EN ISO 7494-2:2022

Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2022)

This document specifies requirements and test methods for stationary dental units concerning
a) the properties of stationary dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the stationary dental unit,
c) the quality for incoming water and air,
d) the performance of stationary dental unit suction system, and
e) the air, water, suction and wastewater properties of stationary dental unit connections to the interfaces to dental handpieces.
This document also specifies requirements for instructions for use and technical description.
This document does not specify requirements or test methods for the effectiveness of stationary dental unit waterline biofilm control.
NOTE       Test methods for the effectiveness of stationary dental unit waterline biofilm control are specified in ISO 16954.
This document is only applicable to stationary dental units that are not used for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this document.

Zahnheilkunde - Fest installierte dentale Behandlungseinheiten und dentale Patientenliegen - Teil 2: Luft-, Wasser-, Absaug- und Abwassersysteme (ISO 7494-2:2022)

Dieses Dokument legt Anforderungen und Prüfverfahren für fest installierte dentale Behandlungseinheiten fest für
a)   die Eigenschaften der Anschlüsse der fest installierten dentalen Behandlungseinheiten zur Druckluftversorgung, Wasserversorgung, Absaugung und zu den Abwasserrohrleitungen,
b)   die Materialien, die Gestaltung und die Bauweise der Druckluft- und Wasserversorgung innerhalb der fest installierten dentalen Behandlungseinheit,
c)   die Qualität des einströmenden Wassers und der einströmenden Luft,
d)   die Leistungsfähigkeit des Absaugsystems in der fest installierten dentalen Behandlungseinheit, und
e)   die auf Luft, Wasser, Absaugung und Abwasser bezogenen Eigenschaften der Anschlüsse der fest installierten dentalen Behandlungseinheit an den Schnittstellen zu dentalen Handstücken.
Dieses Dokument legt auch Anforderungen an die Gebrauchsanweisung und an die technische Beschreibung fest.
Dieses Dokument legt keine Anforderungen oder Prüfverfahren für die Wirksamkeit der Kontrolle von Biofilm in der Wasserleitung einer fest installierten dentalen Behandlungseinheit fest.
ANMERKUNG   Prüfverfahren für die Wirksamkeit der Kontrolle von Biofilm in der Wasserleitung einer fest installierten dentalen Behandlungseinheit sind in ISO 16954 festgelegt.
Dieses Dokument ist nur für fest installierte dentale Behandlungseinheiten anwendbar, die nicht für kieferchirurgische Behandlungen eingesetzt werden, die eine sterile Luft- und Wasserversorgung erfordern. Amalgamabscheider sind in diesem Dokument nicht enthalten.

Médecine bucco-dentaire - Units dentaires fixes et fauteuils dentaires patient - Partie 2: Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées (ISO 7494-2:2022)

Le présent document spécifie les exigences et les méthodes d'essai destinées aux units dentaires fixes concernant:
a) les propriétés des branchements des units dentaires fixes aux conduites d'alimentation en air comprimé, d'alimentation en eau, d'aspiration et aux canalisations d'évacuation des eaux usées;
b) les matériaux, la conception et la construction du système d'alimentation en air comprimé et en eau de l'unit dentaire fixe;
c) la qualité de l'eau et de l'air d'entrée;
d) la performance du système d'aspiration de l'unit dentaire fixe; et
e) les propriétés de l'air, de l'eau, de l'aspiration et des eaux usées des branchements des units dentaires fixes aux interfaces des pièces à main dentaires.
Le présent document spécifie également les exigences relatives aux consignes d'utilisation et à la description technique.
Le présent document ne spécifie pas d'exigences ou de méthodes d'essai concernant l'efficacité du contrôle du biofilm dans les conduites d'eau de l'unit dentaire fixe.
NOTE       Les méthodes d'essai relatives à l'efficacité du contrôle du biofilm dans les conduites d'eau de l'unit dentaire fixe sont spécifiées dans l'ISO 16954.
Le présent document s'applique uniquement aux units dentaires fixes qui ne sont pas utilisées pour des traitements de chirurgie buccale nécessitant un approvisionnement en air et en eau stériles. Les séparateurs d'amalgames ne sont pas inclus dans le présent document.

Zobozdravstvo - Stacionarne dentalne enote in stoli za paciente - 2. del: Sistemi za dovod zraka in vode, za sukcijo (aspiracijo) in odvod odpadne vode (ISO 7494-2:2022)

Ta dokument določa zahteve in preskusne metode za stacionarne dentalne enote v zvezi z naslednjim: a) lastnosti priključkov stacionarne dentalne enote za dovod stisnjenega zraka in vode, sukcija (aspiracija) ter odvod odpadne vode; b) materiali, zasnova in izdelava sistema za dovod stisnjenega zraka in vode znotraj stacionarne dentalne enote; c) kakovost vode in zraka, ki se dovajata; d) učinkovitost sistema za sukcijo (aspiracijo) stacionarne dentalne enote; e) lastnosti priključkov stacionarne dentalne enote za dovod zraka in vode, sukcija (aspiracija) ter odvod odpadne vode za medsebojno delovanje z dentalnimi pripomočki. Ta dokument določa tudi zahteve za navodila za uporabo in tehnični opis. Ta dokument ne določa zahtev oziroma preskusnih metod za učinkovitost nadzora biofilma na vodni gladini znotraj stacionarne dentalne enote. OPOMBA: Preskusne metode za učinkovitost nadzora biofilma na vodni gladini znotraj stacionarne dentalne enote so določene v standardu ISO 16954. Ta dokument se uporablja samo za stacionarne dentalne enote, ki se ne uporabljajo pri operacijah ustne votline, pri katerih se zahteva dovod sterilnega zraka in vode. Ločevalniki amalgama niso vključeni v ta dokument.

