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)

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 - Teil 2: Luft-, Wasser-, Absaug- und Abwassersysteme (ISO 7494-2:2022)

Dieses Dokument legt Anforderungen und Prüfverfahren für stationäre dentale Behandlungseinheiten fest für
a) die Eigenschaften der Anschlüsse der stationären dentalen Behandlungseinheiten zur Druckluftversorgung, Wasserversorgung, Absaugung und zu den Abwasserrohrleitungen,
b) die Materialien, Gestaltung und Bauweise der Druckluft- und Wasserversorgung innerhalb der stationären dentalen Behandlungseinheit,
c) die Qualität des einströmenden Wassers und der einströmenden Luft, und
d) die Leistungsfähigkeit des Absaugsystems in der stationären dentalen Behandlungseinheit, und
e) die Luft-, Wasser-, Absaugungs- und Abwassereigenschaften von stationären dentalen Behandlungseinheiten 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 stationären dentalen Behandlungseinheit fest.
ANMERKUNG Prüfverfahren für die Wirksamkeit der Kontrolle von Biofilm in der Wasserleitung einer stationären dentalen Behandlungseinheit sind in ISO 16954 festgelegt.
Dieses Dokument beschränkt sich auf stationäre dentale Behandlungseinheiten, 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
• Public Enquiry End Date: 19-Apr-2021
• Publication Date: 14-Dec-2022
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Dec-2022
• Due Date: 05-Feb-2023
• Completion Date: 15-Dec-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: 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)

Relations

• Replaces: SIST EN ISO 7494-2:2015 - Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
• Effective Date: 01-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7494-2:2023
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
SIST EN ISO 7494-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 7494-2:2023

---------------------- Page: 2 ----------------------
SIST EN ISO 7494-2:2023


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.

---------------------- Page: 3 ----------------------
SIST EN ISO 7494-2:2023
EN ISO 7494-2:2022 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 7494-2:2023
EN ISO 7494-2:2022 (E)
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.

3

---------------------- Page: 5 ----------------------
SIST EN ISO 7494-2:2023

---------------------- Page: 6 ----------------------
SIST EN ISO 7494-2:2023
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 2022

---------------------- Page: 7 ----------------------
SIST EN ISO 7494-2:2023
ISO 7494-2:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 2022 – All rights reserved

---------------------- Page: 8 ----------------------
SIST EN ISO 7494-2:2023
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 . 14
6 Sampling .14
7 Measurement and test methods .14
7.1 Visual inspection . 14
7.1.1 Visual inspection of device . 14
7.1.2 Visual inspection of documentation or test reports . . 14
iii
© ISO 2022 – All rights reserved

---------------------- Page: 9 ----------------------
SIST EN ISO 7494-2:2023
ISO 7494-2:2022(E)
7.2 Dental handpiece connection test . 15
7.2.1 Apparatus . 15
7.2.2 Procedure .15
7.3 Systems directly connected to external drinking water supply test . 17
7.4 Cuspidor test . 17
7.5 Particle filter test . 17
7.6 Retraction test . 17
7.7 Stationary dental unit suction systems test. 18
7.7.1 General . 18
7.7.2 Static suction pressure test . 18
7.7.3 Suction pressure head loss test . 19
7.8 Treatment method for the prevention or inhibition of biofilm formation .20
7.9 Treatment method for biofilm removal . 20
8 Instructions for use . .20
9 Technical description .21
Annex A (informative) Example of schematic diagram of components and connections in a
stationary dental unit .23
Annex B (informative) Dental handpiece connection test jig .25
Annex C (informative) Test sequence .26
Bibliography .31
iv
  © ISO 2022 – All rights reserved

