SIST EN ISO 7494-2:2023
(Main)Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (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 - 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
Relations
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: +41 22 749 01 11
Email: copyright@iso.org
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 . 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 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 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
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
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
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
ISO 7494-2:2022(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 1 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 2 Often referred to as “medium-volume suction systems”.
5 Requirements
5.1 Connections from the stationary dental unit to dental handpieces
5.1.1 General
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.
5.1.2 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 Air and water flowrate specifications for powered scalers according to ISO 18397 and typical values
are as follows:
a) Air-powered and electrical powered scalers: A minimum water flowrate is specified in ISO 18397. An
adjustable flow rate up to 25 ml/min at a pressure specified by the manufacturer is typical.
b) Air-powered scalers: An air flowrate of up to 66 Nl/min at a pressure of (300 ± 100) kPa is specified in
ISO 18397. An air flow rate of 30 Nl/min at a pressure of 300 kPa 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.
ISO 7494-2:2022(E)
5.1.3 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 Air and water flowrate specifications for multifunction handpiece according to ISO 22569 and typical
values are as follows:
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 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 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.
5.1.4 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 Air and water flowrate specifications for handpiece and motor according to ISO 14457 and typical
values are as follows:
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
is specified in ISO 14457. An air flow rate of 55 Nl/min at a pressure of 300 kPa is typical for a wide range of
high speed air turbine handpieces.
b) For electrical motors equipped with an air-cooling system a maximum air supply with 40 Nl/min at a
pressure range of 250 kPa to 500 kPa is specified in ISO 14457. An air flow rate of 20 Nl/min at a pressure of
250 kPa to 500 kPa is typical.
c) A spray air flowrate of at least 1,5 Nl/min at a pressure of 250 kPa is specified in ISO 14457 and is typical.
d) A water flow rate of at least 50 ml/min at a pressure of 250 kPa is specified in ISO 14457 and is typical.
Test in accordance with 7.2.
The manufacturer's specification for air and water flowrate and pressure at the connection to the
handpiece or motor shall be provided in the technical description and in the instructions for use.
5.1.5 Powder jet handpiece
The flowrate and pressure for air and water supplied by the stationary dental unit at the connection to
the powder jet handpiece shall meet the specifications of the manufacturer.
NOTE Air and water flowrate specifications for powder jet handpieces according to ISO 20608 and typical
values are as follows:
a) A maximum drive air flowrate of 40 Nl/min at 250 kPa is specified in ISO 20608.
b) A water flowrate of at least 20 ml/min at 150 kPa is specified in ISO 20608 and is typical.
Test in accordance with 7.2.
The manufacturer's specification for air and water flowrate and pressure at the connection to the
powder jet handpiece shall be provided in the technical description and in the instructions for use.
ISO 7494-2:2022(E)
5.1.6 Simultaneous use of more than one dental handpiece
Unless the simultaneous use of multiple dental handpieces is excluded by design or contraindicated
in the instructions for use, the requirements for minimum water flow rate and minimum air flow rate
specified in 5.1.1 to 5.1.5 shall be met when the multifunction handpiece is operated simultaneously
with each of the other dental handpieces or motors.
Test in accordance with 7.2.
5.2 Supply connections to the stationary dental unit
Technical description shall include the configuration of the supply connections for the stationary
dental unit. The specified configuration of the supply connections shall be within a maximum area of
180 mm × 220 mm.
Technical description shall include detailed information of the position and the dimensions of supply
connections (see Figure 1) for the stationary dental unit in the dental practice.
ISO 7494-2:2022(E)
Dimensions in millimetres
Key
1 wastewater connection point
2 incoming water connection point
3 stationary dental unit suction source connection point
4 connection area for electricity and telecommunication
5 connection area for dental air
Figure 1 — Example of configuration of connection points and adjacent supply areas
In the dental practice, often a core hole in the floor with a diameter of 160 mm is used. Therefore, it is
recommended to place the supply connections within this diameter.
An example of the configuration and the connection points is given in Figure 1.
Dimensions for the connections for electricity and compressed air areas (see Figure 1, keys 4 and 5) are
given as maximum values.
Dimensions for plumbing holes (see Figure 1, key 1, 2, and 3) are given as minimum values. The
diameters specify the free space required for tubes and hoses.
The holes without dimensions can be positioned anywhere inside the connection area.
ISO 7494-2:2022(E)
Gas tubing, if required, shall not be located inside the areas specified in Figure 1.
The location of other utility connections which are not indicated shall be specified by the manufacturer.
Test in accordance with 7.1.
5.3 Water and wastewater systems
5.3.1 General
A schematic diagram of possible water and wastewater systems is given as example in Figure A.1.
5.3.2 Incoming water
If the stationary dental unit is intended to be directly connected to an external drinking water supply,
the water supply shall be adjustable to provide the range of incoming water pressure specified by the
manufacturer.
Instructions for use and technical description shall specify the requirements for the incoming water to
be supplied to the stationary dental unit, including the following parameters:
a) water pressure limit;
b) water flow rate limit;
c) water hardness limit;
d) pH limits;
e) maximum particle size;
f) requirements for microbiological quality.
