EN ISO 27427:2023
(Main)Anaesthetic and respiratory equipment - Nebulizing systems and components (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 anwendbar für:
a) Geräte, die für die nasale Ablagerung vorgesehen sind,
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)
Ta dokument določa zahteve glede varnosti in preskušanje učinkovitosti razprševalnih sistemov za splošno uporabo, ki so namenjeni stalnemu ali z vdihavanjem aktiviranemu dovajanju tekočin v aerosolni obliki prek dihalnega sistema.
Ta dokument vključuje nebulatorje s potisnim plinom, ki se lahko napajajo npr. prek kompresorjev, cevovodov, jeklenk itd., ter električne nebulatorje (npr. z vrtečim diskom, ultrazvočni, z vibrirajočo mrežico (aktivno ali pasivno) in kapilarne naprave) ali ročne nebulatorje. Ta dokument ne določa električnih zahtev za električne nebulatorje.
Ta dokument ne določa minimalne učinkovitosti razprševalnih sistemov.
Ta dokument se ne uporablja za:
a) pripomočke, namenjene za nosno odmerjanje;
b) pripomočke, ki so namenjeni izključno zagotavljanju vlaženja ali hidracije z zagotavljanjem vode v obliki aerosola.
OPOMBA 1: Te pripomočke obravnavata standarda ISO 80601-2-74 in ISO 20789.
c) nebulatorje za določena zdravila ali njihove sestavne dele (npr. inhalatorji z odmerjenimi odmerki, inhalatorji z odmerjenimi tekočinami, inhalatorji s suhim prahom).
OPOMBA 2: Te pripomočke obravnava standard ISO 20072.
OPOMBA 3: Za osnovno utemeljitev glej dodatek A.
General Information
Relations
Overview
EN ISO 27427:2023 - Anaesthetic and respiratory equipment: Nebulizing systems and components defines safety and performance testing for general-purpose nebulizing systems used to deliver liquids as aerosols to the human respiratory system. The standard covers continuous and breath‑actuated delivery and includes gas‑powered, electrically powered (e.g., spinning disc, ultrasonic, vibrating mesh - active and passive - and capillary) and manually powered nebulizers. It does not set minimum performance limits, nor does it cover electrical installation requirements for electrically powered devices. Exclusions include devices for nasal deposition, humidification-only devices, and drug‑specific inhalers.
Key topics and technical requirements
- Scope and device types: gas‑powered, electrically powered, and manual nebulizers for pulmonary delivery.
- Safety and performance testing: requirements for meaningful manufacturer test claims including aerosol output, aerosol output rate and particle sizing.
- Test methods and calibration: normative test procedures for aerosol output and particle size (see Annex C and D) and options for alternative test methods and calibration/setup.
- Materials and biocompatibility: selection of compatible, biocompatible materials for components exposed to liquids and patient interfaces.
- Design requirements: inlet/outlet ports, flow‑direction sensitive components, rotary controls, and features affecting cleaning, disinfection or sterilization.
- Packaging and sterile supply: requirements for devices supplied sterile and for packaging/marking.
- Information for users: required markings and instructions for use, including performance disclosures and driving gas supply information.
- Supporting annexes: rationale (Annex A), respirable particle diameters (Annex B), hazard identification for risk assessment (Annex E), and device classification (Annex F).
Applications and who uses this standard
EN ISO 27427:2023 is used by:
- Medical device manufacturers designing, validating or labeling nebulizing systems.
- Test laboratories and certification bodies performing performance and safety testing.
- Regulatory and quality teams assessing compliance and preparing technical documentation.
- Procurement and hospitals evaluating nebulizer suitability and interoperability.
- R&D and product engineers choosing materials, designing interfaces, and specifying cleaning/sterilization processes.
Practical benefits include clearer manufacturer performance claims, improved patient safety, device compatibility guidance, and harmonized test methods for aerosol output and particle sizing.
Related standards
- ISO 18190 - general standard for airway devices (format alignment; device‑specific rules in ISO 27427 take precedence).
- ISO 80601‑2‑74 and ISO 20789 - cover humidification and related devices.
- ISO 20072 - covers drug‑specific nebulizers and inhalers.
Keywords: EN ISO 27427:2023, nebulizing systems, nebulizers, aerosol delivery, particle sizing, safety and performance testing, vibrating mesh, ultrasonic nebulizer, gas‑powered nebulizer, biocompatibility, medical device testing.
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2023
Nadomešča:
SIST EN ISO 27427:2019
Anestezijska in dihalna oprema - Razprševalni sistemi in sestavni deli (ISO
27427:2023)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO
27427:2023)
Atemtherapiegeräte - Verneblersysteme und deren Bauteile (ISO 27427:2023)
Matériel d'anesthésie et de réanimation respiratoire - Systèmes de nébulisation et leurs
composants (ISO 27427:2023)
Ta slovenski standard je istoveten z: EN ISO 27427:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 27427
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 27427:2019
English Version
Anaesthetic and respiratory equipment - Nebulizing
systems and components (ISO 27427:2023)
Matériel d'anesthésie et de réanimation respiratoire - Atemtherapiegeräte - Verneblersysteme und deren
Systèmes de nébulisation et leurs composants (ISO Bauteile (ISO 27427:2023)
27427:2023)
This European Standard was approved by CEN on 3 March 2023.
