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CEN

EN ISO 17510:2020

(Main)

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

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
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Feb-2020
Due Date
17-Sep-2021
Completion Date
19-Feb-2020
Ref Project
SIST EN ISO 17510:2020 - Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)

Relations

Replaces
EN ISO 17510-2:2009 - Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
Effective Date
26-Feb-2020

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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.

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
ISO 17510:2015(E)
© 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

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 condition protection . 6
5.4 Cleaning, disinfection, and sterilization . 6
5.5 Breathing during single fault condition . 7
5.6 Breathing system filter . 7
6 Vibration and noise . 7
Annex A (informative) Particular guidance and rationale . 8
Annex B (normative) Exhaust flow test procedure .12
Annex C (normative) Resistance to flow (pressure drop) .14
Annex D (normative) Anti-asphyxia valve pressure testing .16
Annex E (normative) Determination of the inspiratory and expiratory resistance under
single fault condition .18
Annex F (normative) Carbon Dioxide rebreathing .20
Annex G (normative) Vibration and noise .23
Annex H (informative) Guide to information to be supplied by the manufacturer .25
Annex I (informative) Reference to the essential principles .26
Annex J (informative) Terminology — alphabetized index of defined terms .28
Bibliography .30
ISO 17510:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This first edition cancels and replaces the second edition of ISO 17510-2:2007 which has been technically
revised with the following changes:
— removing the single fault condition testing for rebreathing for nasal-only masks as patients
can breathe through their mouth in that circumstance;
— referencing ISO 80601-2-70 for sleep apnoea therapy equipment.
NOTE ISO 17510-1 was replaced by ISO 80601-2-70.
iv © ISO 2015 – All rights reserved

ISO 17510:2015(E)
Introduction
Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during
sleep. The awareness of the risks associated with sleep apnoea has grown significantly in recent
years. As a result, the use of sleep apnoea breathing therapy equipment has become common. This
International Standard covers basic safety and essential performance requirements for masks and
other application accessories needed to protect patients during use of this
...

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EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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