SIST 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
Relations
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
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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SIST EN ISO 17510:2020
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
---------------------- Page: 8 ----------------------
SIST EN ISO 17510:2020
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 2015 – All rights reserved iii
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SIST EN ISO 17510:2020
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
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SIST EN ISO 17510:2020
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 equipment.
In this International Standard, the following print types are used:
— requirements and definitions: roman type;
— test specifications: italic type;
— informative material appearing outside of tables, such as notes, examples, and references: in smaller type.
Normative text of tables is also in a smaller type;
— Terms defined in Clause 3 in this International Standard or as noted: small capitals type.
In referring to the structure of this International Standard, the term
— “clause” means one of the numbered divisions within the table of contents, inclusive of all subdivisions
(e.g. Clause 5 includes 5.1, 5.2, etc.), and
— “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2, and 5.3.1 are all subclauses of
Clause 5).
References to clauses within this International Standard are preceded by the term “Clause” followed
by the clause number. References to subclauses within this particular International Standard are by
number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if
any combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in ISO/IEC Directives
Part 2, Annex H. For the purposes of this International Standard, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
International Standard;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this International Standard;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised
ISO publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the
content of this publication not be adopted for mandatory implementation nationally earlier than three
years from the date of publication for equipment newly designed and not earlier than five years from
the date of publication for equipment already in production.
© ISO 2015 – All rights reserved v
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SIST EN ISO 17510:2020
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SIST EN ISO 17510:2020
INTERNATIONAL STANDARD ISO 17510:2015(E)
Medical devices — Sleep apnoea breathing therapy —
Masks and application accessories
1 Scope
This International Standard applies to masks and their accessories used to connect 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).
Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the
typical elements of this International Standard together with the sleep apnoea breathing therapy
equipment of ISO 80601-2-70 that form a sleep apnoea breathing system.
This International Standard does not cover oral appliances.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 5356-2:2012, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
© ISO 2015 – All rights reserved 1
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SIST EN ISO 17510:2020
ISO 17510:2015(E)
ISO 80601-2-70:2015, Medical Electrical Equipment — Part 2-70: Particular requirements for basic safety
and essential performance of sleep apnoea breathing therapy equipment
IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135:2001, ISO 17664:2004,
ISO 23328-2:2002, ISO 80601-2-70:2015, IEC 60601-1:2005+A1:2012 and the following apply.
NOTE An alphabetical index of defined terms is found in Annex J.
3.1
anti-asphyxia valve
valve used on a mask, which covers the mouth and is opened to atmosphere when the sleep apnoea
breathing therapy equipment is not providing adequate pressure at the mask, and that is closed to
atmosphere when the sleep apnoea breathing therapy equipment is providing adequate pressure
at the mask
3.2
exhaust flow
flow from the mask or application accessory to atmosphere other than the leak due to improper seal
to the face
Note 1 to entry: The exhaust flow can pass through openings in the mask, the connecting element and the
mask, or through the anti-asphyxia valve.
Note 2 to entry: The exhaust flow discharges exhaled gases to atmosphere to reduce rebreathing of CO .
2
3.3
expected useful life
time period specified by the manufacturer during which the medical device or accessory is expected
to remain suitable for use under the conditions specified by the manufacturer
Note 1 to entry: Cleaning and other processing can be necessary during the expected useful life.
3.4
headgear
part that is used to fix the mask to the patient
3.5
mask
part which provides the interface between the patient and the patient-connection port
Note 1 to entry: According to their application, masks are divided into nasal masks, oral masks, or nasal-oral
masks.
3.6
multi-patient reuse
capable of being re-used multiple times on multiple patients
3.7
oral appliance
device intended to maintain the oral airway by mechanical means and which achieves its purpose
independently of sleep apnoea breathing therapy equipment
2 © ISO 2015 – All rights reserved
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SIST EN ISO 17510:2020
ISO 17510:2015(E)
3.8
single fault condition
condition of me equipment or accessory in which a single means for reducing a risk is defective or a
single abnormal condition is present
[SOURCE: IEC 60601-1:2005+A1:2012, 3.116, modified—added ‘or accessory’ and deleted note.]
3.9
single-patient reuse
capable of being used multiple times on the same patient
4 Information to be supplied by the manufacturer
4.1 General
Masks, headgear and other accessories shall be provided with an accompanying document. The
accompanying document shall be regarded as a part of masks, headgear and the accessories.
NOTE 1 The purpose of an accompanying document is to promote the safe use of a mask, headgear or other
accessory during the expected useful life.