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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 27427:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 27427:2023) 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
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 27427:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 27427:2023 has been approved by CEN as EN ISO 27427:2023 without any modification.
INTERNATIONAL ISO
STANDARD 27427
Fourth edition
2023-07
Anaesthetic and respiratory
equipment — Nebulizing systems and
components
Matériel d'anesthésie et de réanimation respiratoire — Systèmes de
nébulisation et leurs composants
Reference number
ISO 27427:2023(E)
ISO 27427:2023(E)
© ISO 2023
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 27427:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements and requirements for test . 3
4.1 General . 3
4.2 Test methods and alternatives . 4
4.2.1 Test methods for aerosol output, aerosol output rate, and particle sizing . 4
4.2.2 Alternative test methods . 4
4.2.3 Calibration and setup . 4
5 Materials . 4
5.1 General . 4
5.2 Biocompatibility . 4
6 Design Requirements.4
6.1 General . 4
6.2 Inlet and outlet ports . 5
6.2.1 Inlet ports . 5
6.2.2 Outlet port . 7
6.3 Flow-direction-sensitive components . 7
6.4 Cleaning and disinfection or sterilization . 7
6.5 Rotary controls . 7
7 Requirement for nebulizing systems and components supplied sterile .7
8 Packaging. 7
9 Information supplied by the manufacturer . 7
9.1 General . 7
9.2 Marking . 7
9.2.1 General . 7
9.2.2 Marking of the nebulizing system: . . 8
9.2.3 Marking on the packaging or individual pack . 8
9.3 Instructions for use . 9
9.3.1 General information . 9
9.3.2 Performance disclosures. 9
9.3.3 Driving gas supply information . 10
Annex A (informative) Rationale .11
Annex B (informative) Diameters of respirable fraction particles .15
Annex C (normative) Test methods for aerosol output and aerosol output rate .16
Annex D (normative) Test methods for particle sizing .19
Annex E (informative) Hazard identification for risk assessment .27
Annex F (informative) Classification of general-purpose nebulizers .30
Bibliography .32
iii
ISO 27427:2023(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 of the voluntary nature of standards, 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Airways and related equipment, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This fourth edition cancels and replaces the third edition (ISO 27427:2013), which has been technically
revised.
The main changes are as follows:
— Alignment with the general standard for airway devices, ISO 18190;
— updating of references.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 27427:2023(E)
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 are 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 is specified by the manufacturer and 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.
This document is written following the format of ISO 18190, which is the general standard for airways
and related equipment. The requirements in this device-specific standard take precedence over any
conflicting requirements in ISO 18190.
v
INTERNATIONAL STANDARD ISO 27427:2023(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 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 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 18190:2016, 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 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for breathing systems and driving gases applications
ISO 27427:2023(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
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
3.3
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
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
ISO 27427:2023(E)
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
parts, 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, 9.3.2 j) and k), Annex C, and Annex D.
3.19
test substance
active ingredient contained in the test solution
4 General requirements and requirements for test
4.1 General
ISO 18190:2016, Clause 4 applies.
NOTE See Annex E for a list of hazards than can be used as guidance in risk assessment.
ISO 27427:2023(E)
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
ISO 18190:2016, Clause 5 applies.
5.2 Biocompatibility
Materials used to manufacture nebulizing systems shall be evaluated for biocompatibility. The
breathing gas pathways shall be evaluated for biocompatibility as specified in ISO 18562-1 and tested
as appropriate.
Check conformance by inspection of the technical file/documentation.
6 Design Requirements
6.1 General
ISO 18190:2016, Clause 6 applies.
ISO 27427:2023(E)
6.2 Inlet and outlet ports
6.2.1 Inlet ports
The driving gas inlet port 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) a socket R2 connector conforming to ISO 80369-2; or
b) permanently attached (i.e. not removable without the use of a tool).
Check conformance by inspection of the technical file/documentation.
ISO 27427:2023(E)
Key
1 terminal unit conforming to ISO 9170-1
2 probe, conforming to ISO 9170-1
3 flow meter conforming to ISO 15002
4 body of 9/16 UNF DISS connector conforming to CGA V-5-2008, or body of 3/4 UNF DISS connector conforming
to CGA V-5-2008 or a nipple conforming to ISO 17256
5 9/16-18UNF-2A-RH socket connector conforming to CGA V-5-2008 or 3/4-16UNF-2A-RH socket connector
conforming to CGA V-5-2008 or a funnel conforming to ISO 17256
6 permanently attached
7 nebulizer
8 cone R2 connector conforming to ISO 80369-2
9 socket R2 connector conforming to ISO 80369-2
10 pressure regulator conforming to ISO 10524-1
11 compressor conforming to this document (ISO 27427)
12 aerosol mask vented
13 breathing tube conforming to ISO 5367
14 connector conforming to ISO 5356-1
15 T-piece with connectors conforming to ISO 5356-1
16 mouthpiece
17 tracheal tube conforming to ISO 5361
18 HME conforming to ISO 9360-1
a
To the patient.
