SIST EN ISO 23402-3:2024
(Main)Dentistry - Portable dental equipment for use in non-permanent healthcare environment - Part 3: Portable suction equipment (ISO 23402-3:2024)
Dentistry - Portable dental equipment for use in non-permanent healthcare environment - Part 3: Portable suction equipment (ISO 23402-3:2024)
This document specifies terminology, classification, requirements and test methods for portable suction
equipment primarily intended to be used by dental professionals in non-permanent healthcare environments.
This document applies to portable suction equipment incorporated in a portable dental unit and freestanding
portable suction equipment.
The requirements in this document focus on portability.
This document specifies requirements for information to be supplied by the manufacturer on the
performance, operation and maintenance of portable suction equipment designed and constructed to be
transported for use in non-permanent healthcare environments. This document also specifies requirements
for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human
transport between non-permanent healthcare environments.
This document does not apply to stationary dental equipment, wearable equipment (such as headlamps
and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in nonpermanent
healthcare environments or not designed to be disassembled, folded or packed for human
transport between non-permanent healthcare environments. Also, requirements for stationary dental
equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile
dental clinic) are not considered in this document.
This document specifies requirements for portable suction equipment used to provide reduced pressure
and flow at the cannula connector.
This document does not apply to portable suction equipment used for life support or for scavenging
halogenated anaesthetic gases.
Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften Gesundheitseinrichtungen - Teil 3: Tragbare Absauggeräte (ISO 23402-3:2024)
Dieses Dokument legt die Terminologie, Klassifizierung, Anforderungen und Prüfverfahren für tragbare Absauggeräte fest, die in erster Linie für die Verwendung durch zahnärztliches Personal in einer nicht dauerhaften Gesundheitseinrichtung bestimmt sind.
Dieses Dokument gilt für tragbare Absauggeräte, die in eine tragbare dentale Behandlungseinheit eingebaut sind, und für frei stehende tragbare Absauggeräte.
Die Anforderungen in diesem Dokument konzentrieren sich auf die Tragbarkeit.
Dieses Dokument legt Anforderungen an die vom Hersteller bereitzustellenden Informationen über die Leistung, den Betrieb und die Wartung von tragbaren Absauggeräten fest, die für den Transport zur Verwendung in nicht-dauerhaften Gesundheitseinrichtungen ausgelegt und gebaut sind. Dieses Dokument legt außerdem die Anforderungen an die Anweisungen fest, die der Hersteller für das Zusammenbauen, Zerlegen und Verpacken für den Transport durch Personen zwischen nicht dauerhaften Gesundheitseinrichtungen bereitstellen muss.
Dieses Dokument gilt nicht für stationäre zahnärztliche Ausrüstung, tragbare Geräte (wie Stirnleuchten und Lupen), mobile dentale Ausrüstung oder tragbare dentale Ausrüstung, die nicht für die Verwendung in nicht-dauerhaften Gesundheitsumgebungen vorgesehen ist oder nicht dafür entwickelt wurde, für den menschlichen Transport zwischen nicht-dauerhaften Gesundheitsumgebungen zerlegt, zusammengefaltet oder verpackt zu werden. Zudem werden Anforderungen an stationäre zahnärztliche Ausrüstung, die in einer mobilen zahnärztlichen Einrichtung (z. B. mobile Zahnklinik in einem Fahrzeug oder einem Container) verbaut werden kann, in diesem Dokument nicht berücksichtigt.
Dieses Dokument legt die Anforderungen an tragbare Absauggeräte fest, die für einen reduzierten Druck und Durchfluss am Kanülenverbindungsstück verwendet werden.
Dieses Dokument gilt nicht für tragbare Absauggeräte, die zur Lebenserhaltung oder zum Absaugen von halogenierten Anästhesiegasen verwendet werden.
Médecine bucco-dentaire - Matériel dentaire portatif utilisable dans des environnements de soins de santé non permaments - Partie 3: Matériel d’aspiration portatif (ISO 23402-3:2024)
Le présent document spécifie la terminologie, la classification, les exigences et les méthodes d’essai applicables au matériel d’aspiration portatif principalement destiné à être utilisé par des dentistes dans des environnements de soins de santé non permanents.
Le présent document s’applique au matériel d’aspiration portatif intégré dans un unit dentaire portatif et dans le matériel d’aspiration portatif sur pied.
Les exigences spécifiées dans le présent document concernent la portabilité.
Le présent document spécifie les exigences relatives aux informations à fournir par le fabricant sur les performances, le fonctionnement et l’entretien du matériel d’aspiration portatif conçu et fabriqué pour être transporté pour être utilisé dans des environnements de soins de santé non permanents. Le présent document spécifie également les exigences relatives aux instructions à fournir par le fabricant sur l’assemblage, le démontage et l’emballage pour être transporté par des hommes entre des environnements de soins de santé non permanents.
Le présent document ne s’applique pas au matériel dentaire fixe, au matériel de poche (tel que les lampes frontales et les loupes), le matériel dentaire mobile ou le matériel dentaire portatif qui n’est pas destiné à être utilisé dans des environnements de soins de santé non permanents ou qui n’est pas conçu pour être démonté, plié ou rangé pour être transporté par des hommes entre des environnements de soins de santé non permanents. De plus, les exigences relatives au matériel dentaire fixe qui peut être installé dans un établissement médical dentaire mobile (par exemple, clinique dentaire mobile dans un véhicule ou un conteneur) ne sont pas abordées dans le présent document.
Le présent document spécifie les exigences applicables au matériel d’aspiration portatif utilisé pour fournir une pression et un débit réduits au niveau de raccord de canule.
