SIST EN ISO 17510-2:2008
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)
Dieses Dokument legt Anforderungen an Masken und Zubehörteile, einschließlich aller Atemschläuche, 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, Atemschläuche und Kopfgeschirr.
ANMERKUNG Schlafapnoe-Atemtherapiegeräte werden in EN ISO 17510-1 behandelt. Siehe auch Bild A.1, in dem die typischen Bestandteile der beiden Normteile von EN ISO 17510 dargestellt sind.
Dieser Teil von EN 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 17510-2:2008
01-april-2008
1DGRPHãþD
SIST EN ISO 17510-2:2003
=GUDYOMHQMHGLKDQMDSULSUHQHKDQMXGLKDQMDYVSDQMXGHO 0DVNHLQRSUHPD]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.
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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.
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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
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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
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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 Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993, on the approximation of the laws of the
Member States concerning medical devices (Medical Device Directive).
Once this document is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
document given in Table ZA.1 confers, within the limits of the scope of this document, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this document and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential requirements (ERs) of EU Qualifying remarks/Notes
this document Directive 93/42/EEC
All 1, 2, 3
4 13.1, 13.6 a)
4.1 a) 13.3 a)
4.1 b) 13.3 b)
4.1 c) 9.1, 13.6 b) , 13.6 c)
4.1 d) 9.1, 13.6 b)
4.1 e) 8.6, 13.6 h)
4.1 f) 13.3 i)
4.1 g) 13.3 j)
4.1 h) 13.3 k)
4.1 i) 13.3 b), 13.6 i)
4.1 j) 13.6 k)
4.1 l) 9.1, 13.6 b)
4.1 o) 9.1, 13.6 b)
4.1 m) 13.6 c)
4.1 n) 13.6 n)
4.1 q) 13.6 i)
4.1 r), s) 13.6 d)
4.2 a) 13.2, 13.3 d), 13.5
4
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EN ISO 17510-2:2007 (E)
4.2 b) 13.2, 13.3 e), 13.4
4.2 c) 9.1
4.2 d) 8.7, 13.2, 13.3 c), 13.3 m)
4.2 e) 13.6 g)
5 4, 7.2, 7.5, 7.6
5.1 12.7.4
5.2 7.1, 7.3
5.3 9.2, 12.8.2
5.4 7.1, 7.3, 8.1, 8.3, 8.4, 8.5
5.5 9.2, 12.8.1, 12.8.2
5.6 8.1
6 12.7.2, 12.7.3
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
5
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INTERNATIONAL ISO
STANDARD 17510-2
Second edition
2007-10-01
Sleep apnoea breathing therapy —
Part 2:
Masks and application accessories
Thérapie respiratoire de l'apnée du sommeil —
Partie 2: Masques et accessoires d'application
Reference number
ISO 17510-2:2007(E)
©
ISO 2007
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ISO 17510-2:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 17510-2:2007(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
5 Construction requirements. 4
5.1 Mask connectors. 4
5.2 Biocompatibility. 4
5.3 * Protection against rebreathing . 5
5.4 Cleaning, disinfection and sterilization. 5
5.5 * Breathing during single fault condition . 5
5.6 Breathing system filter. 5
6 Vibration and noise. 6
Annex A (informative) Rationale . 7
Annex B (normative) Exhaust flow test procedure. 11
Annex C (normative) Resistance to flow (pressure drop). 13
Annex D (normative) Anti-asphyxia valve pressure testing . 15
Annex E (normative) Breathing during single fault condition — Determination of the inspiratory
and expiratory resistance . 17
Annex F (normative) CO rebreathing . 19
2
Annex G (normative) Vibration and noise . 22
Annex H (informative) Guide to information to be supplied by the manufacturer . 23
Annex I (informative) Reference to the essential principles. 24
Annex J (informative) Environmental aspects . 26
Annex K (informative) Terminology — Alphabetized index of defined terms. 27
Bibliography . 29
© ISO 2007 – All rights reserved iii
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ISO 17510-2:2007(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 17510-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This second edition cancels and replaces the first edition (ISO 17510-2:2003) which has been technically
revised.
ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing therapy :
⎯ Part 1: Sleep apnoea breathing therapy equipment
⎯ Part 2: Masks and application accessories
iv © ISO 2007 – All rights reserved
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ISO 17510-2:2007(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 document covers basic
safety and essential performance requirements needed to protect patients during use of this equipment.
