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National standards and national normative documents

Publication date

July 2009

Number of pages

41 p.

Reference

NF EN ISO 17510-2

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

11.040.60 Therapy equipment

Classification index

S95-182-2

Print number

1 - 18/06/2009

International kinship

ISO 17510-2:2007

European kinship

EN ISO 17510-2:2009

Sumary

Sleep apnoea breathing therapy - Part 2 : masks and application accessories

ISO 17510-2:2007 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear.

ISO 17510-2:2007 does not cover oral appliances.

Replaced standards (1)

NF EN ISO 17510-2

November 2007

Standard Cancelled

Sleep apnoea breathing therapy - Part 2 : masks and application accessories

ISO 17510-2:2007 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear. ISO 17510-2:2007 does not cover oral appliances.

Standard replaced by (1)

NF EN ISO 17510

February 2020

Standard Current

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

ISO 17510:2015 applies to masks and their accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

Table of contents

Avant-propos
iv
Introduction
v
1 Domaine d'application
1
2 Références normatives
1
3 Termes et définitions
2
4 Informations devant être fournies par le fabricant
3
5 Exigences relatives à la construction
4
5.1 Raccords de masque
4
5.2 Biocompatibilité
5
5.3 Protection contre la réinhalation
5
5.4 Nettoyage, désinfection et stérilisation
5
5.5 Respiration dans des conditions de premier défaut
6
5.6 Filtre du système respiratoire
6
6 Vibrations et bruit
6
Annexe A (informative) Exposé des motifs
7
Annexe B (normative) Mode opératoire d'essai du flux d'évacuation
11
Annexe C (normative) Résistance au débit (chute de pression)
13
Annexe D (normative) Essais de pression de la valve antiasphyxie
15
Annexe E (normative) Respiration dans des conditions de premier défaut - Détermination de la résistance inspiratoire et expiratoire
17
Annexe F (normative) Réinhalation de C02
19
Annexe G (normative) Vibrations et bruit
22
Annexe H (informative) Guide relatif aux informations devant être fournies par le fabricant
23
Annexe I (informative) Référence aux principes essentiels
24
Annexe J (informative) Aspects environnementaux
26
Annexe K (informative) Terminologie - Index alphabétique des termes définis
27
Bibliographie
29

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