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National standards and national normative documents

Publication date

May 2009

Number of pages

48 p.

Reference

NF EN 794-1+A2

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

Classification index

S95-118

Print number

1 - 13/05/2009

European kinship

EN 794-1+A2:2009

Sumary

Lung ventilators - Part 1 : particular requirements for critical care ventilators

Le présent document s'applique aux ventilateurs de soins intensifs. Ce document donne les prescriptions complémentaires à celles de sécurité de la norme générale NF EN 60601-1:1990 sur les appareils électromédicaux. Il donne les moyens de se conformer aux exigences des Directives "Dispositifs médicaux" 93/42/CE et "Machines" 2006/42/CE.

Replaced standards (2)

NF EN 794-1

September 1997

Standard Cancelled

Lung ventilators. Part 1 : particular requirements for critical care ventilators.

Le présent document s'applique aux ventilateurs de soins intensifs. Ce document donne les prescriptions complémentaires à celles de sécurité de la norme générale NF EN 60601-1:1990 sur les appareils électromédicaux.

NF EN 794-1/A1

April 2001

Standard Cancelled

Lung ventilators - Part 1 : particular requirements for critical care ventilators

Le présent document révise les exigences pour le reflux de gaz entre orifices d'entrée haute pression.

Standard replaced by (1)

NF EN ISO 80601-2-12

June 2011

Standard Cancelled

Medical electrical equipment - Part 2-12 : particular requirements for basic safety and essential performance of critical care ventilators

ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems 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 me equipment and to me systems, as relevant. ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6.

Table of contents

Avant-propos
5
Introduction
6
1 Domaine d'application
6
2 Références normatives
6
3 Terminologie et définitions
7
4 Prescriptions générales et prescriptions générales relatives aux essais
10
5 Classification
10
6 Identification, marquage et documentation
11
7 Puissance absorbée
14
8 Catégories fondamentales de sécurité
14
9 Moyens de protection amovibles
14
10 Conditions d'environnement
14
13 Généralités
15
14 Prescriptions relatives à la classification
15
15 Limitation de la tension et/ou de l'énergie
15
16 Enveloppes et capots de protection
15
17 Séparation
15
18 Mise à la terre de protection, mise à la terre fonctionnelle et égalisation des potentiels
16
19 Courants de fuite permanents et courant auxiliaire du patient
16
20 Tension de tenue
16
21 Résistance mécanique
16
22 Parties en mouvement
16
23 Surfaces, angles et arêtes
16
24 Stabilité en utilisation normale
16
25 Projections d'objets
16
26 Vibrations et bruit
16
27 Puissance pneumatique et hydraulique
17
28 Masses suspendues
17
29 Rayonnements X
17
30 Rayonnements alpha, bêta, gamma, neutroniques et d'autres particules
17
31 Rayonnements à micro-ondes
17
32 Rayonnements lumineux (y compris lasers)
17
33 Rayonnements infrarouges
17
34 Rayonnements ultraviolets
17
35 Énergie acoustique (y compris les ultrasons)
17
36 Compatibilité électromagnétique
18
37 Localisations et prescriptions fondamentales
18
38 Marquage et documents d'accompagnement
18
39 Prescriptions communes aux appareils de catégories AP et APG
18
40 Prescriptions et essais pour les appareils de catégorie AP, parties et composants de ceux-ci
18
41 Prescriptions et essais pour les appareils de catégorie APG, parties et composants de ceux-ci
18
42 Températures excessives
19
43 Prévention du feu
19
44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage, stérilisation, désinfection et compatibilité
19
45 Réservoir et parties sous pression
19
46 Erreurs humaines
20
47 Charges électrostatiques
20
48 Matériaux des parties appliquées en contact avec le corps du patient
20
49 Coupure de l'alimentation
20
50 Précision des caractéristiques de fonctionnement
20
51 Protection contre les caractéristiques de sortie présentant des risques
21
52 Fonctionnement anormal et conditions de défaut
26
53 Essais d'environnement
26
54 Généralités
26
55 Enveloppes et capots
26
56 Composants et ensembles
26
57 Parties reliées au réseau, composants et montage
30
58 Mise à la terre de protection - Bornes et raccordements
30
59 Construction et montage
30
Annexe AA (informative) Exposé des motifs
31
Annexe BB (normative) Lisibilité et visibilité des indications visuelles
35
Annexe CC (informative) Configuration-type d'un ventilateur
36
Annexe DD (informative) Bibliographie
38
Annexe EE (informative) Composants sonores des alarmes
39
Annexe FF (normative) Conditions nationales particulières
40
Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 93/42/CEE
41

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