Le présent document ne s’applique pas au matériel d’aspiration portatif utilisé pour le maintien artificiel des fonctions vitales ou pour l’évacuation des gaz anesthésiques halogénés.
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 3. del: Prenosna sukcijska (aspiracijska) oprema (ISO 23402-3:2024)
Ta dokument določa terminologijo, razvrščanje, zahteve in preskusne metode za prenosno sukcijsko (aspiracijsko) opremo, ki se uporablja predvsem v zobozdravstvu za začasno zdravstveno oskrbo.
Ta dokument se uporablja za prenosno sukcijsko (aspiracijsko) opremo, ki je vgrajena v prenosno dentalno enoto, in prostostoječo prenosno sukcijsko (aspiracijsko) opremo.
Zahteve v tem dokumentu se osredotočajo na prenosljivost.
Ta dokument določa zahteve glede informacij, ki jih mora zagotoviti proizvajalec o zmogljivosti, delovanju in vzdrževanju prenosne sukcijske (aspiracijske) opreme, zasnovane in izdelane za prenašanje v okviru začasne zdravstvene oskrbe. Določa tudi zahteve glede navodil, ki jih mora zagotoviti proizvajalec v zvezi s sestavljanjem, razstavljanjem in pakiranjem opreme, ki jo prenaša uporabnik med posameznimi okolji za začasno zdravstveno oskrbo.
Ta dokument se ne uporablja za stacionarno dentalno opremo, nosljivo opremo (npr. naglavne svetilke
in povečevalna stekla), mobilno dentalno opremo ali prenosno dentalno opremo, ki ni namenjena za začasno zdravstveno oskrbo oziroma je uporabnik ne more razstaviti, zložiti ali zapakirati in prenašati med posameznimi okolji za začasno zdravstveno oskrbo. Zahteve za stacionarno dentalno opremo, ki jo je mogoče namestiti v mobilno zobozdravstveno ambulanto (npr. v vozilu ali kontejnerju), prav tako niso zajete v tem dokumentu.
Ta dokument določa zahteve za prenosno sukcijsko (aspiracijsko) opremo, ki se uporablja za zagotavljanje nižjega tlaka in pretoka na priključku kanile.
Ta dokument se ne uporablja za prenosno sukcijsko (aspiracijsko) opremo, ki se uporablja za ohranjanje življenja ali za splakovanje
halogeniranih anestezijskih plinov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 3.
del: Prenosna sukcijska (aspiracijska) oprema (ISO 23402-3:2024)
Dentistry - Portable dental equipment for use in non-permanent healthcare environment -
Part 3: Portable suction equipment (ISO 23402-3:2024)
Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften
Gesundheitseinrichtungen - Teil 3: Tragbare Absauggeräte (ISO 23402-3:2024)
Médecine bucco-dentaire - Matériel dentaire portatif utilisable dans des environnements
de soins de santé non permaments - Partie 3: Matériel d’aspiration portatif (ISO 23402-
3:2024)
Ta slovenski standard je istoveten z: EN ISO 23402-3:2024
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23402-3
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Portable dental equipment for use in non-
permanent healthcare environment - Part 3: Portable
suction equipment (ISO 23402-3:2024)
Médecine bucco-dentaire - Matériel dentaire portatif Zahnheilkunde - Tragbare dentale Ausrüstung zur
utilisable dans des environnements de soins de santé Anwendung in nicht-dauerhaften
non permanents - Partie 3: Matériel d'aspiration Gesundheitseinrichtungen - Teil 3: Tragbare
portatif (ISO 23402-3:2024) Absauggeräte (ISO 23402-3:2024)
This European Standard was approved by CEN on 22 March 2024.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23402-3:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23402-3:2024) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
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 November 2024, and conflicting national standards
shall be withdrawn at the latest by November 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 has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
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 23402-3:2024 has been approved by CEN as EN ISO 23402-3:2024 without any
modification.
International
Standard
ISO 23402-3
First edition
Dentistry — Portable dental
2024-04
equipment for use in non‐
permanent healthcare
environment —
Part 3:
Portable suction equipment
Médecine bucco-dentaire — Matériel dentaire portatif utilisable
dans des environnements de soins de santé non permaments —
Partie 3: Matériel d’aspiration portatif
Reference number
ISO 23402-3:2024(en) © ISO 2024
ISO 23402‐3:2024(en)
© ISO 2024
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 23402‐3:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 3
4.1 Applicable classifications .3
4.2 Classification according to the degree of integration and location .3
4.2.1 General .3
4.2.2 Type A: Fully integrated .3
4.2.3 Type B: Remote .3
4.2.4 Type C: Standalone .3
4.3 Classification according to air flow rate .3
5 Requirements . 4
5.1 General .4
5.2 Protection against electric shock .4
5.3 Safety requirements .4
5.4 Electromagnetic compatibility.4
5.5 Utility requirements .5
5.5.1 Compressed air supply .5
5.5.2 Suction waste container .5
5.6 Operational requirements .5
5.6.1 General .5
5.6.2 Cleaning .5
5.7 Characterization of portable suction equipment flow rate performance.5
5.8 Maximum suction pressure .5
5.9 Amalgam separator .6
5.10 Bacterial filter .6
6 Sampling . 6
7 Measurement and test methods . 6
7.1 General .6
7.1.1 General provisions for tests .6
7.1.2 Reference conditions (air flow rates) .6
7.1.3 Atmospheric conditions .6
7.1.4 Other conditions .7
7.2 Performance tests .7
7.2.1 Measurement of flow rate performance .7
7.2.2 Measurement of maximum suction pressure of portable suction equipment
types A and C .7
7.2.3 Measurement of maximum suction pressure of type B portable suction
equipment .7
7.2.4 Measures to prevent excessive suction pressure .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.