---------------------- Page: 10 ----------------------
SIST EN ISO 7494-2:2023
ISO 7494-2:2022(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 106, Dentistry, Subcommittee SC 6,
Dental equipment, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 7494-2:2015), which has been technically
revised.
The main changes are as follows:
— the requirements in this document have been limited to stationary dental units;
— the requirements for connections from the stationary dental unit to dental handpieces have been
added in 5.1;
— measurement procedures for air flow and water flow have been added in 7.2.2;
— requirements for treatment methods for dental unit waterline biofilm have been added in 5.3.11;
— the requirement for noise level for dental suction systems has been removed since that main
contribution to noise comes from the cannula, which is outside of the scope of this document.
A list of all parts in the ISO 7494 series can be found on the ISO website.
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.
v
© ISO 2022 – All rights reserved

---------------------- Page: 11 ----------------------
SIST EN ISO 7494-2:2023

---------------------- Page: 12 ----------------------
SIST EN ISO 7494-2:2023
INTERNATIONAL STANDARD ISO 7494-2:2022(E)
Dentistry — Stationary dental units and dental patient
chairs —
Part 2:
Air, water, suction and wastewater systems
1 Scope
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.
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 1942, Dentistry — Vocabulary
ISO 7494-1, Dentistry — Stationary dental units and dental patient chairs — Part 1: General requirements
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 10637, Dentistry — Central suction source equipment
ISO 14457, Dentistry — Handpieces and motors
ISO 18397, Dentistry — Powered scaler
ISO 20608, Dentistry — Powder jet handpieces and powders
ISO 22569, Dentistry — Multifunction handpieces
1
© ISO 2022 – All rights reserved

---------------------- Page: 13 ----------------------
SIST EN ISO 7494-2:2023
ISO 7494-2:2022(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 7494-1, ISO 10637,
ISO 14457, ISO 18397, ISO 20608, ISO 22569 and the following 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
bacterial filter
filter designed to restrict the passage of bacteria and reduce bacteria in the procedural water (3.15) or
in the compressed air
3.2
backflow
flow of water and/or another medium back into the external drinking water supply
3.3
backflow prevention device
safety device to hinder backflow (3.2)
3.4
bottled water system
water system of the stationary dental unit in which procedural water (3.15) is supplied by an included
reservoir which is not connected to an external drinking water supply system and is manually filled
with procedural water (3.15)
3.5
dental air
compressed air supplied through the stationary dental unit for powering, controlling, and/or assisting
various dental handpieces and equipment, as well as for assisting practitioners with procedures in the
oral cavity, but not for procedures requiring medical air or sterile air, such as endoscopy, oral surgery,
analgesia, and life support
3.6
incoming dental air connection point
port on the stationary dental unit for connection to an external compressed air supply
3.7
stationary dental unit suction system
components located between the facility suction pipeline connection point and the cannula connector
that are part of the stationary dental unit which enable an air flow to be induced which is designed to
remove liquids, solids, and airborne liquid or solid particulates from the mouth of the dental patient
during dental treatment
Note 1 to entry: Suction source equipment may be included in either stationary dental unit or dental patient
chair, or both, in which case no facility suction pipeline connection point exists.
3.8
stationary dental unit suction source connection point
port on the stationary dental unit for connection to a supply of dental suction
3.9
exhaust air
dental air discharged from an air motor or turbine after being used to power the air motor or turbine
3.10
filter
apparatus that restricts targeted constituents from passing through it
2
  © ISO 2022 – All rights reserved

---------------------- Page: 14 ----------------------
SIST EN ISO 7494-2:2023
ISO 7494-2:2022(E)
3.11
incoming solution
solution of substances specified by the manufacturer, and introduced in combination with, or in place
of, the incoming water (3.12) in order to improve or maintain the quality of the procedural water (3.15)
or for other reasons
EXAMPLE Coolant for cutting burs or medicament for oral cavity.
3.12
incoming water
water supplied to the stationary dental unit for procedural use or non-procedural use
3.13
incoming water connection point
port on the stationary dental unit for connection to an external drinking water supply
3.14
non-procedural water
water supplied by the stationary dental unit for purposes other than use in the oral cavity
EXAMPLE Cuspidor bowl rinse water, water venturi (3.20), supply water.
3.15
procedural water
water supplied by the stationary dental unit for use in the oral cavity
EXAMPLE Handpiece coolant water, multifunction handpiece (syringe) water, scaler coolant water, cup fill
water.
3.16
retraction
re-entry of water, air, and/or other medium into the stationary dental unit or the dental handpiece due
to flow reversal
EXAMPLE Momentary dynamic pressure variations during turning off the handpiece.
3.17
spill-over level
highest possible level of water or solution in a device above which the fluid will flow over the edge
3.18
wastewater
solution that is discharged into the drainage system by way of the cuspidor drain, saliva ejector, air
separator, amalgam separator, or other component or system of the stationary dental unit
3.19
water disinfection system
system designed to reduce the microbiological contamination in a stationary dental unit procedural
water (3.15)
3.20
water venturi
device using waterflow to produce a suction
3.21
wastewater connection point
port for the connection through which wastewater (3.18) flows and is discharged into the drains
3
© ISO 2022 – All rights reserved

