NF EN ISO 10651-2

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Standards
NF EN ISO 10651-2

NF EN ISO 10651-2

July 2009

Standard Cancelled

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2 : home care ventilators for ventilator-dependent patients

ISO 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training. ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.The requirements of ISO 10651-2:2004 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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Collections

National standards and national normative documents

Publication date

July 2009

Number of pages

49 p.

Reference

NF EN ISO 10651-2

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

Classification index

S95-160-2

Print number

1 - 03/07/2009

International kinship

ISO 10651-2:2004

European kinship

EN ISO 10651-2:2009

Sumary

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2 : home care ventilators for ventilator-dependent patients

ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.

ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.

ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.

The requirements of ISO 10651-2:2004 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 10651-2

December 2004

Standard Cancelled

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2 : home care ventilators for ventilator-dependent patients

ISO 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training. ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988. ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators. ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients. The requirements of ISO 10651-2:2004 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 80601-2-72

November 2015

Standard Cancelled

Medical electrical equipment - Part 2-72 : particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

ISO 80601-2-72:2015 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: intended for use in the home healthcare environment; intended for use by a lay operator; intended for use with patients who are dependent on mechanical ventilation for their life support. ISO 80601-2-72:2015 is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601‑1 and ISO/IEC 80601 series of standards.

Table of contents

Avant-propos
vi
Introduction
vii
1 Domaine d'application
1
2 Références normatives
1
3 Termes et définitions
2
4 Exigences générales et exigences relatives aux essais
3
5 Classification
4
6 Identification, marquage et documentation
4
7 Puissance absorbée
9
8 Catégories fondamentales de sécurité
9
9 Moyens de protection amovibles
9
10 Conditions d'environnement
9
11 Non utilisé
10
12 Non utilisé
10
13 Généralités
10
14 Exigences relatives à la classification
10
15 Limitation de la tension et/ou de l'énergie
10
16 Enveloppes et capots de protection
10
17 Séparation
10
18 Mise à la terre de protection, mise à la terre fonctionnelle et égalisation des potentiels
10
19 Courants de fuite permanents et courants auxiliaires du patient
11
20 Rigidité diélectrique
11
21 Résistance mécanique
11
22 Parties en mouvement
11
23 Surfaces, angles et arétes
11
24 Stabilité en utilisation normale
11
25 Projection d'objets
11
26 Vibrations et bruit
11
27 Puissance pneumatique et hydraulique
11
28 Masses suspendues
12
29 Rayonnements X
12
30 Rayonnements alpha, bêta, gamma, neutroniques et d'autres particules
12
31 Rayonnements à micro-ondes
12
32 Rayonnements lumineux (y compris les rayonnements lasers)
12
33 Rayonnements infrarouges
12
34 Rayonnements ultraviolets
12
35 Énergie acoustique (y compris les ultrasons)
12
36 Compatibilité électromagnétique
12
37 Localisations et exigences fondamentales
12
38 Marquage et documents d'accompagnement
13
39 Exigences communes aux appareils de la catégorie AP et de la catégorie APG
13
40 Exigences et essais pour les appareils de catégorie AP, parties et composants de ceux-ci
13
41 Exigences et essais pour les appareils de la catégorie APG, parties d'appareils et composants de ceux-ci
13
42 Températures excessives
13
43 Prévention du feu
13
44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage, stérilisation, désinfection et compatibilité
14
45 Réservoirs et parties sous pression
15
46 Erreurs humaines
15
47 Charges électrostatiques
15
48 Biocompatibilité
15
49 Coupure de l'alimentation
15
50 Précision des caractéristiques de fonctionnement
16
51 Protection contre les caractéristiques de sortie présentant des risques
16
52 Fonctionnement anormal et conditions de défaut
19
53 Essais d'environnement
20
54 Généralités
20
55 Enveloppes et capots
20
56 Composants et ensembles
20
57 Parties reliées au réseau, composants et montage
23
58 Mise à la terre de protection - Bornes et raccordements
23
59 Construction et montage
23
101 Systèmes d'alarme
23
102 Appendices de la IEC 60601-1:1988
24
Annexe AA (informative) Justifications
25
Annexe BB (informative) Références aux principes essentiels
30
Bibliographie
32

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