Figure 1 — Examples of inlet and outlet ports for nebulizer systems
ISO 27427:2023(E)
6.2.2 Outlet port
6.2.2.1 If intended for use in breathing systems, the aerosol outlet port shall conform to ISO 5356-1.
Check conformance by inspection of the technical file/documentation.
6.2.2.2 If not intended for use in breathing systems, the aerosol outlet port shall not misconnect with
connectors conforming to ISO 5356-1, or ISO 80369-1.
Check conformance by inspection of the technical file/documentation.
6.3 Flow-direction-sensitive components
Any flow-direction-sensitive, operator-detachable component shall be designed so that it cannot be
fitted in such a way as to present a hazard to the patient.
Check conformance by functional testing.
6.4 Cleaning and disinfection or sterilization
Nebulizing systems and components intended for reuse shall be constructed so as to enable dismantling
for cleaning and disinfection or sterilization.
NOTE See also ISO 17664 -1.
Check conformance by testing the disassembly/assembly procedure according to the manufacturer's
instructions.
6.5 Rotary controls
The manufacturer should ensure consistency regarding the direction of movement of rotary controls of
the device.
7 Requirement for nebulizing systems and components supplied sterile
ISO 18190:2016, Clause 7 applies.
8 Packaging
ISO 18190:2016, Clause 8 applies.
9 Information supplied by the manufacturer
9.1 General
ISO 18190:2016, Clause 9 applies.
9.2 Marking
9.2.1 General
9.2.1.1 Marking shall be durable following exposure to typical substances in contact during its
intended use and remain legible for the intended duration of use.
ISO 27427:2023(E)
NOTE The durability requirements for markings that are exposed to saliva or mucus over a prolonged period
differ from the durability requirements for markings that are not exposed to prolonged exposure. Also, certain
markings might not be exposed to saliva or mucus but can come in intermittent contact with the skin oil.
Check compliance by exposing the appropriate marking areas of the product to the applicable substances
listed for a cumulative duration of time equivalent to the expected exposure duration in use:
— Drugs or chemicals which will contact the product in use and are listed in the Instructions for Use
(IFU).
— If applicable, artificial saliva
— If applicable, artificial mucus
— If applicable, artificial skin oil
9.2.1.2 Marking shall be legible after cleaning to the manufacturer’s instructions.
9.2.2 Marking of the nebulizing system:
The following shall be marked either on the nebulizer or its components as applicable:
a) an arrow showing the direction of gas flow on all operator-detachable flow-direction-sensitive
components, breathing attachments or parts (e.g. facemask or mouthpiece one-way valve, etc.),
unless manufactured to prevent incorrect assembly;
NOTE See 6.3 Flow-direction sensitive components
b) the maximum fill volume on the liquid container.
If applicable, controls and instruments shall be legibly marked with:
a) the gas supply pressures in kilopascals (kPa);
b) the pressures in breathing systems in hectopascals (hPa);
c) the flow in litres per minute (l/min);
d) the air entrainment/oxygen dilution valves, in percent oxygen (% O );
and
e) the power and/or control devices marked with the relevant symbols.
Check conformance by inspection.
9.2.3 Marking on the packaging or individual pack
In addition to the marking requirements specified in 9.2, the packaging or individual pack shall:
a) differentiate between the same or similar products, both sterile and non-sterile, placed on the
market by the same manufacturer;
b) for nebulizing systems intended to be connected to an electrical power source be marked with the
nominal power expressed in Watts (W) or kilowatts (kW), as appropriate;
c) for nebulizing systems intended to be connected to the supply mains be marked with the rated
supply voltage(s) or rated voltage range(s) to which they can be connected, expressed in Volts (V).
Check conformance by inspection.
ISO 27427:2023(E)
9.3 Instructions for use
9.3.1 General information
In addition to the marking requirements specified in 9.2, components of nebulizing systems, shall be
accompanied by instructions for use, inserts, or accompanying documents that include:
a) a statement that the nebulizing system is or is not suitable for use in an anaesthetic breathing
system or a ventilator breathing system. See ISO 80601-2-12 and ISO 80601-2-13;
b) if applicable, the maximum temperature above ambient reached in the liquid chamber under all
operating conditions;
c) the types of liquid (e.g. solution, suspension and/or emulsion) the device is designed to nebulize;
d) the maximum fill volume;
e) if appropriate, the recommended fill volume for use;
f) if applicable, an indication of the spatial orientation (e.g. vertical, horizontal, inverted) at which the
nebulizer functions as intended;
g) a warning to the effect that using a solution, suspension, or emulsion different from that
recommended by the manufacturer, in particular, a suspension and/or high-viscosity solution,
can alter the particle size distribution curve, the mass median aerodynamic diameter (MMAD),
aerosol output, and/or aerosol output rate, which can then be different from those disclosed by the
manufacturer;
h) a statement that nebulizing systems intended to be connected to a power source (electrical or
pneumatic) shall be disconnected from the power source after use;
i) the mass of the nebulizer system in kilograms (kg);
j) the expected service lifetime of the reusable parts.
