Dentistry - Dental Units - : Part 2: Water and Air Supply

BRITISH STANDARD BS EN ISO
7494-2:2003
Incorporating
Corrigendum No. 1
Dentistry —
Dental units —
Part 2: Water and air supply
The European Standard EN ISO 7494-2:2003 has the status of a

British Standard
ICS 11.060.20
12&23<,1*:,7+287%6,3(50,66,21(;&(37$63(50,77('%<&23<5,*+7/$:
Copyright British Standards Institution
Provided by IHS under license with BSI
No reproduction or networking permitted without license from IHS www.innotecdt.com
BS EN ISO 7494-2:2003
National foreword
This British Standard is the official English language version of
EN ISO 7494-2:2003. It is identical with ISO 7494-2:2003. Together with
BS EN ISO 7494-1 when published will supersede BS EN ISO 7494:1998 which
will be withdrawn.
The UK participation in its preparation was entrusted by Technical Committee
CH/106, Density, to Subcommittee, CH/106/6, Dental equipment, which has
the responsibility to:
— aid enquirers to understand the text;
— present to the responsible international/European committee any

enquiries on the interpretation, or proposals for change, and keep the
UK interests informed;
— monitor related international and European developments and
promulgate them in the UK.
A list of organizations represented on this subcommittee can be obtained on

request to its secretary.
Cross-references
The British Standards which implement international or European
publications referred to in this document may be found in the BSI Catalogue
under the section entitled “International Standards Correspondence Index”, or
by using the “Search” facility of the BSI Electronic Catalogue or of
British Standards Online.
This publication does not purport to include all the necessary provisions of a
contract. Users are responsible for its correct application.
Compliance with a British Standard does not of itself confer immunity
from legal obligations.
This British Standard was Summary of pages

published under the authority This document comprises a front cover, an inside front cover, the EN ISO title
of the Standards Policy and page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page,
Strategy Committee on pages 1 to 8, the Annex ZA page, and a back cover.
25 March 2003
The BSI copyright date displayed in this document indicates when the
document was last issued.
Amendments issued since publication
Amd. No. Date Comments
14575 14 July 2003 Correction to EN ISO foreword page and

© BSI 14 July 2003 Corrigendum No. 1 addition of Annex ZA page
ISBN 0 580 41458 2

No reproduction or networking permitted without license from IHS
EUROPEAN STANDARD EN ISO 7494-2
NORME EUROPÉENNE
EUROPÄISCHE NORM March 2003
ICS 11.060.20
English version
Dentistry - Dental units - Part 2: Water and air supply (ISO 7494-
2:2003)
Art dentaire - Units dentaires - Partie 2: Alimentation en Zahnheilkunde - Zahnärztliche Behandlungsgeräte - Teil 2:
eau et en air (ISO 7494-2:2003) Wasser- und Luftversorgung (ISO 7494-2:2003)
This European Standard was approved by CEN on 7 February 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovak Republic, Spain, Sweden, Switzerland and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7494-2:2003 E
worldwide for CEN national Members.

EN ISO 7494−2:2003
CORRECTED 2003-06-25
Foreword
This document (EN ISO 7494-2:2003) 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 September 2003, and conflicting national
standards shall be withdrawn at the latest by September 2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of

the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 7494-2:2003 has been approved by CEN as EN ISO 7494-2:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).

EN ISO 7494−2:2003
INTERNATIONAL ISO
STANDARD 7494-2
First edition
2003-03-01
Dentistry — Dental units —

Part 2:
Water and air supply
Art dentaire — Units dentaires —
Partie 2: Alimentation en eau et en air
Reference number
ISO 7494-2:2003(E)

