NF EN ISO 8835-5

NF EN ISO 8835-5

October 2009
Standard Cancelled

Inhalational anaesthesia systems - Part 5 : anaesthetic ventilators

ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator.ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB.The requirements of ISO 8835-5:2004 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.This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

October 2009

Number of pages

32 p.

Reference

NF EN ISO 8835-5

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-117-5

Print number

1 - 24/02/2010

International kinship

ISO 8835-5:2004

European kinship

EN ISO 8835-5:2009
Sumary
Inhalational anaesthesia systems - Part 5 : anaesthetic ventilators

ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator.

ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB.

The requirements of ISO 8835-5:2004 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.

This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.

Replaced standards (1)
NF EN ISO 8835-5
January 2005
Standard Cancelled
Inhalational anaesthesia systems - Part 5 : anaesthesic ventilators

ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator. ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB. The requirements of ISO 8835-5:2004 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. This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.

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
    3
  • 5 Classification
    3
  • 6 Identification, marquage et documents
    4
  • 7 Puissance absorbée
    6
  • 8 Catégories de sécurité fondamentales
    6
  • 9 Moyens de protection amovibles
    6
  • 10 Conditions d'environnement
    6
  • 11 Cet article n'est pas utilisé
    6
  • 12 Cet article n'est pas utilisé
    6
  • 13 Généralités
    6
  • 14 Exigences relatives à la classification
    6
  • 15 Limitation de la tension et/ou de l'énergie
    6
  • 16 Enveloppes et capots de protection
    6
  • 17 Séparation
    6
  • 18 Mise à la terre de protection, mise à la terre fonctionnelle et égalisation des potentiels
    7
  • 19 Courants de fuite permanents et courants auxiliaires du patient
    7
  • 20 Rigidité diélectrique
    7
  • 21 Résistance mécanique
    7
  • 22 Parties en mouvement
    7
  • 23 Surfaces, angles et arêtes
    7
  • 24 Stabilité en utilisation normale
    7
  • 25 Projections d'objets
    7
  • 26 Vibrations et bruit
    7
  • 27 Puissance pneumatique et hydraulique
    7
  • 28 Masses suspendues
    7
  • 29 Rayonnements X
    8
  • 30 Rayonnements alpha, bêta, gamma, neutroniques et d'autres particules
    8
  • 31 Rayonnements à micro-ondes
    8
  • 32 Rayonnements lumineux (y compris les lasers)
    8
  • 33 Rayonnements infrarouges
    8
  • 34 Rayonnements ultraviolets
    8
  • 35 Énergie acoustique (y compris les ultrasons)
    8
  • 36 Compatibilité électromagnétique
    8
  • 37 Localisations et exigences fondamentales
    8
  • 38 Marquage et documents d'accompagnement
    8
  • 39 Exigences communes aux appareils de catégories AP et APG
    8
  • 40 Exigences et essais pour les appareils de catégorie AP, leurs parties et leurs composants
    9
  • 41 Exigences et essais pour les appareils de catégorie APG, leurs parties et leurs composants
    9
  • 42 Températures excessives
    9
  • 43 Prévention contre le feu
    9
  • 44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage, stérilisation, désinfection et compatibilité
    9
  • 45 Réservoir et parties sous pression
    10
  • 46 Erreurs humaines
    10
  • 47 Charges électrostatiques
    10
  • 48 Biocompatibilité
    10
  • 49 Coupure de l'alimentation
    10
  • 50 Précision des caractéristiques de fonctionnement
    11
  • 51 Protection contre les caractéristiques de sortie présentant des risques
    11
  • 52 Fonctionnement anormal et conditions de défaut
    11
  • 53 Essais d'environnement
    11
  • 54 Généralités
    11
  • 55 Enveloppes et capots
    12
  • 56 Composants et ensembles
    12
  • 57 Parties principales, composants et montage
    12
  • 58 Mise à la terre de protection - Bornes et raccordements
    12
  • 59 Construction et montage
    12
  • 101 Exigences supplémentaires pour ventilateurs d'anesthésie
    12
  • 102 Annexes de la IEC 60601-1:1998
    13
  • Annexe AA (informative) Justification
    14
  • Annexe BB (normative) Essai d'inflammabilité des agents anesthésiques
    15
  • Bibliographie
    16
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