9.3.2 Performance disclosures
a) a statement to the effect that the following disclosures for performance are based upon testing that
utilizes adult ventilatory patterns and are likely to be different from those stated for paediatric or
infant populations;
b) the distribution of particles, in terms of percent of sampled mass, within each of the following size
ranges: % >5 µm, % 2 µm to 5 µm, and % <2 µm as outlined in Annex B when tested in accordance
with Annex D;
c) the mass median aerodynamic diameter (MMAD) and the geometric standard deviation (GSD) only
if the distribution is unimodal and log-normal, as derived from the particle size distribution curve,
when tested in accordance with Annex D;
d) the respirable fraction performance of the nebulizer, when tested in accordance with Annex D;
e) the aerosol output and aerosol output rate at the fill volume recommended by the manufacturer or
2 ml if a recommended fill volume is not provided, expressed as the mass of test substance collected
and the mass of test substance collected per minute, when tested in accordance with Annex C;
f) for gas-powered nebulizers, the aerosol output and aerosol output rate at the minimum, nominal, and
maximum driving gas flows with the corresponding pressures, when tested in accordance with
Annex C;
g) the percentage of fill volume emitted per minute (e.g. 20 % of fill volume per minute) as the aerosol
output in one minute divided by the fill volume recommended by the manufacturer or 2 ml if no fill
volume is recommended, when tested in accordance with Annex C;
ISO 27427:2023(E)
h) for gas-powered nebulizers, the percentage of fill volume emitted and percentage of fill volume emitted
per minute at the minimum, nominal, and maximum driving gas flows with the corresponding
pressures, when tested in accordance with Annex C;
i) the residual volume (in millilitres), when tested in accordance with Annex C;
NOTE Aerosol output fraction can then be calculated as the aerosol output divided by the mass of the
liquid placed in the nebulizer.
j) the test solution used to carry out the nebulizer performance type-tests in Annexes C and D;
k) if alternative test methods or test solutions have been used to demonstrate nebulizer performance, a
demonstration of equivalency shall be included in the technical documentation of the manufacturer
and shall be made available upon request;
l) for breath-actuated nebulizers, the method of operation and relevant sensitivity;
m) the maximum A-weighted sound pressure level, as derived from the test method in
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 9.6.2.1;
n) for nebulizers intended for use with ventilators, a statement to the effect that the measured aerosol
output and aerosol output rate are not intended to be used as the basis to determine the correct
dosage and that the aerosol output can differ when the nebulizer is used in combination with a
ventilator.
9.3.3 Driving gas supply information
a) the recommended driving gas(es);
b) the minimum and maximum recommended driving gas pressures and flows;
c) if applicable, a warning that oxygen or oxygen mixtures (with the O > 23 %) should not be used as
[19]
the driving gas ;
d) if applicable, the composition and dryness specification for all gases to be supplied to the nebulizer;
ISO 27427:2023(E)
Annex A
(informative)
Rationale
A.1 General
This annex provides a concise rationale for the important requirements of this document and is intended
for use by those who are familiar with the subject of this document but who have not participated in
its development. An understanding of the reasons for the main requirements is considered essential
for its proper application. Furthermore, as clinical practices and technologies change, it is believed that
rationales for the present requirements will facilitate any revisions of this document necessitated by
those developments.
A.2 Rationale for Clause 1 — Scope
The essence of this document is to describe the characteristics and requirements of a general-purpose
nebulizer that can be used with a variety of medicinal substances. It is expected that the selection of
the nebulizer will be based on the requirements and characteristics developed in this document and
declared in the manufacturer's instructions for use.
Nasal deposition devices are excluded, as they are not considered general-purpose nebulizers.
There can be times when a device falls under the scope of either this document or ISO 20072. The
committee envisioned that the intended use of the product and the risk assessment of the device will
determine which standard the manufacturer chooses to qualify the device.
General-purpose nebulizers are considered to be semi-critical devices. Semi-critical devices are devices
that contact intact mucous membranes or non-intact skin. They do not ordinarily penetrate tissues or
otherwise enter normally sterile areas of the body. These devices should be reprocessed to be free from
all microorganisms.
A.3 Rationale for aerosol outlet port (3.3)
Mass is directly traceable to the active ingredient which is the fundamental deliverable. Volume is a
secondary measure because it is dependent on evaporation (see A.4).
