NF EN ISO 8836
Suction catheters for use in the respiratory tract
This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
<p>ISO 8836:2014 specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.</p> <p>Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of ISO 8836:2014.</p>
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 *Exigences générales
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5 Matériaux
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6 Exigences relatives à la conception
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7 Exigences applicables aux sondes d'aspiration fournies stériles
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8 Emballage
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9 Informations fournies par le fabricant
- Annexe A Justification
- Annexe B Méthode d'essai de la sécurité de fixation
- Annexe C Mesurage du vide résiduel
- Annexe D *Méthode d'essai de l'étanchéité
- Annexe E Identification des phénomènes dangereux en vue de l'appréciation du risque
- Bibliographie
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