EN ISO 27427:2023

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)

This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers.
This document does not specify the minimum performance of nebulizing systems.
This document does not apply to:
a)       devices intended for nasal deposition;
b)       devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE 1        ISO 80601-2-74 and ISO 20789 cover these devices.
c)        drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).
NOTE 2        ISO 20072 covers these devices.
NOTE 3        See Annex A for rationale.

Atemtherapiegeräte - Verneblersysteme und deren Bauteile (ISO 27427:2023)

Dieses Dokument legt Anforderungen für die Prüfung der Sicherheit und Leistung von Mehrzweck-Verneblersystemen fest, die für die kontinuierliche oder atmungsaktivierte Ausgabe von Flüssigkeiten in Form von Aerosolen an Menschen durch das Atmungssystem vorgesehen sind.
Dieses Dokument schließt gasbetriebene Vernebler (die z. B. mit Kompressoren, Rohrleitungssystemen, Gasflaschen usw. betrieben werden können) und elektrisch betriebene Vernebler [z. B. Drehscheibe, Ultraschall, vibrierende Mesh-Vernebler (aktiv und passiv) und Kapillargeräte] oder von Hand betriebene Vernebler ein. Dieses Dokument legt keine elektrischen Anforderungen an elektrisch betriebene Vernebler fest.
Dieses Dokument legt keine Mindestangaben für die Leistung von Verneblersystemen fest.
Dieses Dokument ist nicht anzuwenden für
a)   Geräte, die für die nasale Ablagerung vorgesehen sind, und
b)   Geräte, die ausschließlich für die Erzeugung von Feuchte oder für die Hydration durch Bereitstellung von Wasser in Form von Aerosolen vorgesehen sind.
ANMERKUNG 1   Diese Geräte werden von ISO 80601 2 74 und ISO 20789 abgedeckt.
c)   Vernebler für bestimmte Medikamente oder ihre Bauteile (z. B. Inhaliergeräte mit Dosierungen nach dem metrischen System, Flüssigkeits-Dosierinhaliergeräte, Trockenpulver-Inhaliergeräte).
ANMERKUNG 2   Diese Geräte werden von ISO 20072 abgedeckt.
ANMERKUNG 3   Siehe Anhang A für die Begründung.

Matériel d'anesthésie et de réanimation respiratoire - Systèmes de nébulisation et leurs composants (ISO 27427:2023)

Le présent document spécifie les exigences relatives à la sécurité, aux performances et aux essais des systèmes de nébulisation à usage général destinés à l’administration continue ou déclenchée par la respiration, sous forme d’un aérosol, de liquides aux personnes, via le système respiratoire.
Le présent document inclut les nébuliseurs pneumatiques qui peuvent être alimentés, par exemple par compresseurs, par réseau de gaz médicaux, par bouteilles, etc. ainsi que les nébuliseurs électriques [par exemple les dispositifs à disque rotatif, ultrasoniques, à tamis vibrant (actif et passif) et à capillaire] ou les nébuliseurs manuels. Le présent document ne spécifie pas les exigences électriques pour les nébuliseurs électriques.
Le présent document ne spécifie pas de performance minimale pour les systèmes de nébulisation.
Le présent document ne s’applique pas aux:
a)       dispositifs pour traitement nasal;
b)       dispositifs uniquement destinés à assurer une humidification ou une hydratation en fournissant de l’eau sous forme d’aérosol.
NOTE 1        L’ISO 80601-2-74 et l’ISO 20789 couvrent ces dispositifs.
c)        nébuliseurs spécifiques à des médicaments ou à leurs composants (par exemple aérosols doseurs, aérosols doseurs de liquide, inhalateurs à poudre sèche).
NOTE 2        L’ISO 20072 couvre ces dispositifs.
NOTE 3        Voir l’Annexe A pour les justifications.

