Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)

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).

Medizinische Geräte - Schlafapnoe-Atemtherapie - Masken und Anwendungszubehör (ISO 17510:2015)

Diese Internationale Norm gilt für MASKEN und ihr ZUBEHÖR, die/das verwendet werden/wird, um SCHLAFAPNOE-ATEMTHERAPIEGERÄTE mit dem PATIENTEN zu verbinden. Sie legt Anforderungen an MASKEN und ZUBEHÖR, einschließlich aller Verbindungselemente, fest, die/das erforderlich ist/sind, um die PATIENTENANSCHLUSSÖFFNUNG des SCHLAFAPNOE ATEMTHERAPIEGERÄTS mit einem PATIENTEN für die Anwendung der Schlafapnoe Atemtherapie zu verbinden (z. B. NasenMASKEN, ABGASÖFFNUNGEN und KOPFGESCHIRR).
SCHLAFAPNOE ATEMTHERAPIEGERÄTE werden in ISO 80601 2 70 behandelt. Bild A.1 zeigt die typischen Elemente dieser Internationalen Norm zusammen mit dem SCHLAFAPNOE ATEMTHERAPIEGERÄT nach ISO 80601 2 70, die ein Schlafapnoe-Atemsystem bilden.
Diese Internationale Norm deckt keine ORALEN VORRICHTUNGEN ab.

Dispositifs médicaux - Thérapie respiratoire de l'apnée du sommeil - Masques et accessoires d'application (ISO 17510:2015)

L'ISO 17510:2015 s'applique aux masques et à leurs accessoires utilisés pour raccorder un matériel de traitement respiratoire de l'apnee du sommeil au patient. Elle spécifie les exigences relatives aux masques et aux accessoires, y compris tout élément de raccordement, nécessaires pour raccorder l'orifice de raccordement cote patient du materiel de traitement respiratoire de l'apnee du sommeil à un patient pour le traitement respiratoire de l'apnée du sommeil (par exemple, le masque nasal, les orifices d'évacuation et le harnais).

Medicinski pripomočki - Zdravljenje dihanja pri spalni apneji - Maske in oprema za nameščanje (ISO 17510:2015)

General Information

Status
Published
Publication Date
18-Feb-2020
Withdrawal Date
30-Aug-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Feb-2020
Due Date
17-Sep-2021
Completion Date
19-Feb-2020

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 17510:2020
01-april-2020
Nadomešča:
SIST EN ISO 17510-2:2009
Medicinski pripomočki - Zdravljenje dihanja pri spalni apneji - Maske in oprema za
nameščanje (ISO 17510:2015)
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
(ISO 17510:2015)
Medizinische Geräte - Schlafapnoe-Atemtherapie - Masken und Anwendungszubehör
(ISO 17510:2015)
Dispositifs médicaux - Thérapie respiratoire de l'apnée du sommeil - Masques et
accessoires d'application (ISO 17510:2015)
Ta slovenski standard je istoveten z: EN ISO 17510:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 17510:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 17510:2020

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SIST EN ISO 17510:2020


EN ISO 17510
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Medical devices - Sleep apnoea breathing therapy - Masks
and application accessories (ISO 17510:2015)
Dispositifs médicaux - Thérapie respiratoire de l'apnée Medizinische Geräte - Schlafapnoe-Atemtherapie -
du sommeil - Masques et accessoires d'application (ISO Masken und Anwendungszubehör (ISO 17510:2015)
17510:2015)
This European Standard was approved by CEN on 11 November 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510:2020 E
worldwide for CEN national Members.

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SIST EN ISO 17510:2020
EN ISO 17510:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 17510:2020
EN ISO 17510:2020 (E)
European foreword
The text of ISO 17510:2015 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 17510:2020 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2020, and conflicting national standards shall
be withdrawn at the latest by August 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 17510-2:2009.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 17510:2015 has been approved by CEN as EN ISO 17510:2020 without any modification.

3

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SIST EN ISO 17510:2020

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SIST EN ISO 17510:2020
IN
...

SLOVENSKI STANDARD
oSIST prEN ISO 17510:2019
01-oktober-2019
Medicinski pripomočki - Zdravljenje dihanja pri spalni apneji - Maske in oprema za
nameščanje (ISO 17510:2015)
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
(ISO 17510:2015)
Medizinische Geräte - Schlafapnoe-Atemtherapie - Masken und Anwendungszubehör
(ISO 17510:2015)
Dispositifs médicaux - Thérapie respiratoire de l'apnée du sommeil - Masques et
accessoires d'application (ISO 17510:2015)
Ta slovenski standard je istoveten z: prEN ISO 17510
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 17510:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 17510:2019

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oSIST prEN ISO 17510:2019
INTERNATIONAL ISO
STANDARD 17510
First edition
2015-08-01
Medical devices — Sleep apnoea
breathing therapy — Masks and
application accessories
Dispositifs médicaux — Thérapie respiratoire de l’apnée du sommeil
— Masques et accessoires d’application
Reference number
ISO 17510:2015(E)
©
ISO 2015

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oSIST prEN ISO 17510:2019
ISO 17510:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

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oSIST prEN ISO 17510:2019
ISO 17510:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Information to be supplied by the manufacturer . 3
4.1 General . 3
4.2 Marking on the protective packaging . 3
4.3 A ccompanying document . 4
5 Construction requirements . 5
5.1 Ma sk connectors . 5
5.2 Biocompatibility . 5
5.3 Protection against rebreathing . 6
5.3.1 Normal condition protection . 6
5.3.2 Single fault condit
...

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