NOTE 2 Annex H contains a guide to assist the reader in locating the marking and labelling requirements
contained in other clauses of ISO 17510.
4.2 Marking on the protective packaging
Packages of masks, headgear and other accessories shall be marked with:
a) name or trade name and address of
— the manufacturer, and
— where the manufacturer does not have an address within the locale, an authorized
representative within the locale,
to which the operator or responsible organization can refer;
b) the details strictly necessary to identify the device and the contents of the packaging especially for
the operator or responsible organization;
c) the identity and intended purpose of the mask and any application accessories;
d) any special storage and/or handling conditions;
e) any special operating instructions;
f) any special warnings and/or precautions to be taken;
g) if applicable, symbol from ISO 15223-1:2012, 5.1.4 indicating the latest date by which the mask and
any application accessories can be used safely (i.e. shelf life), expressed as the year, month and
day;
h) identification reference to the batch, type or serial number with symbol from ISO 15223-1:2012,
5.1.7 with an accompanying serialization or symbol from ISO 15223-1:2012, 5.1.5 with an
accompanying lot or batch identifier; and
i) for sterile items, with symbol ISO 15223-1:2012, 5.2.1, symbol ISO 15223-1:2012, 5.2.2, symbol
ISO 15223-1:2012, 5.2.3 or symbol ISO 15223-1:2012, 5.2.4, as appropriate.
Packaging for single use masks, headgear and other accessories shall be marked accordingly and
shall be consistent for a model or type reference.
© ISO 2015 – All rights reserved 3
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SIST EN ISO 17510:2020
ISO 17510:2015(E)
Check compliance by inspection without opening the packaging.
4.3 Accompanying document
The accompanying document of the mask, headgear, or other accessory shall contain the following
information:
a) name or trade name and address of
— the manufacturer; and
— where the manufacturer does not have an address within the locale, an authorized
representative within the locale,
to which the operator or responsible organization can refer;
b) the identity and the intended purpose of the mask and any application accessories;
c) the details of any treatment or handling needed before the mask or accessory can be used;
d) if provided sterile,
— an indication of the method of sterilization using symbol ISO 15223-1:2012, 5.2.1, symbol
ISO 15223-1:2012, 5.2.2, symbol ISO 15223-1:2012, 5.2.3 or symbol ISO 15223-1:2012, 5.2.4, as
appropriate;
— instructions necessary in the event of damage to the sterile packaging and details of appropriate
methods of resterilization;
e) if the packaging contains more than one component information necessary for correct assembly of
the components;
f) information necessary to verify whether the mask or accessory is properly installed and can
operate correctly and safely;
g) if the mask or accessory includes an exhaust port, a warning statement to the effect that:
“WARNING: Occlusion of the exhaust needs to be prevented to avoid having an adverse effect on the
safety and quality of the therapy”;
h) a statement to the effect that combination with other medical devices not intended to be combined
with the mask can decrease the safety or alter the performance of the mask (e.g. in combination
with a humidifier for medical use, nebulizer, heat and moisture exchanger (HME), filters, bi-level
positive airway pressure equipment, self-adjusting equipment, or additional oxygen supply or any
exhaust port);
i) if applicable, information about the means provided to minimize rebreathing (see 5.3);
j) the rated pressure range of the mask including any connecting element;
k) information to enable the responsible organization (prescriber) to inform the patient of
— any potential contraindications and any precautions that might need to be taken,
— any precautions to be taken in the event of changes in performance, and
— any precautions to be taken regarding to risks associated with disposal;
l) if specified for reuse:
— the information specified in ISO 17664:2004, 3.9, if sterilizable;
— a warning statement to the effect that: “WARNING: frequency of cleaning, methods of cleaning
or the use of cleaning agents, other than those specified in the accompanying documents, or
4 © ISO 2015 – All rights reserved
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SIST EN ISO 17510:2020
ISO 17510:2015(E)
exceeding the number of processing cycles can have an adverse effect on the [place name of
component here] and consequently the safety or the quality of the therapy”;
m) information about the nature and frequency of regular and preventative maintenance of the mask
or accessory, including information about the replacement of consumable components during the
expected useful life of the mask or accessory;
n) information for the operator to identify parameters or criteria that could indicate a safety or
efficacy change in the mask or accessory (e.g. visual inspection criteria); as well as the course of
action to follow as a result of this identification (e.g. disposal or component replacement procedure);
o) the expected useful life of masks and any accessories;
p) * the resistance, derived from pressure drop, between the mask and the patient-connection port
at flowrates of 50 l/min and 100 l/min, as determined in Annex C;
q) * for masks that cover the nose and the mouth, the inspiratory, and expiratory resistance of the
mask in combination with the anti-asphyxia valve open to atmosphere, as determined in Annex E;
r) * the pressure-flow curve of the exhaust flow throughout the working pressure range as
determined in Annex B;
s) * the date of issue or revision level of the accompanying document.