Anestezijska in dihalna oprema - Razprševalni sistemi in sestavni deli (ISO 27427:2023)

General Information

• Status: Published
• Publication Date: 25-Jul-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 4 - Tracheal tubes and other equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 26-Jul-2023
• Completion Date: 26-Jul-2023
• Ref Project: SIST EN ISO 27427:2023 - Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)

Relations

• Replaces: EN ISO 27427:2019 - Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 27427:2021
01-maj-2021
Anestezijska in dihalna oprema - Razprševalni sistemi in sestavni deli (ISO/DIS
27427:2021)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO/DIS
27427:2021)
Atemtherapiegeräte - Verneblersysteme und deren Bauteile (ISO/DIS 27427:2021)
Matériel d'anesthésie et de réanimation respiratoire - Systèmes de nébulisation et ses
composants (ISO/DIS 27427:2021)
Ta slovenski standard je istoveten z: prEN ISO 27427
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 27427:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 27427:2021

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oSIST prEN ISO 27427:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 27427
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-03-19 2021-06-11
Anaesthetic and respiratory equipment — Nebulizing
systems and components
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 27427:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021

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oSIST prEN ISO 27427:2021
ISO/DIS 27427:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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oSIST prEN ISO 27427:2021
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 General requirements and requirements for test . 5
4.1 General . 5
4.2 Test methods and alternatives . 5
4.2.1 Test methods for aerosol output, aerosol output rate, and particle sizing . 5
4.2.2 *Alternative test methods . 5
4.2.3 Calibration and setup . 5
5 Materials . 5
5.1 General . 5
5.2 Biocompatibility . 5
6 Design Requirements . 6
6.1 General . 6
6.2 Connectors . 6
6.2.1 Driving gas inlet connectors . 6
6.2.2 Aerosol pathway connectors . 6
6.3 Flow-direction-sensitive components . 8
6.4 Cleaning and disinfection or sterilization . 8
6.5 Rotary controls. . 9
7 Requirement for nebulizing systems and components supplied sterile .9
8 Packaging . 9
9 Information supplied by the manufacturer . 9
9.1 General . 9
9.2 Marking . 9
9.2.1 General. 9
9.2.2 Marking of the nebulizer and other components: . 9
9.2.3 Marking on the packaging or individual pack .10
9.3 Instructions for use .10
9.3.1 General information .10
9.3.2 Performance disclosures.11
9.3.3 Driving gas supply information .11
Annex A (informative) Rationale .13
Annex B (normative) Diameters of respirable fraction particles .17
Annex C (normative) Test methods for aerosol output and aerosol output rate .18
Annex D (normative) Test methods for particle sizing .21
Annex E (informative) Hazard identification for risk assessment .29
Annex F (informative) Classification of general-purpose nebulizers .35
Annex G (informative) Environmental aspects .37
Bibliography .39
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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 World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airways and related equipment.
This document is written following the format of ISO 18190, General standard for airways and related
equipment. The requirements in this device-specific standard take precedence over any conflicting
requirements in the general standard.
This fourth edition cancels and replaces the third edition (ISO 27427:2013), of which it constitutes a
major revision. The main changes compared to the previous edition are as follows:
— Alignment with the general standard for airway devices, ISO 18190;
— updating of references.
Throughout this document 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: smaller
type. The normative text of tables is also in smaller type;
— terms defined in clause 3: italics
— Throughout this document, text for which rationale is provided in Annex A is indicated by
an asterisk (*).
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Introduction
Nebulizers are widely used to deliver drugs and vaccines in an aerosol form to humans through the
respiratory system. Nebulizers are also used for diagnostic purposes using radioisotopes for lung
challenge tests. These drugs can be in the form of a solution, suspension or emulsion. Aerosol inhalation
is the preferred route of administration for some drugs. Some drugs are intended for treatment of
systemic diseases and other drugs are intended to treat respiratory diseases. To achieve the intended
treatment, aerosol particles have to be deposited in specific parts of the respiratory tract. Different
size particles tend to deposit in different parts of the respiratory system; therefore, the performance
profile and the intended use of the nebulizer have to be defined by the manufacturer and specified in
the accompanying documentation.
This document was developed to cover “general purpose” nebulizers and is based on adult test
parameters which are likely to be different than stated when testing for paediatric or infant patient
populations. It was specifically written to ensure that the results of the various tests declared by the