A.4 Rationale for aerosol output rate (3.4)
The aerosol output rate can be greatly influenced by the evaporation of the aerosol droplets. The
following is provided to explain the sources and types of evaporation associated with nebulized aerosol:
Type 1 evaporation: Evaporation inside jet nebulizers. Compressed air (which is dry and on re-expansion
to atmosphere is always dry) draws up and mixes with nebulizer liquid container solution sprayed
within the nebulizer. The residence time of the de-compressed air (flow e.g. 6 l/min or 0,1 l/s) within
the nebulizer (internal volume, approximately 100 ml) is short (around 1/10 of a second). Even so, the
massive wet surface area of aerosol and rapid evaporation of solvent to the decompressed air ensures
that the air leaving the nebulizer is nearly saturated with water vapour (approximately 100 %). Further,
because of the latent heat lost to evaporation, the nebulizer liquid container cools relative to its initial
ambient temperature (from 20 °C to approximately 10 °C) and the aerosol-laden air leaves the nebulizer
in this cooled state. In this cooled saturated air cloud, the nebulized aerosol is stable until it either mixes
with ambient air (see Type 2 evaporation) or increases in temperature (see Type 3 evaporation).
ISO 27427:2023(E)
Type 2 evaporation: Evaporation of nebulized aerosol solvent when mixed with ambient air. Nebulized
aerosol leaving a jet or ultrasonic nebulizer exists in a cloud of 100 % relative humidity (RH) air. This
aerosol cloud is relatively stable with regard to evaporation until it mixes with ambient air. Mixing
is inherent in the design of constant output nebulizers where the nebulized aerosol is emitted into a
T-piece where the patient’s inhalation flow causes ambient air at lower humidity to be drawn into the
T-piece. The ambient air mixes with the nebulized aerosol-laden air and temporarily reduces the relative
humidity. The relative humidity quickly rises to 100 % by evaporation of water from the nebulized
aerosol. This evaporation effectively occurs in milliseconds, or using another reference, this evaporation
happens by the time the aerosol passes through the T-piece and tubing and exits from the nebulizer (or
very shortly thereafter). Of course, this volume loss implies that the size distribution of the nebulized
aerosol has shifted downwards. Further, this shift could not be constant, as smaller droplets have the
propensity to evaporate more readily than larger ones, so the distribution shift is not homogenous. In
any case, after the nebulized aerosol gives up solvent to re-saturate the air, the nebulized aerosol is again
stable. It is important to note that this form of evaporation is a feature of constant output nebulizers and
not “breath-enhanced nebulizers” whose design causes entrained ambient air to draw solvent vapour
from the nebulizer liquid container. For constant output nebulizers, the drier the ambient air, the greater
the effect of evaporation on the nebulized aerosol. Further, the lower the rate of aerosol output relative
to the flow of ambient air, the greater the effect of this evaporation on the nebulized aerosol.
Type 3 evaporation: Evaporation of nebulized aerosol solvent within a cascade impactor. Nebulized
aerosol, after mixing with ambient air, equilibrates to 100 % RH and is relatively stable. However, it
is cool (e.g. 10 °C) due to the latent heat of evaporation. The cool stable nebulized aerosol passes into
a cascade impactor. If the cascade impactor is at ambient temperature (e.g. 20 °C), the cooled air is
in contact with the cascade, which can act like a kind of radiator warming up the nebulized aerosol-
laden air. As the air warms up and travels through the cascade, the capacity of the warmer air to hold
moisture increases. In order to maintain 100 % RH, further evaporation occurs from the nebulized
aerosol during its flight through the cascade. As with the type 2 evaporation, the smaller the size of the
[24]
particles in the nebulized aerosol, the more significant the losses and the greater the size change.
A.5 Rationale for percentage of fill volume emitted (3.15)
The percentage of fill volume emitted is an important value to be disclosed to the user, because it can
influence the decisions of dosage intended for delivery in terms related to the expected amount of drug
given to the patient.
The percentage of fill volume emitted per minute, when expressed as a rate, is an important value to
disclose to the user, because it can influence the decisions of dosage intended for delivery in terms
related to the expected duration of the therapy.
A.6 Rationale for residu
...
Frequently Asked Questions
EN ISO 27427:2023 is a standard published by the European Committee for Standardization (CEN). Its full title is "Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)". This standard covers: 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.
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.
