NF EN ISO 17510

NF EN ISO 17510

February 2020
Standard Current
  • Free consultation authorized exceptionally by ISO and IEC in the context of the Covid-19 crisis

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).

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Main informations

Collections

National standards and national normative documents

Publication date

February 2020

Number of pages

40 p.

Reference

NF EN ISO 17510

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment
11.040.60   Therapy equipment

Classification index

S95-182

Print number

1

International kinship

ISO 17510:2015

European kinship

EN ISO 17510:2020
Sumary
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).

Replaced standards (2)
NF EN ISO 17510-2
July 2009
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.

NF ISO 17510
October 2015
Standard Cancelled
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
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Informations devant être fournies par le fabricant
  • 5 Exigences relatives à la construction
  • 6 Vibrations et bruit
  • Annexe A Préconisations particulières t exposé des motifs
  • Annexe B Mode opératoire de l'essai de débit d'évacuation
  • Annexe C Résistance au débit (chute de pression)
  • Annexe D Essais de mesure de la pression de la valve anti-asphyxie
  • Annexe E Détermination de la résistance inspiratoire et expiratoire en condition de premier défaut
  • Annexe F reinhalation de dioxyde de carbone
  • Annexe G Vibrations et bruit
  • Annexe H Guide relatif aux informations devant être fournies par le fabricant
  • Annexe I Référence aux principes essentiels
  • Annexe J Terminologie - Index alphabétique des termes définis
  • Bibliographie
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