oSIST prEN ISO 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)

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 - Partie 2: Systèmes d’alimentation en air et en eau, d’aspiration et d’évacuation des eaux usées (ISO/DIS 7494-2:2021)

Zobozdravstvo - Stacionarne dentalne enote - 2. del: Sistemi za dovod zraka in vode, za sukcijo (aspiracijo) in odvod odpadne vode (ISO/DIS 7494-2:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Apr-2021
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 22-Feb-2021
• Due Date: 12-Jul-2021
• Completion Date: 12-May-2021
• 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: prEN ISO 7494-2 - Dentistry - Stationary dental units - Part 2: Air, water, suction and wastewater systems (ISO/DIS 7494-2:2021)

RELATIONS

• Revised: SIST EN ISO 7494-2:2015 - Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
• Effective Date: 01-Apr-2021

Standards Content (sample)

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.

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oSIST prEN ISO 7494-2:2021
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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
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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
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Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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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

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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

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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
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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
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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.
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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
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oSIST prEN ISO 7494-2:2021
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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

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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.

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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 ±
...