EN ISO 27427:2023 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 27427:2023 has the following relationships with other standards: It is inter standard links to EN ISO 27427:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 27427:2023 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
EN ISO 27427:2023は、一般的な用途のネブライザーシステムの安全性と性能テストに関する要求事項を明確に定めています。この標準は、呼吸器系を通じて人間に液体をエアロゾル形態で供給するための連続的または呼吸駆動型のネブライザーシステムに焦点を当てています。 この文書の強みは、ガス駆動型ネブライザーや電動ネブライザー（例：スピニングディスク、超音波、振動メッシュ、キャピラリーデバイス）、さらには手動駆動型ネブライザーを含むことで、多様なネブライザー技術に対応している点です。特に、医療向けの機器において、安全性が最優先されるため、これに対する具体的な要求事項を設けることで、患者の安全を確保しています。 また、EN ISO 27427:2023は、電動ネブライザーの電気的要件や、ネブライザーシステムの最小性能については規定していないため、これらは他の関連標準（例：ISO 80601-2-74やISO 20072）に任せられます。このアプローチにより、評価基準の明確なフレームワークが提供され、専門家が他の文書を参照することで、より包括的な理解を深めることができます。 さらに、この標準は、特定の用途（例：鼻に特化したデバイスや加湿器）の機器には適用されないことを明らかにし、ネブライザー技術の目的と適用範囲を具体的に定義しています。これにより、誤解を避け、関連する機器との整合性を保つことが可能となっています。 EN ISO 27427:2023は、医療分野におけるネブライザーの安全性と性能を向上させるための効果的な基準となり、特に呼吸器治療における重要な役割を果たしています。この標準は、新しい技術の進展にも対応可能であり、今後の医療機器の発展においても重要な指針となるでしょう。
Die Norm EN ISO 27427:2023 beschreibt Anforderungen für die Sicherheit und Leistungsprüfung von allgemeinen Nebelgeräten, die für die kontinuierliche oder atemgesteuerte Abgabe von Flüssigkeiten in aerosolform an Menschen durch das Atmungssystem bestimmt sind. Der Umfang dieser Norm ist klar definiert und schließt sowohl gasbetriebene als auch elektrisch betriebene Nebelgeräte ein, darunter auch innovative Technologien wie drehende Scheiben, Ultraschall- und vibrierende Netze, sowie manuell betriebene Nebelgeräte. Ein wesentliches Merkmal der Norm ist ihre Fokussierung auf die praktischen Anwendungen von Nebelgeräten im Gesundheitswesen, insbesondere in der Anästhesie und Atemtherapie. Die Klarheit der Richtlinien zur Sicherheit und Leistungsprüfung erhöht die Vertraulichkeit und das Vertrauen in die verwendetet Geräte, was für die Patientensicherheit von entscheidender Bedeutung ist. Die Norm behandelt nicht die elektrischen Anforderungen von elektrisch betriebenen Nebelgeräten, was ihre Anwendbarkeit in bestimmten technologischen Kontexten einschränkt, aber auch eine gezielte Anwendung der Normen ermöglicht. Die Festlegung, dass die Norm nicht für Geräte gilt, die nur zur Nasaldeposition oder zur Bereitstellung von Feuchtigkeit in aerosolform gedacht sind, sorgt dafür, dass der Fokus auf den relevanten Nebelgeräten bleibt. Darüber hinaus wird klargestellt, dass spezifische Arzneimittelnebelgeräte und deren Komponenten nicht abgedeckt sind, was durch die Verweis auf verwandte Normen wie die ISO 80601-2-74 und ISO 20072 unterstützt wird. Insgesamt ist die EN ISO 27427:2023 eine wichtige Norm, die durch ihre klaren Anwendungsrichtlinien und Sicherheitsanforderungen an die Nebelgeräte zur Unterstützung der Patientenversorgung in der Respiratorik und Anästhesie beiträgt. Die Relevanz dieser Norm in der modernen Medizintechnologie kann nicht unterschätzt werden, da sie zur Verbesserung der Behandlungsstandards und zur Gewährleistung der Gerätequalität beiträgt.
La norme SIST EN ISO 27427:2023, qui concerne les équipements anesthésiques et respiratoires, ainsi que les systèmes et composants de nébulisation, est d'une grande importance dans le domaine de la santé. Son domaine d'application est clairement défini, spécifiant les exigences relatives à la sécurité et aux tests de performance des systèmes de nébulisation à usage général, permettant la livraison de liquides sous forme d'aérosol à des patients via le système respiratoire. Parmi les points forts de cette norme, on note son inclusivité, englobant divers types de nébulisateurs, qu'ils soient alimentés par gaz ou électriquement, ainsi que ceux qui sont manuellement propulsés. Ceci garantit une large application des méthodes de nébulisation dans les environnements cliniques, en assurant la sécurité des utilisateurs et des patients. La norme se distingue également par sa clarté concernant les limites de son application. En précisant qu'elle ne couvre pas les exigences électriques des nébulisateurs électriques ni les systèmes à performance minimale, elle contribue à réduire la confusion sur les dispositifs inclus. De plus, elle exclusion des appareils destinés à la déposition nasale ou ceux uniquement destinés à humidifier, ce qui renforce sa précision et sa pertinence. Les références aux normes ISO 80601-2-74 et ISO 20072 pour les dispositifs spécifiques renforcent son cadre réglementaire, montrant ainsi une interconnexion avec d'autres documents standards, ce qui est essentiel pour une compréhension complète des exigences de sécurité et de performance dans le domaine de la nébulisation. En conclusion, la norme EN ISO 27427:2023 est un document essentiel qui répond aux besoins de sécurité et de performance des systèmes de nébulisation. Son approche précise et sa répartition méthodique des types de nébulisateurs assurent la protection et l'efficacité des traitements par aérosol, rendant cette norme particulièrement pertinente pour les professionnels de la santé.
