NF EN ISO 8835-4

NF EN ISO 8835-4

July 2009
Standard Cancelled

Inhalational anaesthesia systems - Part 4 : anaesthetic vapour delivery devices

For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows.Addition:ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13. ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers).The requirements of ISO 8835-4:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

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National standards and national normative documents

Publication date

July 2009

Number of pages

35 p.

Reference

NF EN ISO 8835-4

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-117-4

Print number

1 - 18/06/2009

International kinship

ISO 8835-4:2004

European kinship

EN ISO 8835-4:2009
Sumary
Inhalational anaesthesia systems - Part 4 : anaesthetic vapour delivery devices

For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows.

Addition:

ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.

ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers).

The requirements of ISO 8835-4:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

Replaced standards (1)
NF EN ISO 8835-4
January 2005
Standard Cancelled
Inhalational anaesthesia systems - Part 4 : anaesthetic vapour delivery devices

For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows. Addition: ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13. ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers). The requirements of ISO 8835-4:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

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
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences générales et exigences générales d'essai
    2
  • 5 Classification
    2
  • 6 Identification, marquage et documentation
    2
  • 7 Puissance absorbée
    4
  • 8 Catégories fondamentales de sécurité
    4
  • 9 Moyens de protection amovibles
    4
  • 10 Conditions d'environnement
    4
  • 11 Cet article n'est pas utilisé
    4
  • 12 Cet article n'est pas utilisé
    4
  • 13 Généralités
    4
  • 14 Exigences relatives à la classification
    5
  • 15 Limitation de la tension et/ou de l'énergie
    5
  • 16 Enveloppes et capots de protection
    5
  • 17 Séparation
    5
  • 18 Mise à la terre de protection, mise à la terre fonctionnelle et égalisation des potentiels
    5
  • 19 Courants de fuite permanents et courant auxiliaire patient
    5
  • 20 Tension de tenue
    5
  • 21 Résistance mécanique
    5
  • 22 Parties en mouvement
    5
  • 23 Surfaces, angles et arêtes
    5
  • 24 Stabilité en utilisation normale
    5
  • 25 Projection d'objets
    6
  • 26 Vibrations et bruit
    6
  • 27 Puissance pneumatique et hydraulique
    6
  • 28 Masses suspendues
    6
  • 29 Rayonnements X
    6
  • 30 Rayonnements alpha, bêta, gamma, neutroniques et d'autres particules
    6
  • 31 Rayonnements à micro-ondes
    6
  • 32 Rayonnements lumineux (y compris les rayonnements lasers)
    6
  • 33 Rayonnements infrarouges
    6
  • 34 Rayonnements ultraviolets
    6
  • 35 Énergie acoustique (y compris les ultrasons)
    6
  • 36 Compatibilité électromagnétique
    7
  • 37 Localisations et exigences fondamentales
    7
  • 38 Marquage et documents d'accompagnement
    7
  • 39 Exigences communes aux appareils de catégories AP et APG
    7
  • 40 Exigences et essais pour les appareils de catégorie AP, leurs parties et leurs composants
    7
  • 41 Exigences et essais pour les appareils de catégorie APG, leurs parties et leurs composants
    7
  • 42 Températures excessives
    7
  • 43 Prévention contre le feu
    7
  • 44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage, stérilisation, désinfection et compatibilité
    8
  • 45 Réservoirs et parties sous pression
    8
  • 46 Erreurs humaines
    8
  • 47 Charges électrostatiques
    8
  • 48 Biocompatibilité
    9
  • 49 Coupure de l'alimentation
    9
  • 50 Exactitude des caractéristiques de fonctionnement
    9
  • 51 Protection contre les caractéristiques de sortie présentant des risques
    9
  • 52 Fonctionnement anormal et conditions de défaut
    11
  • 53 Essais d'environnement
    11
  • 54 Généralités
    11
  • 55 Enveloppes et capots
    11
  • 56 Composants et ensembles
    11
  • 57 Parties principales, composants et montage
    11
  • 58 Mise à la terre de protection - Bornes et raccordements
    11
  • 59 Construction et montage
    11
  • 101 Exigences supplémentaires pour DAVA
    12
  • 102 Annexes de la IEC 60601-1:1988
    13
  • Annexe AA (informative) Justification
    14
  • Annexe BB (informative) Couleurs recommandées pour le code de couleur des dispositifs d'administration de vapeur anesthésique
    17
  • Annexe CC (normative) Essai d'inflammabilité des agents anesthésiques
    18
  • Bibliographie
    19
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