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EN ISO 17510-2:2007

(Main)

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

This part of ISO 17510 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. Sleep apnoea breathing therapy equipment is covered by ISO 17510-1. See Figure A.1 for typical elements of the two parts of ISO 17510. This part of ISO 17510 does not cover oral appliances.

Schlafapnoe-Atemtherapie - Teil 2: Masken und Anwendungszubehör (ISO 17510-2:2007)

Dieser Teil von ISO 17510 gilt für Masken, ihre Verbindungselemente und für Zubehörteile, die verwendet werden, um ein Schlafapnoe Atemtherapiegerät an den Patienten anzuschließen. Er legt Anforderungen an Masken und Zubehörteile, einschließlich aller Verbindungs¬elemente, fest, die erforderlich sind, um die Patientenanschlussöffnung des Schlafapnoe Atemtherapiegeräts mit einem Patienten zu verbinden, und die bei Anwendung der Schlafapnoe Atemtherapie eingesetzt werden, z. B. Nasenmasken, Abgasöffnungen und Kopfgeschirr.
Schlafapnoe Atemtherapiegeräte werden in ISO 17510 1 behandelt. Siehe auch Bild A.1, in dem die typischen Bestandteile der beiden Teile von ISO 17510 dargestellt sind.
Dieser Teil von ISO 17510 behandelt keine oralen Vorrichtungen.

Thérapie respiratoire de l'apnée du sommeil - Partie 2: Masques et accessoires d'application (ISO 17510-2:2007)

Zdravljenje dihanja pri prenehanju dihanja v spanju - 2. del: Maske in oprema za nameščanje (ISO 17510-2:2007)

General Information

Status
Withdrawn
Publication Date
30-Sep-2007
Withdrawal Date
10-Mar-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
11-Mar-2009
Completion Date
11-Mar-2009
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 17510-2:2008 - Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

Relations

Replaces
EN ISO 17510-2:2003 - Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2003)
Effective Date
22-Dec-2008
Replaced By
EN ISO 17510-2:2009 - Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
Effective Date
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 17510-2:2008
01-april-2008
1DGRPHãþD
SIST EN ISO 17510-2:2003
=GUDYOMHQMHGLKDQMDSULSUHQHKDQMXGLKDQMDYVSDQMXGHO0DVNHLQRSUHPD]D
QDPHãþDQMH ,62
Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510
-2:2007)
Schlafapnoe-Atemtherapie - Teil 2: Masken und Anwendungszubehör (ISO 17510-
2:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 2: Masques et accessoires
d'application (ISO 17510-2:2007)
Ta slovenski standard je istoveten z: EN ISO 17510-2:2007
ICS:
11.040.10
SIST EN ISO 17510-2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN ISO 17510-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2007
ICS 11.040.10 Supersedes EN ISO 17510-2:2003
English Version
Sleep apnoea breathing therapy - Part 2: Masks and application
accessories (ISO 17510-2:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 2: Schlafapnoe-Atemtherapie - Teil 2: Masken und
Masques et accessoires d'application (ISO 17510-2:2007) Anwendungszubehör (ISO 17510-2:2007)
This European Standard was approved by CEN on 30 September 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510-2:2007: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN ISO 17510-2:2007 (E)
Contents Page
Foreword.3
Annex ZA (informative)  Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC .4

2

---------------------- Page: 3 ----------------------

EN ISO 17510-2:2007 (E)
Foreword
This document (EN ISO 17510-2:2007) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment" in collaboration with 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 April 2008, and conflicting national standards shall be withdrawn at the
latest by April 2008.
This document supersedes EN ISO 17510-2:2003.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 17510-2:2007 has been approved by CEN as a EN ISO 17510-2:2007 without any
modification.
3

---------------------- Page: 4 ----------------------

EN ISO 17510-2:2007 (E)
Annex ZA
(informative)

Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Ess
...

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