NF EN ISO 8835-3

NF EN ISO 8835-3

October 2009
Standard Cancelled

Inhalational anaesthesia systems - Part 3 : transfer and receiving systems of active anaesthetic gas scavenging systems

ISO 8835-3:2007 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure).ISO 8835-3:2007 also specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2009

Number of pages

35 p.

Reference

NF EN ISO 8835-3

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-117-3

Print number

1 - 11/02/2013

International kinship

ISO 8835-3:2007

European kinship

EN ISO 8835-3:2009
Sumary
Inhalational anaesthesia systems - Part 3 : transfer and receiving systems of active anaesthetic gas scavenging systems

ISO 8835-3:2007 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure).

ISO 8835-3:2007 also specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

Replaced standards (1)
NF EN ISO 8835-3
October 2007
Standard Cancelled
Inhalational anaesthesia systems - Part 3 : transfer and receiving systems of active anaesthetic gas scavenging systems

ISO 8835-3:2007 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure). ISO 8835-3:2007 also specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

Standard replaced by (1)
NF EN ISO 80601-2-13
April 2013
Standard Current
Medical electrical equipment - Part 2-13 : particular requirements for basic safety and essential performance of an anaesthetic workstation

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. 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: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system; anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device. 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. 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. 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. 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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences générales et méthodes d'essai alternatives
    4
  • 4.1 Matériaux
    4
  • 4.2 Dispositifs de décharge
    4
  • 4.3 Méthodes d'essai alternatives
    4
  • 5 Protection du patient et de l'environnement
    4
  • 5.1 Conditions normales de fonctionnement
    4
  • 5.2 Conditions de premier défaut
    5
  • 6 Raccords
    6
  • 7 Systèmes de transfert
    6
  • 7.1 Orifice d'entrée des systèmes de transfert
    6
  • 7.2 Orifice de sortie des systèmes de transfert
    6
  • 8 Systèmes de réception
    7
  • 8.1 Généralités
    7
  • 8.2 Orifice d'entrée des systèmes de réception
    7
  • 8.3 Orifice de sortie des systèmes de réception
    7
  • 8.4 Indicateur visuel
    7
  • 8.5 Filtre à particules
    8
  • 8.6 Tuyaux de réception
    8
  • 9 Résistance au débit extrait
    8
  • 9.1 Systèmes de réception et de transfert à faible débit
    8
  • 9.2 Systèmes de réception et de transfert à fort débit
    8
  • 10 Exigences électriques
    8
  • 11 Informations devant être fournies par le fabricant
    8
  • 12 Marquage
    9
  • 13 Code couleur
    9
  • Annexe A (informative) Montages et méthodes d'essai types utilisés dans les essais de mesure de la pression à l'orifice d'entrée d'un SEGA
    10
  • Annexe B (informative) Montage et méthode d'essai types utilisés dans les essais de limitation de la pression subatmosphérique
    14
  • Annexe C (informative) Montage et méthode d'essai types utilisés pour soumettre à essai le débit induit
    15
  • Annexe D (informative) Montage et méthode d'essai types utilisés pour les essais de résistance au débit extrait
    16
  • Annexe E (informative) Montage et méthode d'essai types utilisés dans les essais de dispersion
    18
  • Annexe F (informative) Exposé des motifs
    21
  • Annexe G (informative) Aspects environnementaux
    24
  • Bibliographie
    25
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