ISO 17510-2 is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2
(1995), hereafter referred to as the General Standard. The General Standard is the basic document for the
safety of all medical electrical equipment used by or under the supervision of qualified personnel in the
general medical and patient environment; it also contains certain requirements for reliable operation to ensure
safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment,
such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc.
The Particular Standards apply to specific equipment types, such as medical electron accelerators, high
frequency surgical equipment, hospital beds, etc.
NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*).
© ISO 2007 – All rights reserved v
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INTERNATIONAL STANDARD ISO 17510-2:2007(E)
Sleep apnoea breathing therapy —
Part 2:
Masks and application accessories
1 Scope
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 3744:1994, Acoustics — Determination of sound power levels of noise sources using sound pressure —
Engineering method in an essentially free field over a reflecting plane
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 4871, Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 14937, 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 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17510-1:2007, Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment
© ISO 2007 – All rights reserved 1
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ISO 17510-2:2007(E)
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 23328-1, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to
assess filtration performance
ISO 23328-2, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance; Amendment A1:1991; Amendment A2:1995
IEC 60601-1-1:2000, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral
standard: Safety requirements for medical electrical systems
IEC 61672-1, 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, ISO 17510-1, ISO 17664,
ISO 23328-2, IEC 60601-1, IEC 60601-1-1 and the following apply.
NOTE For convenience, an alphabetized list of the sources of all defined terms used in this document is given in
Annex K.
3.1
anti-asphyxia valve
valve used on a naso-oral mask, which is open 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 accessories to atmosphere other than the leak due to improper seal to the
face
NOTE 1 The exhaust flow can pass through openings in the mask, the connecting element and the mask, or through
the anti-asphyxia valve.
NOTE 2 The exhaust flow discharges exhaled gases to atmosphere to reduce rebreathing of CO .
2
3.3
headgear
part that is used to fix the mask to the patient
3.4
mask
part which provides the interface between the patient and the patient connection port
NOTE According to their application, masks are divided into: nasal masks, oral masks or nasal-oral masks.
3.5
multi-patient re-use
capable of being re-used multiple times on multiple patients
3.6
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 2007 – All rights reserved
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ISO 17510-2:2007(E)
3.7
* patient connection port
port where the breathing gas pathway connects to the mask
3.8
single-patient reuse
capable of being used multiple times on the same patient
4 Information to be supplied by the manufacturer
NOTE Annex H contains a guide to assist the reader in locating the marking and labelling requirements contained in
other clauses of this part of ISO 17510.
4.1 The label of the packaging, marking on the mask or accessory, and/or the accompanying documents
shall contain the following information:
a) the name or trade name and address of the manufacturer and the name and address of the person
responsible or of the authorized representative of the manufacturer or importer;
b) the identity and intended purpose of the mask and any application accessories;
c) * the pressure-flow curve of the exhaust flow throughout the working pressure range as determined in
Annex B;
d) the rated pressure range of the mask including any connecting element;
e) if re-usable:
⎯ the information specified in ISO 17664:2004, 3.9, if sterilizable;
⎯ a warning that frequency of cleaning, methods of cleaning or the use of cleaning agents, other than
those specified in the accompanying documents, or exceeding the number of processing cycles can
have an adverse effect on the materials used or performance;
f) any special storage and/or handling conditions;
g) any special operating instructions;
h) any special warnings and/or precautions to be taken;
i) information necessary for correct assembly of the components if the packaging contains more than one
component;
j) information to enable the user (prescriber) to inform the patient of any potential contra-indications and any
precautions that might need to be taken;
k) a warning statement to the effect that occlusion of any exhaust port should be prevented;
l) * the resistance, derived from pressure drop, between mask and the patient connecting port at flowrates
of 50 l/min and 100 l/min, as determined in Annex C;
m) information about the means provided to minimize the risk of rebreathing (see 5.3);
n) a statement on proper disposal at end of life for the mask or accessory;
o) * the inspiratory and expiratory resistance of the mask in combination with the anti-asphyxia valve open
to atmosphere, as determined in Annex E;
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ISO 17510-2:2007(E)
p) expected service life of any masks and accessories;
q) the details of any further treatment or handling needed before the mask or accessory can be used;
r) the information needed to verify whether the mask or accessory is properly installed and can operate
correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed
to ensure that it operates properly and safely at all times;
s) information about the nature and frequency of regular and preventative maintenance of the mask or
accessory, including information about the replacement of consumable components of the device during
the intended life of the mask or accessory.
