is not applicable to the following: — flexible laryngoscopes; — laryngoscopes designed for surgery; — laryngoscopes powered from mains electricity supply; — laryngoscopes connected by light‐transmitting cables to external light sources; — video laryngoscopes designed to work with an external, integral or attached video system.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2020

Number of pages

26 p.

Reference

NF EN ISO 7376

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-122

Print number

1

International kinship

ISO 7376:2020

European kinship

EN ISO 7376:2020
Sumary
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation

This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible blades, with internal battery-operated power sources, used for illuminating the larynx during intubation. It also specifies critical dimensions for those handles and laryngoscope blades with interchangeable hook‐on fittings.

It is not applicable to the following:

— flexible laryngoscopes;

— laryngoscopes designed for surgery;

— laryngoscopes powered from mains electricity supply;

— laryngoscopes connected by light‐transmitting cables to external light sources;

— video laryngoscopes designed to work with an external, integral or attached video system.

Replaced standards (1)
NF EN ISO 7376
November 2009
Standard Cancelled
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation

Le présent document donne des spécifications des laryngoscopes pour intubation trachéale, et particulièrement les dimensions critiques du mécanisme d'enclenchement lame-manche et des douilles de lampes. Il ne s'applique pas à tous les laryngoscopes et en particulier, aux laryngoscopes souples. Le présent document entre dans le cadre de la Directive 93/42/CEE sur les dispositifs médicaux.

Table of contents
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  • Avant-propos
  • 1 *Domaine d'application
  • 2 Références normatives
  • 3 *Termes et définitions
  • 4 Exigences générales
  • 5 Matériaux
  • 6 Exigences relatives à la conception
  • 7 Exigences de performance
  • 8 Nettoyage, désinfection et stérilisation
  • 9 Informations fournies par le fabricant
  • Annexe B (normative) Méthode d'essai relative à l'éclairage, à la rigidité et à la résistance
  • Annexe A (informative) Justifications
  • Annexe C (informative) Termes courants désignant les parties d'une lame de laryngoscope
  • Bibliographie
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