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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

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

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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
...

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—    ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
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NOTE 1       There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:
—    intended for use in the home healthcare environment;
NOTE 2     In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3     Such ventilatory support equipment can also be used in professional health care facilities.
—    intended for use by a lay operator;
—    intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
—    intended for transit-operable use; and
—    not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1        Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
This document does not specify the requirements for:
—    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilato

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

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

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

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

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

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

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