The EN ISO 27427:2023 standard provides a comprehensive framework for the safety and performance testing of general-purpose nebulizing systems aimed at delivering liquids in aerosol form for respiratory applications. Its scope specifically includes a variety of nebulizers-gas-powered, electrically powered, and manually powered-each made for continuous or breath-actuated aerosol delivery. By categorically detailing the requirements for these nebulizing systems, this standard ensures a higher level of safety and performance across varied applications. One of the key strengths of this standard lies in its inclusivity of diverse types of nebulizing systems, encompassing those powered by compressors, pipeline systems, and more advanced technologies like ultrasonic and vibrating mesh devices. This breadth of coverage guarantees that the testing requirements apply across a wide range of products, which is crucial for manufacturers seeking to adhere to best practices in the industry. Furthermore, the document provides clear exclusions, which allows manufacturers and stakeholders to easily identify which devices do not fall under its purview, thus avoiding any regulatory confusion. However, the standard does not address the minimum performance benchmarks for nebulizing systems. While this can be perceived as a limitation, it does allow flexibility for innovation and adaptation in the industry, which can lead to the development of new technologies and approaches to nebulization. The EN ISO 27427:2023 standard's relevance cannot be overstated, given the increasing focus on respiratory therapies and the need for reliable nebulizing systems in clinical and home settings. As the healthcare landscape continues to evolve, the demand for standardization in medical equipment is paramount, ensuring not only patient safety but also enhancing clinical efficacy. Thus, this document stands as a significant contribution to the field of anaesthetic and respiratory equipment, guiding manufacturers in the design and testing of effective nebulizing solutions.
SIST EN ISO 27427:2023 표준은 호흡기 시스템을 통한 액체의 에어로졸 형태를 지속적으로 또는 호흡에 맞춰 전달하기 위한 일반적인 목적의 네뷸라이징 시스템의 안전성 및 성능 테스트 요건을 상세히 규정하고 있습니다. 이 문서는 가스 동력 네뷸라이저(예: 압축기, 배관 시스템, 실린더 등으로 동작하는 네뷸라이저) 및 전기적으로 구동되는 네뷸라이저(예: 회전 디스크, 초음파, 진동 메쉬(능동 및 수동), 모세관 장치)뿐만 아니라 수동으로 작동하는 네뷸라이저를 포함합니다. 본 표준의 강점은 네뷸라이저의 성능이나 전기적 요구사항을 명시하지 않음으로써 업계에 넓은 적용 범위를 제공한다는 점입니다. 또한, 네뷸라이저를 통해 전달되는 액체의 안전성과 효율성을 높이는 방향으로 설계되었습니다. 이는 사용자가 다양한 유형의 네뷸라이저를 선택하고 활용하는 데 있어 신뢰할 수 있는 기준을 제시하게 됩니다. 또한, SIST EN ISO 27427:2023 표준은 비강 침착을 위한 장치나 단순히 가습 혹은 수분 공급을 위한 장치에 대한 규정을 제외함으로써 특정 장치에 대한 요구사항을 명확히 하여, 사용자가 필요로 하는 정확한 정보를 제공하는 데 기여합니다. 약물 특화 네뷸라이저와 그 구성 요소에 대해서도 별도로 규정된 다른 표준(ISO 20072 등)을 통해 각기 다른 장비의 요구사항이 혼동되지 않도록 명확한 기초를 제공합니다. 결론적으로, SIST EN ISO 27427:2023 표준은 안전하고 효과적인 네뷸라이징 시스템을 위한 지침을 제공하며, 의료 기기 분야에서의 중요성이 매우 크고, 사용자 및 개발자 모두에게 수용 가능한 실용적인 기준을 제공합니다. 이는 안전하고 신뢰할 수 있는 헬스케어 환경을 조성하는 데 중요한 단초가 될 것입니다.
記事のタイトル：EN ISO 27427:2023 - 麻酔および呼吸器具-ネブライザシステムおよびコンポーネント（ISO 27427:2023 記事内容：この文書は、連続的または呼吸による液体のエアゾール状の人間への供給を目的とした汎用のネブライザシステムの安全性と性能テストの要件を規定しています。 この文書では、ガス駆動のネブライザ（圧縮機、パイプラインシステム、シリンダなどで駆動される）および電気駆動のネブライザ（回転ディスク、超音波、振動メッシュ（能動および受動）、毛細管デバイスなど）または手動駆動のネブライザを指します。ただし、この文書では、電気駆動のネブライザの電気要件やネブライザシステムの最小性能は指定されていません。 また、この文書は以下に該当しません： a）鼻への注入を目的とした装置； b）水のエアゾール形態で加湿または湿潤を提供するだけの装置。 注1：ISO 80601-2-74およびISO 20789がこれらのデバイスをカバーします。 c）特定の薬剤に適したネブライザまたはその構成部品（例：噴霧式吸入器、液体計量式吸入器、ドライパウダー吸入器）。 注2：ISO 20072がこれらのデバイスをカバーします。 注3：根拠については、付録Aを参照してください。
기사 제목: EN ISO 27427: 2023 - 마취 및 호흡 장비 - 인화 기계 및 구성 요소 (ISO 27427: 2023) 기사 내용: 이 문서는 일반 목적의 용액을 연속적이거나 호흡에 따라 분사하여 인체의 호흡 기계를 통해 인체에 액체를 분사하는 네뷸라이징 시스템의 안전성과 성능 시험 요건을 명시합니다. 이 문서에는 가스 구동 네뷸라이저 (컴프레서, 배관 시스템, 실린더 등으로 구동될 수 있음)와 전기 구동 네뷸라이저 [회전 디스크, 초음파, 진동 메쉬 (능동 및 수동), 그리고 모사 기기] 또는 수동 네뷸라이저를 포함합니다. 이 문서는 전기 구동 네뷸라이저의 전기 요구 사항을 지정하지 않습니다. 이 문서는 네뷸라이징 시스템의 최소 성능을 명시하지 않습니다. 이 문서는 다음에 해당하지 않습니다: a) 콧등에 사용되는 장치; b) 수분 증발 또는 수분 공급을 위한 수분화 장치로 단독으로 사용되는 장치. 참고1: ISO 80601-2-74 및 ISO 20789이 이러한 장치를 다룹니다. c) 약물 특정 네뷸라이저 또는 해당 구성 요소 (ex. 계량제 인허페어, 계량 액제 인허페어, 건조 분말 인허페어). 참고2: ISO 20072가 이러한 장치를 다룹니다. 참고3: 근거는 부록 A를 참조하십시오.