EN ISO 7494−2:2003
IS-4947 O2:(3002E)
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EN ISO 7494−2:2003
Contents Page
Foreword ............................................................................................................................................................ iv
Introduction ........................................................................................................................................................ v
1 Scope...................................................................................................................................................... 1
2 Normative references ........................................................................................................................... 1
3 Terms and definitions........................................................................................................................... 1
4 Requirements for the water supply..................................................................................................... 3
4.1 General ................................................................................................................................................... 3
4.2 Materials used for construction of procedural water systems within the dental unit ................... 3
4.3 Backflow prevention for systems using municipal water................................................................. 4
4.4 Cuspidor................................................................................................................................................. 4
4.5 Water venturi ......................................................................................................................................... 5
4.6 Particle filter .......................................................................................................................................... 5
4.7 Bottled water system supplying incoming water or solution........................................................... 5
4.8 Retraction............................................................................................................................................... 5
4.9 Water-disinfection systems ................................................................................................................. 5
5 Requirements for the air supply.......................................................................................................... 5
5.1 General ................................................................................................................................................... 5
5.2 Particle filters ........................................................................................................................................ 5
5.3 Antibacterial filters................................................................................................................................ 5
6 Tests ....................................................................................................................................................... 6
6.1 Cuspidors............................................................................................................................................... 6
6.2 Water venturi ......................................................................................................................................... 6
6.3 Systems using municipal water .......................................................................................................... 6
6.4 Bottled water system supplying procedural water or solution ........................................................ 6
6.5 Retraction............................................................................................................................................... 6
6.6 Particle filters ........................................................................................................................................ 6
6.7 Antibacterial air filters .......................................................................................................................... 7
6.8 Water-disinfection systems ................................................................................................................. 7
7 Manufacturer's instructions and information for use ....................................................................... 7
Bibliography ....................................................................................................................................................... 8
Copyright British Standards Institution iii

EN ISO 7494−2:2003

EN ISO 7494−2:2003
Introduction
The requirements for water and air supply of dental units have been discussed extensively in
TC 106/SC 6/WG 2, and it was concluded that the technical specifications for the water and air lines within
dental units are sufficiently defined while the microbiological side of the problem is not addressed.
The formulation of criteria in order to avoid or reduce biofilm on the surfaces in water and air lines was
considered difficult. Because the current technical state of the art does not provide an all-inclusive solution, no
agreement could be reached. Therefore it was agreed to publish first the general technical requirements for
the water and air lines as an International Standard. In the next step it is envisaged to find a solution for the
microbiological problems, including evaluation criteria for controlling or removing dental waterline biofilm.
Copyright British Standards Institution v

EN ISO 7494−2:2003
INTENRATIONAL TSANDADR IS-4947 O2:(3002E)
Dentistry — Dental units —

Part 2:
Water and air supply
1 Scope
This part of ISO 7494 specifies requirements and test methods for the materials, design and construction of
the water and air supply within dental units in order to ensure that the compressed water and air supplied via
the dental unit are of appropriate quality. It includes provisions for the prevention of retraction of oral fluids into
the water supply of the dental unit.
This part of ISO 7494 does not address prevention of contamination and/or proliferation of hazardous micro-
organisms (for example bacteria, viruses) in the dental unit.
2 Normative references
The following referenced documents are indispensable for the application 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 7494:1996, Dental units
ISO 11144, Dental equipment — Connections for supply and waste lines
3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.
3.1
procedural water
water supplied by the dental unit for use in the oral cavity
EXAMPLE Handpiece coolant water, syringe water, scaler coolant water or rinse cup water.
3.2
non-procedural water
water supplied by the dental unit for purposes other than use in the oral cavity
EXAMPLE Cuspidor bowl rinse water or water venturi supply water.
3.3
incoming water
water supplied to the dental unit for procedural or non-procedural use
Copyright British Standards Institution 1

EN ISO 7494−2:2003
3.4
incoming solution
solution of substances defined by the manufacturer and introduced in combination with, or in place of, the
incoming water in order to improve or maintain the quality of the procedural water or for other reasons
NOTE Other reasons may be as coolant for cutting burs, medicament for oral cavity, etc.
3.5
bottled water system
water supply system that is based on a reservoir supplying procedural water or solution separately from the
incoming water from the municipal water supplier
3.6
outgoing water
water emerging from the dental unit
3.7
outgoing solution
solution of substances, defined by the manufacturer, emerging from the dental unit in combination with, or in
place of, the outgoing water
3.8
retraction
re-entry of water, air and/or other medium into the dental unit or the dental instruments due to flow reversal
NOTE Retraction may be caused e.g. by momentary dynamic pressure variations during turning off the instruments.
3.9
backflow
flow of water, air and/or another medium back into the municipal water supply via the dental unit
3.10
wastewater
any solution that is discharged into the drainage system from the dental operatory
NOTE Wastewater may be discharged from e.g. the cuspidor, saliva ejector, water separator, amalgam separator.
3.11
incoming-water connection point
any port on the dental unit for connection to a municipal water supply
3.12
wastewater connection point
port for the connection through which wastewater flows and is discharged into the drains
3.13
incoming air
compressed air supplied to the dental unit
3.14
incoming-air connection point
any port on the dental unit for connection to a compressor
3.15
backflow-prevention device
device to prevent backflow
EXAMPLE Pipe disconnector or air gap.
2
EN ISO 7494−2:2003
3.16
cleaning system for suction or wastewater lines
system for cleaning the suction or wastewater lines configured in such a way that the suction or wastewater
tubes are connected to the procedural water supply for flushing
3.17
rinse water
water for cleaning
3.18
spill-over level
highest possible level of water or solution in a device above which the fluid spills over the edge
3.19
water venturi
device using water flow to produce a vacuum
3.20
water-disinfection system
system intended to reduce the number of colony-forming units of bacteria per millilitre of water or solution
3.21
antibacterial filter
filter intended to trap and reduce bacteria in the procedural water or in the compressed air
3.22
dental air
common ambient air available in the dental office, used for dental procedures in the oral cavity of the patient
NOTE This air is different from medical air used for anaesthetic purposes or for surgical purposes (e.g. during
endoscopy).
4 Requirements for the water supply
4.1 General
All connections shall be in accordance with ISO 11144. A schematic diagram of possible water connections in
dental units is given in Figure 1.
4.2 Materials used for construction of procedural water systems within the dental unit
The dental unit shall be designed and constructed so that the materials which come into contact with
procedural water or solutions, or that are likely to come into contact with them, do not cause any adverse
effects on the quality of the procedural water or solution.
For the construction of procedural water or solution lines, only materials which have been approved by water
quality authorities, if available, shall be used.
The materials used within the water path shall be listed together with the respective International Standard
with which they comply, if applicable.
Test in accordance with Clause 7.

