NF EN ISO 17510-2
Sleep apnoea breathing therapy - Part 2 : masks and application accessories
ISO 17510-2:2002 specifies requirements for masks and accessories which are required to connect the patient connection port to a sleep apnoea breathing therapy device and the mask to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, gas exhaust ports, connecting elements and headgear.ISO 17510-2:2002 does not cover oral appliances.NOTE 1 Sleep apnoea breathing therapy devices are covered by ISO 17510-1 (see A.1 for typical elements of the two parts of ISO 17510).NOTE 2 Annex A contains rationale statements for ISO 17510-2:2002.
ISO 17510-2:2002 specifies requirements for masks and accessories which are required to connect the patient connection port to a sleep apnoea breathing therapy device and the mask to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, gas exhaust ports, connecting elements and headgear.
ISO 17510-2:2002 does not cover oral appliances.
NOTE 1 Sleep apnoea breathing therapy devices are covered by ISO 17510-1 (see A.1 for typical elements of the two parts of ISO 17510).
NOTE 2 Annex A contains rationale statements for ISO 17510-2:2002.
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.
- Avant-propos3
-
1Domaine d'application 4
-
2Références normatives 4
-
3Termes et définitions 4
-
4Informations devant être fournies par le fabricant 5
-
5Exigences relatives à la construction 6
-
5.1Raccords du masque facial 6
-
5.2Compatibilité 6
-
5.3Ré-inhalation 6
-
6Méthodes d'essai 6
-
6.1Essai de détermination du niveau de pression acoustique de l'orifice d'évacuation de gaz 6
-
6.2Essai pour déterminer la résistance au débit 7
- Annexe A (informative) Exposé des motifs9
- Annexe ZA (informative) Articles de la présente Norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE11
- With a single click, add a new language, the Requirements or Redline+ service and add one or more additional users.
- Whether you are in the process of acquiring a standard or it is already available in your personal space, the UPSELL service is available at every stage to help you understand it and implement it within your organization.
COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.
Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!
Request your free, no-obligation live demo
I discover COBAZ