manufacturer are meaningful to the users and buyers of nebulizers.
The objectives of this document are to ensure
— suitability of the nebulizers for the intended use as disclosed by the manufacturer;
— safety, particularly for electrically powered nebulizers;
— compatibility between the materials of the components and the dispensed liquid; and
— biocompatibility of the materials of the components that come into contact with the human body.
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oSIST prEN ISO 27427:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 27427:2021(E)
Anaesthetic and respiratory equipment — Nebulizing
systems and components
1 Scope
*This document specifies requirements for the safety and performance testing of general-purpose
nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to
humans through the respiratory system.
This document includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline
systems, cylinders, etc., and electrically powered nebulizers [e.g., spinning disc, ultrasonic, vibrating
mesh (active and passive), and capillary devices] or manually powered nebulizers.
This document does not specify the minimum performance of nebulizing systems.
*This document does not apply to:
a) devices intended for nasal deposition;
b) devices intended solely to provide humidification or hydration by providing water in aerosol form.
[3] [[4]]
NOTE ISO 80601-2-74 and ISO 20789 cover these devices.
*This document does not apply to drug-specific nebulizers or their components (e.g., metered dose
inhalers, metered liquid inhalers, dry powder inhalers).
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 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 10524-1, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure
regulators with flow-metering devices
ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with
cylinder valves (VIPRs)
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of
development, validation and routine control
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 17256, Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 18082, Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded
(NIST) low-pressure connectors for medical gases
ISO 18190, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 23328-1, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to
assess filtration performance
ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for breathing systems and driving gases applications
ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors
for enteral applications
ISO 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors
for limb cuff inflation applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
I EC 6 06 01-1-2:20 06 +A 1: 2012 , Medical electrical equipment — Part 1-2: General requirements for basic
safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements
and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance — Collateral standard: Usability
IEC 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
IEC 62366, Medical devices — Application of usability engineering to medical devices
EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
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EN 13544-2, Respiratory therapy equipment — Part 2: Tubing and connectors
EN 15908, Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-
pressure connectors for medical gases
ENV 737-6, Medical gas pipeline systems — Part 6: Dimensions and allocation of probes for terminal units
for compressed medical gases and vacuum
CGA V-5-2005, Diameter Index Safety System — Noninterchangeable Low Pressure Connections for Medical
Gas Applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aerosol
suspension of particles in gas
Note 1 to entry: Particles can be liquid or solid.
Note 2 to entry: The gas can be the driving gas or ambient air.
3.2
*aerosol output
mass or volume of aerosol emitted by the nebulizing system at the aerosol outlet port for the given
fill volume
3.2.1
aerosol outlet port
outlet of the nebulizing system through which the aerosol is emitted
3.3
aerosol outlet port
outlet of the nebulizing system through which the aerosol is emitted
3.4
*aerosol output rate
mass or volume of aerosol emitted by the nebulizing system per unit of time
3.5
breath-actuated nebulizer
nebulizer triggered by a respiratory parameter
Note 1 to entry: Examples of this classification are found in Annex F.
3.6
continuous nebulizer
nebulizer in which aerosol is delivered continuously over multiple inhalation/exhalation breathing
cycles or over long periods
3.7
electrically-powered nebulizer
nebulizer that operates by means of electrical power
Note 1 to entry: Electrically powered nebulizers include ultrasonic, vibrating mesh and capillary-type devices.
3.8
gas-powered nebulizer
nebulizer in which the aerosol is generated by compressed gas
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3.9
liquid container
part of the nebulizer that contains the liquid for nebulization
3.10
manually powered nebulizer
nebulizer that operates by means of human power
3.11
mass median aerodynamic diameter
MMAD
particle size at which 50 % of the mass of the active component are contained in droplets of smaller or
equal aerodynamic diameter
3.12
maximum fill volume
maximum volume of liquid, expressed in millilitres, in the liquid container when the nebulizer is filled to