The article discusses the requirements for the safety and performance testing of general-purpose nebulizing systems used for delivering liquids in aerosol form to humans through the respiratory system. This includes both gas-powered and electrically powered nebulizers. The document does not specify the electrical requirements for electrically powered nebulizers or the minimum performance of nebulizing systems. It also does not cover devices intended for nasal deposition, devices used solely for humidification or hydration, or drug-specific nebulizers and their components. ISO standards are referenced for these specific devices. Annex A provides additional information and rationale.
The article discusses EN ISO 27427:2023, which sets requirements for the safety and performance testing of general-purpose nebulizing systems used for delivering liquids in aerosol form to humans through the respiratory system. This includes gas-powered and electrically powered nebulizers. However, the document does not specify the electrical requirements for electrically powered nebulizers or the minimum performance of nebulizing systems. It also excludes devices intended for nasal deposition, devices for humidification or hydration, and drug-specific nebulizers. ISO 80601-2-74, ISO 20789, and ISO 20072 cover these devices. Additional information can be found in Annex A.
해당 기사는 인체 호흡 계통을 통해 연속적이거나 호흡 반응으로 액체를 에어로졸 형태로 전달하는 일반용 Nebulizing 시스템의 안전성과 성능 시험 요구 사항을 명시하고 있습니다. 이 문서에는 가스로 작동되는 Nebulizers(예: 압축기, 파이프라인 시스템, 실린더 등으로 작동 가능한)와 전기로 작동되는 Nebulizers(예: 회전 디스크, 초음파, 진동 망(액티브 및 패시브), 모낭장치) 또는 수동으로 작동되는 Nebulizers를 포함합니다. 그러나 전기로 작동되는 Nebulizers의 전기 요구 사항을 정하지는 않았습니다. 또한, 이 문서에서는 Nebulizing 시스템의 최소 성능을 명시하지 않습니다. 또한 이 문서는 다음에 해당하는 경우에는 적용하지 않습니다: a) 콧구멍 침착을 위해 사용되는 장치 b) 수분화 또는 수분공급을 위해 물을 에어로졸 형태로 공급하는 장치에 사용되는 장치 c) 특정 약물에 대한 Nebulizers 또는 해당 부품 (예: 계량식 흡입기, 액체 계량식 흡입기, 건조 분말 흡입기) 이러한 특정 장치들에 대해서는 ISO 80601-2-74 및 ISO 20789, ISO 20072의 기준이 적용됩니다. 부록 A에서는 이에 대한 원리와 추가 정보가 제공됩니다.
この記事では、一般的なNebulizingシステムの安全性と性能テストの要件について説明しています。このシステムは、連続的または呼吸駆動によって液体をエアゾル形状で人体の呼吸器系に送信するためのものです。ガス駆動のNebulizers（圧縮機、パイプラインシステム、シリンダなどによって動力が供給されるもの）および電気駆動のNebulizers（スピニングディスク、超音波、振動メッシュ（アクティブおよびパッシブ）、キャピラリー装置など）または手動で動作するNebulizersも含まれます。ただし、電気駆動のNebulizersの電気要件は指定されていません。 また、このドキュメントでは、Nebulizingシステムの最低性能を指定していません。また、以下の項目には適用されません： a）鼻への使用を目的としたデバイス b）湿化または水分供給のための水をエアゾル形状で提供するのみに使用されるデバイス c）特定の薬剤に対するNebulizersまたはそのコンポーネント（計量吸入器、計量液体吸入器、ドライパウダー吸入器など） これらの特定のデバイスに関しては、ISO 80601-2-74およびISO 20789、ISO 20072の基準が適用されます。付録Aでは、これらの情報に関しての根拠や追加情報が提供されています。
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