NF EN ISO 8836
Suction catheters for use in the respiratory tract
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. 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.
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.
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>ISO 8836:2007 specifies requirements for suction catheters made of plastic materials and intended for use in suction of the respiratory tract.</p> <p>Specialized suction catheters, e.g. those with more than one lumen and suction catheters without a terminal orifice, are excluded from the scope of this International Standard.</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 8836:2007.</p>
<p>This document specifies dimensions and requirements for both <i>open</i> and <i>closed suction catheters</i> made of flexible materials and intended for use in suctioning of the respiratory tract.</p> <p><i>Suction catheters</i> intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.</p> <p>NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991<sup>[4]</sup>.</p>
- Avant-propos
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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 applicables aux sondes d'aspiration ouvertes et fermées
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5 Exigences spécifiques applicables aux sondes d'aspiration ouvertes et fermées
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6 Matériaux
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7 *Conception
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8 Exigences applicables aux performances
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9 Exigences applicables aux sondes d'aspiration fournies stériles
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10 Marquage
- Annexe B (normative) Méthode d'essai de la sécurité de fixation
- Annexe A (informative) Justifications
- Annexe C (normative) Mesurage du vide résiduel
- Annexe D (normative) Méthode d'essai de l'étanchéité
- Annexe E (informative) Identification des phénomènes dangereux pour l'appréciation du risque
- Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 93/42/CEE
- Bibliographie
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