NF EN ISO 8835-2

NF EN ISO 8835-2

July 2009
Standard Cancelled

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.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2009

Number of pages

35 p.

Reference

NF EN ISO 8835-2

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-117-2

Print number

1 - 18/06/2009

International kinship

ISO 8835-2:2007

European kinship

EN ISO 8835-2:2009
Sumary
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.

Standard replaced by (1)
Standard Current
Medical electrical equipment - Part 2-13 : particular requirements for basic safety and essential performance of an anaesthetic workstation

<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>

Table of contents
View the extract
  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Généralités
    3
  • 4.1 Matériaux
    3
  • 4.2 Emballage des éléments d'un système respiratoire d'anesthésie
    3
  • 4.3 Exigences électriques
    3
  • 4.4 Méthodes d'essai de remplacement
    4
  • 5 Orifices de raccordement
    4
  • 5.1 Orifice de raccordement côté "patient"
    4
  • 5.2 Pièce en Y
    4
  • 5.3 Orifice de raccordement d'évacuation
    4
  • 5.4 Valves d'évacuation de non-réinspiration interchangeables
    5
  • 5.5 Orifice de raccordement pour ballon
    5
  • 5.6 Orifice de raccordement d'un ventilateur d'anesthésie
    5
  • 5.7 Orifices de raccordement des éléments interchangeables d'un système respiratoire d'anesthésie
    5
  • 5.8 Orifices de raccordement inspiratoires et expiratoires d'un montage circulaire avec absorbeur interchangeable
    5
  • 5.9 Autres orifices de raccordement
    5
  • 6 Sélecteur ballon réservoir/ventilateur d'anesthésie
    6
  • 7 Système respiratoire d'anesthésie complet fourni prémonté ou fourni monté selon les instructions du fabricant
    6
  • 7.1 Étanchéité
    6
  • 7.2 Caractéristiques de pression/débit inspiratoire et expiratoire
    6
  • 8 Éléments interchangeables d'un système respiratoire d'anesthésie - Valves d'évacuation
    6
  • 8.1 Orientation des mouvements de commande
    6
  • 8.2 Caractéristiques de pression/débit
    6
  • 8.3 Pression d'ouverture
    7
  • 8.4 Étanchéité
    7
  • 9 Montages circulaires avec absorbeur
    7
  • 9.1 Montage
    7
  • 9.2 Mécanisme de contournement de l'absorbeur
    7
  • 9.3 Caractéristiques de pression/débit
    8
  • 9.4 Valves inspiratoires et expiratoires
    8
  • 10 Surveillance et limitation de la pression
    8
  • 10.1 Surveillance de la pression
    8
  • 10.2 Dispositif de limitation de la pression
    9
  • 11 Emplacement des éléments d'un système respiratoire d'anesthésie comportant un montage circulaire avec absorbeur (tel que défini en 3.3)
    9
  • 11.1 Valve d'évacuation
    9
  • 11.2 Orifice de raccordement pour ballon
    9
  • 11.3 Orifice d'admission de gaz frais
    9
  • 11.4 Valves inspiratoires et expiratoires
    9
  • 12 Marquage
    9
  • 12.1 Marquage des systèmes respiratoires d'anesthésie complets et de leurs éléments
    9
  • 12.2 Marquage des emballages
    11
  • 13 Informations à fournir par le fabricant ou le fournisseur
    11
  • 13.1 Généralités
    11
  • 13.2 Pour les systèmes respiratoires d'anesthésie fournis complets
    12
  • 13.3 Pour les éléments d'un système respiratoire d'anesthésie
    12
  • Annexe A (normative) Montages et méthodes d'essai types
    14
  • Annexe B (informative) Exposé des motifs
    19
  • Annexe C (informative) Aspects environnementaux
    21
  • Annexe D (normative) Exigences antistatiques
    22
  • Bibliographie
    23
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