Check compliance by inspection of the accompanying document.
5 Construction requirements
5.1 Mask connectors
Mask connectors, if conical, shall be 15 mm or 22 mm size male connectors conforming to
ISO 5356-1:2015 or ISO 5356-2:2012.
Non-conical mask connectors shall not engage with conical connectors conforming to ISO 5356-1:2015
or ISO 5356-2:2012, unless they comply with the engagement, disengagement, and leakage requirements
of ISO 5356-1:2015 or ISO 5356-2:2012.
Ch
...
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
---------------------- Page: 4 ----------------------
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 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
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oSIST prEN ISO 17510:2019
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.
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oSIST prEN ISO 17510:2019
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 equipment.
In this International Standard, the following print types are used:
— requirements and definitions: roman type;
— test specifications: italic type;
— informative material appearing outside of tables, such as notes, examples, and references: in smaller type.
Normative text of tables is also in a smaller type;
— Terms defined in Clause 3 in this International Standard or as noted: small capitals type.
In referring to the structure of this International Standard, the term
— “clause” means one of the numbered divisions within the table of contents, inclusive of all subdivisions
(e.g. Clause 5 includes 5.1, 5.2, etc.), and
— “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2, and 5.3.1 are all subclauses of
Clause 5).
References to clauses within this International Standard are preceded by the term “Clause” followed
by the clause number. References to subclauses within this particular International Standard are by
number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if
any combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in ISO/IEC Directives
Part 2, Annex H. For the purposes of this International Standard, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
International Standard;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this International Standard;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised
ISO publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the
content of this publication not be adopted for mandatory implementation nationally earlier than three
years from the date of publication for equipment newly designed and not earlier than five years from
the date of publication for equipment already in production.
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oSIST prEN ISO 17510:2019
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oSIST prEN ISO 17510:2019
INTERNATIONAL STANDARD ISO 17510:2015(E)
Medical devices — Sleep apnoea breathing therapy —
Masks and application accessories
1 Scope
This International Standard applies to masks and their accessories used to connect 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).
Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the
typical elements of this International Standard together with the sleep apnoea breathing therapy
equipment of ISO 80601-2-70 that form a sleep apnoea breathing system.
This International Standard does not cover oral appliances.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 5356-2:2012, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
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oSIST prEN ISO 17510:2019
ISO 17510:2015(E)
ISO 80601-2-70:2015, Medical Electrical Equipment — Part 2-70: Particular requirements for basic safety
and essential performance of sleep apnoea breathing therapy equipment
IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135:2001, ISO 17664:2004,
ISO 23328-2:2002, ISO 80601-2-70:2015, IEC 60601-1:2005+A1:2012 and the following apply.
NOTE An alphabetical index of defined terms is found in Annex J.
3.1
anti-asphyxia valve
valve used on a mask, which covers the mouth and is opened to atmosphere when the sleep apnoea
breathing therapy equipment is not providing adequate pressure at the mask, and that is closed to
atmosphere when the sleep apnoea breathing therapy equipment is providing adequate pressure
at the mask
3.2
exhaust flow
flow from the mask or application accessory to atmosphere other than the leak due to improper seal
to the face
Note 1 to entry: The exhaust flow can pass through openings in the mask, the connecting element and the
mask, or through the anti-asphyxia valve.
Note 2 to entry: The exhaust flow discharges exhaled gases to atmosphere to reduce rebreathing of CO .
2
3.3
expected useful life
time period specified by the manufacturer during which the medical device or accessory is expected
to remain suitable for use under the conditions specified by the manufacturer
Note 1 to entry: Cleaning and other processing can be necessary during the expected useful life.
3.4
headgear
part that is used to fix the mask to the patient
3.5
mask
part which provides the interface between the patient and the patient-connection port
Note 1 to entry: According to their application, masks are divided into nasal masks, oral masks, or nasal-oral
masks.
3.6
multi-patient reuse
capable of being re-used multiple times on multiple patients
3.7
oral appliance
device intended to maintain the oral airway by mechanical means and which achieves its purpose
independently of sleep apnoea breathing therapy equipment
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oSIST prEN ISO 17510:2019
ISO 17510:2015(E)
3.8
single fault condition
condition of me equipment or accessory in which a single means for reducing a risk is defective or a
single abnormal condition is present
[SOURCE: IEC 60601-1:2005+A1:2012, 3.116, modified—added ‘or accessory’ and deleted note.]