---------------------- Page: 15 ----------------------
SIST EN ISO 7494-2:2023
ISO 7494-2:2022(E)
4 Classification
4.1 Classification of suction systems
According to ISO 10637, suction systems
...

SLOVENSKI STANDARD
oSIST prEN ISO 7494-2:2021
01-april-2021
Zobozdravstvo - Stacionarne dentalne enote - 2. del: Sistemi za dovod zraka in
vode, za sukcijo (aspiracijo) in odvod odpadne vode (ISO/DIS 7494-2:2021)
Dentistry - Stationary dental units - Part 2: Air, water, suction and wastewater systems
(ISO/DIS 7494-2:2021)
Zahnheilkunde - Fest installierte dentale Behandlungseinheiten - Teil 2: Luft-, Wasser-,
Absaug- und Abwassersysteme (ISO/DIS 7494-2:2021)
Médecine bucco-dentaire - Units dentaires fixes - Partie 2: Systèmes d’alimentation en
air et en eau, d’aspiration et d’évacuation des eaux usées (ISO/DIS 7494-2:2021)
Ta slovenski standard je istoveten z: prEN ISO 7494-2
ICS:
11.060.20 Zobotehnična oprema Dental equipment
oSIST prEN ISO 7494-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 7494-2:2021

---------------------- Page: 2 ----------------------
oSIST prEN ISO 7494-2:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7494-2
ISO/TC 106/SC 6 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-02-11 2021-05-06
Dentistry — Stationary dental units —
Part 2:
Air, water, suction and wastewater systems
Partie 2: Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7494-2:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021

---------------------- Page: 3 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
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 Powered scaler . 4
5.1.2 Multifunction handpiece . 5
5.1.3 Handpiece and motor . 5
5.1.4 Powder jet handpiece . 5
5.1.5 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 . 8
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 .12
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 .13
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 .14
6 Sampling .14
7 Measurement and test methods .15
7.1 Visual inspection .15
7.1.1 Visual inspection of device .15
7.1.2 Visual inspection of documentation or test reports .15
© ISO 2021 – All rights reserved iii

---------------------- Page: 5 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

7.2 Dental handpiece connection test .15
7.2.1 Apparatus .15
7.2.2 Procedure .17
7.3 Systems directly connected to external drinking water supply test .18
7.4 Cuspidor test .18
7.5 Particle filter test .19
7.6 Retraction test .19
7.7 Stationary dental unit suction systems test .19
7.7.1 Static suction pressure test .20
7.7.2 Suction pressure head loss test .20
7.8 Treatment method for biofilm prevention or inhibition .21
7.9 Treatment method for biofilm removal .22
8 Instructions for use .22
9 Technical description .23
Annex A (informative) Schematic diagram of components and connections in a stationary
dental unit (example) .24
Annex B (informative) Test sequence .27
Bibliography .33
iv © ISO 2021 – All rights reserved

---------------------- Page: 6 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(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 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This third edition cancels and replaces the second edition (ISO 7494-2:2015), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— clarification that requirements in this document are limited to stationary dental units;
— requirements for connections from the stationary dental unit to dental handpieces were added as
subclause 5.1;
— measurement procedures for air flow and water flow were added in 7.2.2;
A list of all parts in the ISO 7494 series can be found on the ISO website.
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.
© ISO 2021 – All rights reserved v

