NF EN ISO 7376
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
ISO 7376:2003 specifies general requirements for laryngoscopes and critical dimensions for the handle and lamp of hook-on type laryngoscopes. It is applicable only to instruments with an electrical power source for illuminating the larynx, since electrical safety requirements may be more stringent for instruments connected to mains or external power packs. ISO 7376:2003 is not applicable to surgical instruments known by the same generic name. ISO 7376:2003 does not apply to:-- the blade form or handle design, except for general requirements and the interchangeability aspects of the connection between the blade and the handle;-- the measurement and specification of the lamp illumination intensity;-- flexible laryngoscopes, or laryngoscopes designed for surgery;-- laryngoscopes powered from mains electricity supply;-- laryngoscopes connected by light-transmitting cables to external light sources.Instruments connected by light guides to an external light source may be subject to other International Standards for endoscopes.
ISO 7376:2003 specifies general requirements for laryngoscopes and critical dimensions for the handle and lamp of hook-on type laryngoscopes.
It is applicable only to instruments with an electrical power source for illuminating the larynx, since electrical safety requirements may be more stringent for instruments connected to mains or external power packs.
ISO 7376:2003 is not applicable to surgical instruments known by the same generic name.
ISO 7376:2003 does not apply to:
- -- the blade form or handle design, except for general requirements and the interchangeability aspects of the connection between the blade and the handle;
- -- the measurement and specification of the lamp illumination intensity;
- -- flexible laryngoscopes, or laryngoscopes designed for surgery;
- -- laryngoscopes powered from mains electricity supply;
- -- laryngoscopes connected by light-transmitting cables to external light sources.
Instruments connected by light guides to an external light source may be subject to other International Standards for endoscopes.
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. Le présent document ne s'applique pas aux laryngoscopes souples.
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions1
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4 Exigences générales3
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4.1 Conception3
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4.2 Matériaux pour lames de laryngoscopes et laryngoscopes monoblocs3
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4.3 Exigences relatives à l'environnement3
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4.4 Source d'alimentation électrique interne3
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5 Exigences relatives aux performances3
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5.1 Mécanisme d'enclenchement de la lame et du manche3
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5.2 Mécanisme d'enclenchement du manche4
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5.3 Mécanisme d'enclenchement des lames6
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5.4 Enclenchement6
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5.5 Position de fonctionnement6
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5.6 Désenclenchement6
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6 Lampe pour lame traditionnelle8
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6.1 Contact de lampe et de culot de lampe8
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6.2 Filetages de lampes8
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7 Lampes pour laryngoscopes à éclairage par fibres optiques9
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8 Douilles pour lames traditionnelles10
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8.1 Dimensions et contact central10
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8.2 Filetages intérieurs10
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9 Nettoyage, désinfection et stérilisation10
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10 Marquage et étiquetage10
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11 Documents d'accompagnement11
- Annexe A (normative) Méthode d'essai relatives à la sécurité du contact de la lampe12
- Annexe B (normative) Marquages des lames13
- Annexe C (informative) Exposé des motifs14
- Bibliographie15
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