NF EN ISO 8835-4

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Standards
NF EN ISO 8835-4

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.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2005

Number of pages

31 p.

Reference

NF EN ISO 8835-4

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

Classification index

S95-117-4

Print number

2 - 01/07/2006

International kinship

ISO 8835-4:2004

European kinship

EN ISO 8835-4:2004

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 (2)

NF EN 740

October 1998

Standard Cancelled

Anaesthetic workstations and their modules - Particular requirements

Le présent document s'applique aux évaporateurs, ventilateurs, systèmes respiratoires et d'évacuation ainsi qu'aux dispositifs de surveillance et d'alarme des systèmes d'anesthésie. Il donne les prescriptions complémentaires à celles de sécurité de la norme générale NF EN 60601-1 sur les appareils électromédicaux.

NF EN 740/A1

August 2004

Standard Cancelled

Anaesthetic workstations and their modules - Particular requirements

Le présent document ajoute à la notice d'utilisation une indication relative à un éventuel dysfonctionnement lié à l'alimentation en gaz médicaux.

Standard replaced by (1)

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.

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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