3.9
single-patient reuse
capable of being used multiple times on the same patient
4 Information to be supplied by the manufacturer
4.1 General
Masks, headgear and other accessories shall be provided with an accompanying document. The
accompanying document shall be regarded as a part of masks, headgear and the accessories.
NOTE 1 The purpose of an accompanying document is to promote the safe use of a mask, headgear or other
accessory during the expected useful life.
NOTE 2 Annex H contains a guide to assist the reader in locating the marking and labelling requirements
contained in other clauses of ISO 17510.
4.2 Marking on the protective packaging
Packages of masks, headgear and other accessories shall be marked with:
a) name or trade name and address of
— the manufacturer, and
— where the manufacturer does not have an address within the locale, an authorized
representative within the locale,
to which the operator or responsible organization can refer;
b) the details strictly necessary to identify the device and the contents of the packaging especially for
the operator or responsible organization;
c) the identity and intended purpose of the mask and any application accessories;
d) any special storage and/or handling conditions;
e) any special operating instructions;
f) any special warnings and/or precautions to be taken;
g) if applicable, symbol from ISO 15223-1:2012, 5.1.4 indicating the latest date by which the mask and
any application accessories can be used safely (i.e. shelf life), expressed as the year, month and
day;
h) identification reference to the batch, type or serial number with symbol from ISO 15223-1:2012,
5.1.7 with an accompanying serialization or symbol from ISO 15223-1:2012, 5.1.5 with an
accompanying lot or batch identifier; and
i) for sterile items, with symbol ISO 15223-1:2012, 5.2.1, symbol ISO 15223-1:2012, 5.2.2, symbol
ISO 15223-1:2012, 5.2.3 or symbol ISO 15223-1:2012, 5.2.4, as appropriate.
Packaging for single use masks, headgear and other accessories shall be marked accordingly and
shall be consistent for a model or type reference.
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oSIST prEN ISO 17510:2019
ISO 17510:2015(E)
Check compliance by inspection without opening the packaging.
4.3 Accompanying document
The accompanying document of the mask, headgear, or other accessory shall contain the following
information:
a) name or trade name and address of
— the manufacturer; and
— where the manufacturer does not have an address within the locale, an authorized
representative within the locale,
to which the operator or responsible organization can refer;
b) the identity and the intended purpose of the mask and any application accessories;
c) the details of any treatment or handling needed before the mask or accessory can be used;
d) if provided sterile,
— an indication of the method of sterilization using symbol ISO 15223-1:2012, 5.2.1, symbol
ISO 15223-1:2012, 5.2.2, symbol ISO 15223-1:2012, 5.2.3 or symbol ISO 15223-1:2012, 5.2.4, as
appropriate;
— instructions necessary in the event of damage to the sterile packaging and details of appropriate
methods of resterilization;
e) if the packaging contains more than one component information necessary for correct assembly of
the components;
f) information necessary to verify whether the mask or accessory is properly installed and can
operate correctly and safely;
g) if the mask or accessory includes an exhaust port, a warning statement to the effect that:
“WARNING: Occlusion of the exhaust needs to be prevented to avoid having an adverse effect on the
safety and quality of the therapy”;
h) a statement to the effect that combination with other medical devices not intended to be combined
with the mask can decrease the safety or alter the performance of the mask (e.g. in combination
with a humidifier for medical use, nebulizer, heat and moisture exchanger (HME), filters, bi-level
positive airway pressure equipment, self-adjusting equipment, or additional oxygen supply or any
exhaust port);
i) if applicable, information about the means provided to minimize rebreathing (see 5.3);
j) the rated pressure range of the mask including any connecting element;
k) information to enable the responsible organization (prescriber) to inform the patient of
— any potential contraindications and any precautions that might need to be taken,
— any precautions to be taken in the event of changes in performance, and
— any precautions to be taken regarding to risks associated with disposal;
l) if specified for reuse:
— the information specified in ISO 17664:2004, 3.9, if sterilizable;
— a warning statement to the effect that: “WARNING: frequency of cleaning, methods of cleaning
or the use of cleaning agents, other than those specified in the accompanying documents, or
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oSIST prEN ISO 17510:2019
ISO 17510:2015(E)
exceeding the number of processing cycles can have an adverse effect on the [place name of
component here] and consequently the safety or the quality of the therapy”;
m) information about the nature and frequency of regular and preventative maintenance of the mask
or accessory, including information about the replacement of consumable components during the
expected useful life of the mask or accessory;
n) information for the operator to identify parameters or criteria that could indicate a safety or
efficacy change in the mask or accessory (e.g. visual inspection criteria); as well as the course of
action to follow as a result of this identification (e.g. disposal or component replacement procedure);
o) the expected useful life of masks and any accessories;
p) * the resistance, derived from pressure drop, between the mask and the patient-connection port
at flowrates of 50 l/min and 100 l/min, as determined in Annex C;
q) * for masks that cover the nose and the mouth, the inspiratory, and expiratory resistance of the
mask in combination with the anti-asphyxia valve open to atmosphere, as determined in Annex E;
r) * the pressure-flow curve of the exhaust flow throughout the working pressure range as
determined in Annex B;
s) * the date of issue or revision level of the accompanying document.