General Information

• Status: Published
• Publication Date: 18-Oct-2022
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Oct-2022
• Completion Date: 19-Oct-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Ref Project: SIST EN ISO 7494-2:2023 - Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2022)

Relations

• Replaces: EN ISO 7494-2:2015 - Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
• Effective Date: 26-Oct-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2023
Nadomešča:
SIST EN ISO 7494-2:2015
Zobozdravstvo - Stacionarne dentalne enote in stoli za paciente - 2. del: Sistemi za
dovod zraka in vode, za sukcijo (aspiracijo) in odvod odpadne vode (ISO 7494-
2:2022)
Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction
and wastewater systems (ISO 7494-2:2022)
Zahnheilkunde - Fest installierte dentale Behandlungseinheiten - Teil 2: Luft-, Wasser-,
Absaug- und Abwassersysteme (ISO 7494-2:2022)
Médecine bucco-dentaire - Units dentaires fixes et fauteuils dentaires patient - Partie 2:
Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées
(ISO 7494-2:2022)
Ta slovenski standard je istoveten z: EN ISO 7494-2:2022
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 7494-2
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 7494-2:2015
English Version
Dentistry - Stationary dental units and dental patient
chairs - Part 2: Air, water, suction and wastewater systems
(ISO 7494-2:2022)
Médecine bucco-dentaire - Units dentaires fixes et Zahnheilkunde - Fest installierte dentale
fauteuils dentaires patient - Partie 2: Systèmes Behandlungseinheiten - Teil 2: Luft-, Wasser-, Absaug-
d'alimentation en air et en eau, d'aspiration et und Abwassersysteme (ISO 7494-2:2022)
d'évacuation des eaux usées (ISO 7494-2:2022)
This European Standard was approved by CEN on 4 June 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7494-2:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7494-2:2022) 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 April 2023, and conflicting national standards shall be
withdrawn at the latest by April 2023.
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 7494-2:2015.
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 7494-2:2022 has been approved by CEN as EN ISO 7494-2:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 7494-2
Third edition
2022-07
Dentistry — Stationary dental units
and dental patient chairs —
Part 2:
Air, water, suction and wastewater
systems
Médecine bucco-dentaire — Units dentaires fixes et fauteuils
dentaires patient —
Partie 2: Systèmes d'alimentation en air et en eau, d'aspiration et
d'évacuation des eaux usées
Reference number
ISO 7494-2:2022(E)
ISO 7494-2:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 7494-2:2022(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 4
4.1 Classification of suction systems . 4
4.2 Classification of suction air flow rate . 4
5 Requirements . 4
5.1 Connections from the stationary dental unit to dental handpieces . 4
5.1.1 General . 4
5.1.2 Powered scaler . 4
5.1.3 Multifunction handpiece . 5
5.1.4 Handpiece and motor . 5
5.1.5 Powder jet handpiece . 5
5.1.6 Simultaneous use of more than one dental handpiece . 6
5.2 Supply connections to the stationary dental unit . 6
5.3 Water and wastewater systems . 8
5.3.1 General . 8
5.3.2 Incoming water . 8
5.3.3 Materials used for construction of procedural water systems within the
stationary dental unit . 8
5.3.4 Backflow prevention device for stationary dental units connected to the
external drinking water supply . 9
5.3.5 Cuspidors . . 9
5.3.6 Water venturi . 9
5.3.7 Particle filter . 9
5.3.8 Bacterial filter . 9
5.3.9 Bottled water system supplying procedural water or solution . 9
5.3.10 Retraction . 9
5.3.11 Treatment method for biofilm . 10
5.3.12 Water sampling connection point . 10
5.3.13 Wastewater drain connection . 11
5.4 Air system . 11
5.4.1 General . 11
5.4.2 Incoming dental air . 11
5.4.3 Particle filters . 11
5.4.4 Bacterial filters . 11
5.5 Stationary dental unit suction systems .12
5.5.1 General .12
5.5.2 Maximum suction pressure .12
5.5.3 Suction pressure head loss .12
5.5.4 Configuration of cannula connectors and cannula .12
5.5.5 Operating hoses with cannula connectors . 14
5.5.6 Solids filter . 14
5.5.7 Air separator . 14
5.5.8 Stationary dental unit suction source connection point . 14
5.6 Test report .
...