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Publication date

July 2009

Number of pages

51 p.

Reference

NF EN ISO 17510-1

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

11.040.60 Therapy equipment

Classification index

S95-182-1

Print number

1 - 18/06/2009

International kinship

ISO 17510-1:2007

European kinship

EN ISO 17510-1:2009

Sumary

Sleep apnoea breathing therapy - Part 1 : sleep apnoea breathing therapy equipment

ISO 17510-1:2007 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.

ISO 17510-1:2007 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates.

Jet and very high frequency ventilation and oscillation are not considered in ISO 17510-1:2007.

Replaced standards (1)

NF EN ISO 17510-1

November 2007

Standard Cancelled

Sleep apnoea breathing therapy - Part 1 : sleep apnoea breathing therapy equipment

ISO 17510-1:2007 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions. ISO 17510-1:2007 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates. Jet and very high frequency ventilation and oscillation are not considered in ISO 17510-1:2007.

Standard replaced by (1)

NF EN ISO 80601-2-70

November 2020

Standard Current

Medical electrical equipment - Part 2-70 : particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. 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. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]. This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8]. This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9]. This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12]. This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601‑2‑80[11].

Table of contents

Avant-propos
v
Introduction
vi
1 Domaine d'application
1
2 Références normatives
2
3 Termes et définitions
3
4 Exigences
4
5 Classification et désignation
4
6 Marquage, étiquetage et emballage
4
7 Puissance absorbée
8
8 Catégories fondamentales de sécurité
8
9 Moyens de protection amovibles
8
10 Conditions d'environnement
8
11 Non utilisé
9
12 Non utilisé
9
13 Généralités
9
14 Exigences relatives à la classification
9
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 courant auxiliaire patient
10
20 Tension de tenue
10
21 Résistance mécanique
10
22 Parties en mouvement
10
23 Surfaces, angles et arêtes
10
24 Stabilité en utilisation normale
11
25 Projection d'objets
11
26 Vibrations et bruit
11
27 Puissance pneumatique et puissance hydraulique
12
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
13
37 Localisations et exigences fondamentales
13
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 la catégorie AP, parties et composants de ceux-ci
13
41 Exigences et essais pour les appareils de la catégorie APG, parties et composants de ceux-ci
13
42 Températures excessives
13
43 Prévention du feu
14
44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage, stérilisation et désinfection
14
45 Réservoirs et parties sous pression
15
46 Erreurs humaines
15
47 Charges électrostatiques
15
48 Biocompatibilité
15
49 Coupure de l'alimentation électrique
16
50 Précision des caractéristiques de fonctionnement
16
51 Protection contre les caractéristiques de sortie présentant des risques
16
52 Fonctionnement anormal et conditions de défauts
17
53 Essais d'environnement
17
54 Généralités
17
55 Enveloppes et capots
18
56 Composants et ensembles
18
57 Parties reliées au réseau, composants et montage
20
58 Mise à la terre de protection - Bornes et raccordements
20
59 Construction et montage
20
Annexe AA (informative) Exposé des motifs
21
Annexe BB (normative) Méthodes d'essai portant sur l'exactitude de la pression en utilisation normale
27
Annexe CC (normative) Méthode d'essai du débit maximal
30
Annexe DD (informative) Aspects environnementaux
31
Annexe EE (informative) Référence aux principes essentiels
33
Annexe FF (informative) Terminologie - Index alphabétique des termes définis
35
Bibliographie
37

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