Check compliance by inspection of the accompanying documents.
4.2 If appropriate, the label of the packaging, marking on the mask or accessory, and/or the accompanying
documents shall contain the following information:
a) a serial number (or symbol 5.16 from ISO 15223-1:2007), or lot identifying number or batch identifying
number (or symbol 5.14 from ISO 15223-1:2007);
b) an indication (or symbol 5.12 from ISO 15223-1:2007) of the latest date by which the mask and any
application accessories can be used safely, expressed as the year and month;
c) a statement to the effect that combination with other medical devices can 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;
d) symbols 5.20 to 5.24 from ISO 15223-1:2007, if the package is sterile;
e) instructions necessary in the event of damage to the sterile packaging and details of appropriate methods
of resterilization.
Check compliance by inspection of the accompanying documents.
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 or
ISO 5356-2.
Non-conical mask connectors shall not engage with conical connectors conforming to ISO 5356-1 or
ISO 5356-2, unless they comply with the engagement, disengagement and leakage requirements of
ISO 5356-1 or ISO 5356-2.
Check compliance by inspection and functional testing.
5.2 Biocompatibility
Parts and/or materials that are intended to be in contact with the patient or patient gas pathway under normal
use shall comply with the ISO 10993 series. For nasal accessories intended to be inserted into the nares or
parts of masks intended to be inserted into the mouth, the external materials of the nasal inserts or of the
parts of the masks shall be evaluated as mucosal membrane contact. Additionally, for parts or materials not
intended to be inserted into nares or mouth, the gas pathway materials shall be evaluated as externally
communicating with tissue. For mask materials, including headgear, intended to contact the patient's head,
the materials shall be evaluated as skin contacting.
4 © ISO 2007 – All rights reserved
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ISO 17510-2:2007(E)
All materials shall be considered as for permanent duration contact as categorized in ISO 10993.
NOTE Permanent duration contact is required because sleep apnoea breathing therapy equipment and accessories
have cumulative usage that is greater than 30 days.
Latex shall not be used in the mask and accessories.
Check compliance by application of the ISO 10993 series.
5.3 * Protection against rebreathing
Means shall be provided to minimize the risk of rebreathing during normal condition and single fault condition.
Under normal condition, the relative CO increase shall not exceed 20 % when tested at the minimum rated,
2
5 hPa (5 cm H O), and 10 hPa (10 cm H O) pressure.
2 2
Under single fault condition, the relative CO increase shall not exceed 60 %.
2
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 re-use, 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 re-use shall be so constructed that
they can be cleaned and disinfected or cleaned and sterilized.
Processing or (re)processing methods for cleaning and disinfection of a mask shall consist of performing the
number of cleaning or cleaning and disinfection cycles that represents the expected lifetime of the mask.
Processing or (re)processing instructions disclosed in the instructions for use for the mask and any
accessories and their parts shall comply with ISO 17664 and ISO 14937. The mask and any accessories
labelled sterile shall have been sterilized using an appropriate, validated method as described in ISO 14937.
Non-sterile device packaging systems shall be designed to maintain products that are intended to be sterilized
before use at their intended level of cleanliness and shall be designed to minimize the risk of contamination.
Check compliance by review of the validation of the processing methods, including the verification that the
mask and any accessories and their parts comply with their specifications after re-processing and inspection
of instructions for use.
5.5 * Breathing during single fault condition
Means shall be provided to limit inspiratory and expiratory resistance in single fault condition. The resistance
to flow shall not exceed 10 hPa (10 cm H O) per l/s (measured at the patient connection port) at flowrates of
2
50 l/min.
If an anti-asphyxia valve is provided, the open-to-atmosphere pressure shall be less than the minimum rated
pressure of the mask. The open-to-atmosphere and closed-to-atmosphere pressures shall be disclosed in the
instructions for use.
Check compliance by using the tests described in Annexes D and E.
5.6 Breathing system filter
Any breathing system filter shall comply with ISO 23328-1 and ISO 23328-2.
Check compliance by application of the requirements of ISO 23328-1 and ISO 23328-2.
© ISO 2007 – All rights reserved 5
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ISO 17510-2:2007(E)
6 Vibration and noise
The A-weighted sound power level caused by the mask and any accessories shall be measured and dis
...
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