---------------------- Page: 7 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

Introduction
This document specifies requirements and test methods pertaining to components of stationary dental
units which convey air, water, suction, and wastewater. The requirements in this document focus on
certain technical aspects to be appropriate for international standardization. The working group
acknowledges that requirements for microbiological aspects of the fluids transported in the stationary
dental units are also worthy of standardization and is working to develop requirements pertaining to
the prevention, inhibition, and removal of stationary dental unit waterline biofilm. Additional projects
to develop microbiological requirements for air, water, and/or suction may follow.
vi © ISO 2021 – All rights reserved

---------------------- Page: 8 ----------------------
oSIST prEN ISO 7494-2:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 7494-2:2021(E)
Dentistry — Stationary dental units —
Part 2:
Air, water, suction and wastewater systems
1 Scope
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, and
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 limited 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.
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 1942, Dentistry — Vocabulary
ISO 7494-1, Dentistry — Stationary dental units and dental patient chairs — Part 1: General requirements
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 10637, Dentistry — Central suction source equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 7494-1, ISO 10637,
ISO 14457, ISO 18397, ISO 20608, ISO 22569 and the following apply.
© ISO 2021 – All rights reserved 1

---------------------- Page: 9 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
bacterial filter
filter designed to restrict the passage of bacteria and reduce bacteria in the procedural water (3.15) or
in the compressed air
3.2
backflow
flow of water and/or another medium back into the external drinking water supply
3.3
backflow prevention device
safety device to prevent backflow (3.2)
3.4
bottled water system
water system of the stationary dental unit in which procedural water (3.15) is supplied by an included
reservoir which is not connected to an external drinking water supply system and is manually filled
with procedural water (3.15)
3.5
dental air
compressed air supplied through the stationary dental unit for powering, controlling, and/or assisting
various dental handpieces and equipment, as well as for assisting practitioners with procedures in the
oral cavity, but not for procedures requiring medical air or sterile air, such as endoscopy, oral surgery,
analgesia, and life support
3.6
incoming dental air connection point
any port on the stationary dental unit for connection to an external compressed air supply
3.7
stationary dental unit suction system
components located between the facility suction pipeline connection point and the cannula connector
that are part of the stationary dental unit which enable an air flow to be induced which is designed to
remove liquids, solids, and airborne liquid or solid particulates from the mouth of the dental patient
during dental treatment
Note 1 to entry: Suction source equipment may be included in stationary dental unit and/or dental patient chair,
in which case no facility suction pipeline connection point exists.
3.8
stationary dental unit suction source connection point
any port on the stationary dental unit for connection to a supply of dental suction
3.9
exhaust air
dental air discharged from an air motor or turbine after being used to power the air motor or turbine
3.10
filter
apparatus which restricts targeted constituents from passing through it
2 © ISO 2021 – All rights reserved

---------------------- Page: 10 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

3.11
incoming solution
solution of substances specified by the manufacturer, and introduced in combination with, or in place
of, the incoming water (3.12) in order to improve or maintain the quality of the procedural water (3.15)
or for other reasons, such as coolant for cutting burs or medicament for oral cavity
3.12
incoming water
water supplied to the stationary dental unit for procedural use or non-procedural use
3.13
incoming water connection point
any port on the stationary dental unit for connection to an external drinking water supply
3.14
non-procedural water
water supplied by the stationary dental unit for purposes other than use in the oral cavity
EXAMPLE Cuspidor bowl rinse water, water venturi (3.20), supply water
3.15
procedural water
water supplied by the stationary dental unit for use in the oral cavity
EXAMPLE Handpiece coolant water, multifunction handpiece (syringe) water, scaler coolant water, cup
fill water
3.16
retraction
re-entry of water, air, and/or other medium into the stationary dental unit or the dental handpiece due
to flow reversal
EXAMPLE Momentary dynamic pressure variations during turning off the handpiece.
3.17
spill-over level
highest possible level of water or solution in a device above which the fluid will flow over the edge
3.18
wastewater
solution that is discharged into the drainage system by way of the cuspidor drain, saliva ejector, air
separator, amalgam separator, or other component or system of the stationary dental unit
3.19
water disinfection system
system designed to reduce the microbiological contamination in a stationary dental unit procedural
water (3.15)
3.20
water venturi
device using waterflow to produce a suction
3.21
wastewater connection point
port for the connection through which wastewater (3.18) flows and is discharged into the drains
© ISO 2021 – All rights reserved 3