NOTE 1 Regional regulations can apply for drinking water.
NOTE 2 The following ranges are typical ranges:
a) water pressure limit (200 kPa to 600 kPa);
b) water flow rate limit (greater than 5 l/min);
c) water hardness limit [less than 2,14 mmol/l;
d) pH limits (6,5 to 8,5);
e) maximum particle size (<100 µm).
Test in accordance with 7.1.
5.3.3 Materials used for construction of procedural water systems within the stationary dental
unit
The materials used within the water path within the stationary dental unit shall be documented.
A risk assessment with respect to user, patient and third party shall be applied.
NOTE Treatments specified by the manufacturer of the stationary dental unit, such as the use of chemical
agents in the procedural water system, could interact with the materials used in the procedural water system to
affect the procedural water, which comes in contact with the patient’s mucous membrane and wounds.
Test in accordance with 7.1.
ISO 7494-2:2022(E)
5.3.4 Backflow prevention device for stationary dental units connected to the external
drinking water supply
If the stationary dental unit is directly connected to the external drinking water supply, the technical
description shall specify whether the stationary dental unit contains a backflow prevention device.
If the stationary dental unit contains a backflow prevention device, the backflow prevention device
shall be at the incoming water connection point. If the backflow prevention device is an air gap, the air
gap shall not be less than 20 mm.
NOTE Additional means of protection can be required by national or regional drinking water regulations.
If the stationary dental unit does not contain a backflow prevention device, the technical description
shall include a reminder that the stationary dental unit must be installed in conformance with local
backflow prevention regulations.
Test in accordance with 7.3.
5.3.5 Cuspidors
The point where the cuspidor rinse water is dispensed shall be at least 20 mm above the spill-over level
of the cuspidor.
Test in accordance with 7.4.
5.3.6 Water venturi
Water venturi for suction of saliva and water shall only be used if an additional backflow prevention
device is installed at the connection point of the water venturi device.
Test in accordance with 7.1.
5.3.7 Particle filter
A stationary dental unit directly connected to an external drinking water supply shall have at least
one particle filter with an effective mesh size not greater than 100 μm installed at the incoming water
connection point.
Test in accordance with 7.5.
5.3.8 Bacterial filter
If the stationary dental unit water supply is equipped with a filter intended to restrict the passage of
bacteria, the bacterial filter shall be rated to restrict the passage of contaminants larger than 0,22 μm.
The stationary dental unit manufacturer shall provide maintenance instructions and schedule for the
bacterial filter.
Test in accordance with 7.1.
5.3.9 Bottled water system supplying procedural water or solution
These systems shall either be completely separated from the external drinking water supply system
or shall have a backflow prevention device at the connection point with the external drinking water
supply system.
Test in accordance with 7.1.
5.3.10 Retraction
The volume of the retraction of procedural water or solution shall not exceed 40 mm (= 0,04 ml).
ISO 7494-2:2022(E)
Test in accordance with 7.6.
5.3.11 Treatment method for biofilm
5.3.11.1 General
The manufacturer shall specify a treatment method either for preventing or inhibiting stationary
dental unit waterline biofilm formation (see 5.3.11.2) or for removing stationary dental unit waterline
biofilm (see 5.3.11.3), or both in the instructions for use or technical description.
If the treatment method includes a system for manually or automatically introducing a chemical agent
to the stationary dental unit waterlines, the system shall either be completely separated from the
external drinking water supply system or shall have a backflow prevention device at the connection
point with the external drinking water supply system.
The manufacturer shall specify the required supplies (e.g. chemical treatment), instructions for use,
maintenance procedures and maintenance frequency associated with the treatment method(s).
5.3.11.2 Treatment method for biofilm prevention or inhibition
The manufacturer shall specify one or more treatment method(s) for preventing or inhibiting stationary
dental unit waterline biofilm formation to achieve acceptable microbiological water quality of the
procedural water supplied by the stationary dental unit.
NOTE 1 Acceptable microbiological water quality complies with national or regional requirements or
recommendations for stationary dental unit procedural water.
NOTE 2 Presently no International Standard for microbiological water quality of stationary dental unit
procedural water lines exists.
Test in accordance with 7.8.
5.3.11.3 Treatment method for biofilm removal
The manufacturer shall specify one or more treatment method(s) for removal of stationary dental unit
waterline biofilm to achieve acceptable microbiological water quality of the procedural water supplied
by the stationary dental unit.
NOTE 1 Acceptable microbiological water quality complies with national or regional requirements or
recommendations for stationary dental unit procedural water.
NOTE 2 Presently no International Standard for microbiological water quality of stationary dental unit
procedural water lines exists.
Manufacturers can specify that these methods shall be performed by qualified personnel only.
Test in accordance with 7.9.
5.3.12 Water sampling connection point
For stationary dental units directly connected to the external drinking water supply, the technical
description should include a recommendation to install a sampling point for incoming water at or near
the incoming water connection point.
NOTE See Figure A.1, key 25.
If the instructions for use recommend installing a sampling point, the instructions for use shall give
information about collecting samples of water and the technical description shall provide information
about the installation and collection of water samples.
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