NF EN ISO 8835-2
Inhalational anaesthesia systems - Part 2 : anaesthetic breathing systems
ISO 8835-2:2007 specifies requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions. ISO 8835-2:2007 also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator.
ISO 8835-2:2007 specifies requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions.
ISO 8835-2:2007 also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator.
<p>ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. </p> <p>ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:</p> <ul> <li> anaesthetic gas delivery system;</li> <li> anaesthetic breathing system;</li> <li> anaesthetic gas scavenging system;</li> <li> anaesthetic vapour delivery system;</li> <li> anaesthetic ventilator;</li> <li> monitoring equipment;</li> <li> alarm system;</li> <li> protection device.</li> </ul> <p>ISO/IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.</p> <p>If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components, as relevant.</p> <p>Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.</p> <p>ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.</p>
- Avant-proposv
- Introductionvi
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions2
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4 Généralités3
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4.1 Matériaux3
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4.2 Emballage des éléments d'un système respiratoire d'anesthésie3
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4.3 Exigences électriques3
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4.4 Méthodes d'essai de remplacement4
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5 Orifices de raccordement4
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5.1 Orifice de raccordement côté "patient"4
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5.2 Pièce en Y4
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5.3 Orifice de raccordement d'évacuation4
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5.4 Valves d'évacuation de non-réinspiration interchangeables5
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5.5 Orifice de raccordement pour ballon5
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5.6 Orifice de raccordement d'un ventilateur d'anesthésie5
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5.7 Orifices de raccordement des éléments interchangeables d'un système respiratoire d'anesthésie5
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5.8 Orifices de raccordement inspiratoires et expiratoires d'un montage circulaire avec absorbeur interchangeable5
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5.9 Autres orifices de raccordement5
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6 Sélecteur ballon réservoir/ventilateur d'anesthésie6
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7 Système respiratoire d'anesthésie complet fourni prémonté ou fourni monté selon les instructions du fabricant6
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7.1 Étanchéité6
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7.2 Caractéristiques de pression/débit inspiratoire et expiratoire6
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8 Éléments interchangeables d'un système respiratoire d'anesthésie - Valves d'évacuation6
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8.1 Orientation des mouvements de commande6
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8.2 Caractéristiques de pression/débit6
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8.3 Pression d'ouverture7
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8.4 Étanchéité7
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9 Montages circulaires avec absorbeur7
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9.1 Montage7
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9.2 Mécanisme de contournement de l'absorbeur7
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9.3 Caractéristiques de pression/débit8
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9.4 Valves inspiratoires et expiratoires8
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10 Surveillance et limitation de la pression8
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10.1 Surveillance de la pression8
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10.2 Dispositif de limitation de la pression9
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11 Emplacement des éléments d'un système respiratoire d'anesthésie comportant un montage circulaire avec absorbeur (tel que défini en 3.3)9
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11.1 Valve d'évacuation9
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11.2 Orifice de raccordement pour ballon9
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11.3 Orifice d'admission de gaz frais9
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11.4 Valves inspiratoires et expiratoires9
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12 Marquage9
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12.1 Marquage des systèmes respiratoires d'anesthésie complets et de leurs éléments9
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12.2 Marquage des emballages11
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13 Informations à fournir par le fabricant ou le fournisseur11
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13.1 Généralités11
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13.2 Pour les systèmes respiratoires d'anesthésie fournis complets12
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13.3 Pour les éléments d'un système respiratoire d'anesthésie12
- Annexe A (normative) Montages et méthodes d'essai types14
- Annexe B (informative) Exposé des motifs19
- Annexe C (informative) Aspects environnementaux21
- Annexe D (normative) Exigences antistatiques22
- Bibliographie23
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