---------------------- Page: 11 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

4 Classification
4.1 Classification of suction systems
According to ISO 10637, suction systems are classified to the type of suction as follows:
a) Dry-suction system;
b) Semi-dry-suction system;
c) Wet-suction system.
4.2 Classification of suction air flow rate
According to ISO 10637, suction systems are classified to the type of air flow rate as follows:
Type 1: Suction system intended to supply a minimum air flow rate of 250 NL/min at one suction
cannula connector on the stationary dental unit.
NOTE Often referred to as “High-volume suction systems”.
Type 2: Suction system intended to supply a minimum air flow rate of 170 NL/min at one suction
cannula connector on the stationary dental unit.
Type 3: Suction system intended to supply a minimum air flow rate of 90 NL/min at one suction cannula
connector on the stationary dental unit.
NOTE Often referred to as “Medium-volume suction systems”.
5 Requirements
5.1 Connections from the stationary dental unit to dental handpieces
Technical description shall include the configuration of the air and water connections to the applicable
dental handpieces.
NOTE This information helps dentists to select dental handpieces that perform clinically as expected.
5.1.1 Powered scaler
The flowrate and pressure for air and water supplied by the stationary dental unit at the connection to
the powered scaler shall meet the specifications of the manufacturer.
NOTE For reference, air and water flowrates for powered scalers according to ISO 18397 and typical values:
a) Air-powered and electrical powered scalers:
A water flowrate of at least 20 ml/min at a pressure specified by the manufacturer is specified in ISO 18397.
An adjustable flow rate up to 25 ml/min at a pressure of 250 kPa is typical.
b) Air powered scalers:
An air flowrate of up to 66 Nl/min at a pressure of (300 ± 100) kPa [(3,0 ± 1, 0) bar] is specified in ISO 18397.
An air flow rate of 30 Nl/min is typical.
Test in accordance with 7.2.
The manufacturer's specification for air and water flowrate and pressure at the connection to the
powered scaler shall be provided in the technical description and in the instructions for use.
4 © ISO 2021 – All rights reserved

---------------------- Page: 12 ----------------------
oSIST prEN ISO 7494-2:2021
ISO/DIS 7494-2:2021(E)

5.1.2 Multifunction handpiece
The flowrate and pressure for air and water supplied by the stationary dental unit at the connection to
the multifunction handpiece shall meet the specifications of the manufacturer.
NOTE For reference, air and water flowrates for multifunction handpiece according to ISO 22569 and
typical values:
a) An air flowrate of at least 10 Nl/min at a pressure specified by the manufacturer is specified in ISO 22569.
An air flowrate of 10 Nl/min at a pressure of 300 kPa [3,0 bar] is typical.
b) A water flowrate of at least 50 ml/min at a pressure specified by the manufacturer is specified in ISO 22569.
A water flow rate of 50 ml/min at a pressure of 140 kPa [1,4 bar] is typical.
Test in accordance with 7.2.
The manufacturer's specification for air and water flowrate and pressure at the connection to the
multifunction handpiece shall be provided in the technical description and in the instructions for use.
5.1.3 Handpiece and motor
The flowrate and pressure for air and water supplied by the stationary dental unit at the connection to
the handpiece or motor shall meet the specifications of the manufacturer.
NOTE For reference, air and water flowrates for handpiece and motor according to ISO 14457 and typical
values:
a) For high-speed air turbine handpieces, air motors, handpieces with integrated air motor and prophy
handpieces with integrated air motor a maximum air flow rate of 80 Nl/min at a pressure of (300 ± 100) kPa
[(3,0 ±
...