its maximum filling level
3.13
nebulizer
device that converts a liquid to an aerosol
Note 1 to entry: A nebulizer is also known as an aerosol generator.
3.14
nebulizing system
device, including the nebulizer and all other components, up to and including the aerosol outlet port,
required to make the aerosol available for inhalation
Note 1 to entry: Airway devices (e.g., masks, tracheal and tracheostomy tubes, supralaryngeal airways) and
breathing systems are not part of the nebulizing system.
3.15
*percentage of fill volume emitted
aerosol output expressed as a percentage of the fill volume recommended by the manufacturer that is
emitted by the nebulizer
3.16
*residual volume
estimated volume of liquid remaining in the nebulizing system when the nebulizer stops generating
an aerosol
3.17
*respirable fraction
fraction of aerosol droplets below 5 μm in diameter expressed as a percentage of the total aerosol
distribution
Note 1 to entry: The respirable fraction can be converted to a percentage (%) by multiplying by 100.
3.18
*test solution
aqueous solution used for the type-tests to characterize aerosol output, aerosol output rate, and
particle sizing
Note 1 to entry: See 4.2.1.2, 5.4.2 j) and k), Annex C, and Annex D.
3.19
test substance
active ingredient contained in the test solution
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4 General requirements and requirements for test
4.1 General
The requirements of ISO 18190:2016 Clause 4 shall apply.
4.2 Test methods and alternatives
4.2.1 Test methods for aerosol output, aerosol output rate, and particle sizing
The type-test methods for aerosol output, aerosol output rate, and particle sizing in air are specified in
Annexes C and D.
4.2.1.1 *All type-test methods shall be performed on at least three representative devices of the
same type.
Check conformance by inspection of the technical file/documentation.
4.2.1.2 *The type-test methods shall use a test solution of albuterol 0,1 % (mass/mass or volume/
volume (m/m OR V/V)) concentration in 0,9 % sodium chloride solution or 2,5 % (m/m OR V/V) sodium
fluoride in distilled water with the provision that its use is declared in the accompanying documents. See
9.3.2 j).
Check conformance by inspection of the technical file/documentation and the accompanying documents.
4.2.2 *Alternative test methods
The manufacturer can use type-test methods for aerosol output, aerosol output rate, and particle sizing
different from those specified in Annexes C and D, provided that any:
a) alternative test methods are validated against the test methods in Annexes C and D to demonstrate
equivalency and that
b) the demonstration of equivalency is included in the technical documentation of the manufacturer.
Check conformance by inspection of the technical file/documentation.
4.2.3 Calibration and setup
To establish confidence in the test method, it is recommended that mass balance procedures be
incorporated during initial determinations. It is also recommended that occasional checks for system
leaks and overall efficiency of analysis be performed.
5 Materials
5.1 General
The applicable requirements of ISO 18190:2016 Clause 5 shall apply.
5.2 Biocompatibility
Materials used to manufacture nebulizers, nebulizing systems, and their components shall be evaluated
for biocompatibility. The breathing gas pathways shall be evaluated for biocopmatilibyt as specified in
ISO 18562-1:2017 and tested as appropriate.
Check conformance by inspection of the technical file/documentation.
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6 Design Requirements
6.1 General
The applicable requirements of ISO 18190:2016 Clause 6 shall apply.
6.2 Connectors
6.2.1 Driving gas inlet connectors
The driving gas inlet connector of a nebulizing system shall be compatible with the gas delivery system
to which it is intended to be connected and shall be one of the following (see Figure 1):
a) the nut and nipple of a non-interchangeable screw-threaded (NIST) connector complying with
ISO 18082;
b) the nut and nipple of a Diameter Index Safety System (DISS) connector complying with CGA V-5-2005;
c) a probe complying with ISO 9170-1, ENV 737-6, or the relevant national standard;
or
[26]
d) *a female R2 small-bore connector complying with ISO 80369-2 .
Check conformance by inspection of the technical file/documentation.
6.2.2 Aerosol pathway connectors
6.2.2.1 If intended for use in breathing systems, the nebulizing system connectors shall comply with
ISO 5356-1. It shall not be possible to attach the nebulizer outlet to any device in a manner that does not
allow an alternate pathway for exhalation. See Figure 2.
Check conformance by inspection of the technical file/documentation.
6.2.2.2 If not intended for use in breathing systems, the nebulizing system connectors shall not
misconnect with connectors complying with ISO 5356-1, or ISO 80369-parts 2, 3 5 and 7.
Check conformance by inspection of the technical file/documentation.
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Key
1 terminal unit complying with ISO 9170-1 [on a pressure regulator or on a Medical Gas Pipeline System (MGPS)]
2 probe, DISS, or NIST (see ISO 9170-1, ENV 737-6, or ISO 18082)
3 threaded connector (see ISO 17256)
4 respiratory connector (see ISO 17256 or ISO 80369-parts 2, 3 5 or 7)
5 hose (see ISO 17256)
[17]
6 flowmeter (see ISO 15002 )
7 nebulizer
8 pressure regulator (see ISO 10524-1)
9 com
...