Check compliance by inspection of the accompanying document.
5 Construction requirements
5.1 Mask connectors
Mask connectors, if conical, shall be 15 mm or 22 mm size male connectors conforming to
ISO 5356-1:2015 or ISO 5356-2:2012.
Non-conical mask connectors shall not engage with conical connectors conforming to ISO 5356-1:2015
or ISO 5356-2:2012, unless they comply with the engagement, disengagement, and leakage requirements
of ISO 5356-1:2015 or ISO 5356-2:2012.
Check compliance by inspection and functional testing.
5.2 Biocompatibility
Parts or materials that are intended to be in contact with the patient or patient gas pathway during
normal use shall be evaluated according to ISO 10993-1:2009.
NOTE 1 The gas pathways should be evaluated to ISO 18562-1:—, upon its publication.
Parts or materials that are intended to be inserted into the nares or the mouth shall be evaluated as
mucosal membrane contact.
For parts or materials not intended to be inserted into the nares or mouth (e.g. mask elbows, tubing,
cushions, and faceplates), the gas pathway materials shall be evaluated as skin contact.
For mask materials, including headgear, intended to contact the patient’s head, the materials shall be
evaluated as skin contact.
All materials shall be considered as for permanent duration contact as categorized in ISO 10993-1:2009.
NOTE 2 Permanent duration contact is required because sleep apnoea breathing therapy equipment and
accessories have cumulative usage that is greater than 30 d.
Natural rubber latex shall not be used in the mask or accessories.
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oSIST prEN ISO 17510:2019
ISO 17510:2015(E)
The manufacturer of a mask or accessories shall address in the risk management process the
risks associated with the leaching or leaking of substances into the gas pathway. Special attention shall
be given to substances which are carcinogenic, mutagenic, or toxic to reproduction.
A mask or accessory that contains phthalates which are classified as carcinogenic, mutagenic or toxic
to reproduction shall be marked on the mask or accessory itself or on the packaging that it contains
phthalates. If the intended use of a mask or accessory includes treatment of children or treatment of
pregnant or nursing women, a specific justification for the use of these phthalates shall be included in
the risk management file. The accompanying document of a mask or accessory that contains such
phthalates shall contain information on residual risks for these patient groups and, if applicable, on
appropriate precautionary measures.
Check compliance by the application of ISO 10993-1:2009, inspection of the accompanying document
and inspection of the risk management file for identification of the presence of substances which are
carcinogenic, mutagenic or toxic to reproduction and justification for their use.
5.3 * Protection against rebreathing
5.3.1 Normal condition protection
Means shall be provided to minimize the risk of rebreathing during normal condition. The means
may be integral to the mask or other application accessory or located in the sleep apnoea breathing
therapy equipment.
Under normal condition, the relative CO increase shall not exceed 20 % when tested at
2
— the minimum rated pressure,
— a pressure of 5 hPa (5 cmH O), and
2
— a pressure of 10 hPa (10 cmH O).
2
Check compliance by the tests described in Annex F.
5.3.2 Single fault condition protection
Masks that cover the mouth shall be designed to minimize rebreathing during single fault
condition.
Under single fault condition, the relative CO increase shall not exceed 60 % when tested
2
— with blockage of the breathing tube, and
— at the equipment-end of the breathing tube open to atmosphere.
NOTE Patients can open their mouth and breathe normally under single fault condition for a mask that
only covers the nose.
Check compliance by the tests described in Annex F.
5.4 Cleaning, disinfection, and sterilization
The mask and any accessories, whether for single-patient reuse or multi-patient reuse, shall
be designed so that contaminant-trapping features are minimized and can be easily cleaned by the
operator.
The mask and any accessories and their parts intended for multi-patient reuse shall be so
constructed that they can be cleaned and disinfected or cleaned and sterilized.
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