EN ISO 7494−2:2003
Key
1 incoming water or procedural solution from a bottled water system
2 wastewater outlet from the cuspidor
3 non-procedural water for the cuspidor
4 wastewater lines within the dental unit
5 procedural water for the cup filler
6 procedural water for dental instruments
7 air for dental instruments
8 water outlet from the suction device
9 wastewater connection point
10 wastewater line
11 incoming-air connection point
12 incoming air
13 incoming water from the municipal water supply
14 incoming-water connection point
Figure 1 — Examples of possible water and air connections in dental units
4.3 Backflow prevention for systems using municipal water
A system using municipal water as procedural water for the dental unit (e.g. for dental instruments, cup fillers),
for cleaning suction or wastewater supply lines and for water-disinfection systems, shall have a backflow-
prevention device at the point of connection with the municipal water supply or an air gap of no less than
20 mm.
Test in accordance with 6.3.
4.4 Cuspidor
The distance of the air gap between the point at which the rinse water for the cuspidor is dispensed and the
spill-over level of the cuspidor with a blocked drain shall be at least 20 mm.
4
EN ISO 7494−2:2003
4.5 Water venturi
Water venturis for suction of saliva and wastewater shall only be used if an additional backflow-prevention
device is installed at the connection point of the water venturi device.
4.6 Particle filter
Except in the case of a bottled water supply, at least one particle filter with an effective mesh size not
exceeding 90 µm shall be installed at the incoming-water connection point in the dental unit in order to prevent
the entry of solid particles from the municipal water supply into the water system.
4.7 Bottled water system supplying incoming water or solution
These systems shall either be completely separate from the municipal water supply system or shall have a
backflow-prevention device at the point of connection with the municipal water supply system.
4.8 Retraction
The volume of the retraction of procedural water or solution shall not exceed 40 mm3 (= 0,04 ml).
4.9 Water-disinfection systems
These systems shall either be completely separate from the municipal water supply system or shall have a
backflow-prevention device at the point of connection with the municipal water supply system.
If a water-disinfection system is installed in a dental unit, it shall be tested in accordance with 6.8.
5 Requirements for the air supply
5.1 General
All connections shall be in accordance with ISO 11144.
A schematic diagram of possible air connections in dental units is given in Figure 1.
5.2 Particle filters
A filter with an effective mesh size not exceeding 25 µm shall be installed at the incoming-air connection point
of the dental unit.
5.3 Antibacterial filters
If antibacterial filters are installed in a dental unit, they shall be tested in accordance with 6.7 and Clause 7 e).

EN ISO 7494−2:2003
6 Tests
6.1 Cuspidors
Check by visual inspection whether the rinse water is dispersed above the spill-over level of the wastewater.
Then measure the distance of the air gap with a measuring device.
6.2 Water venturi
Check by visual inspection that a backflow-prevention device is installed at the connection point of the water
venturi device.
6.3 Systems using municipal water
Check by visual inspection whether a backflow-prevention device or an air gap is installed at the point of
connection with the municipal water supply. Measure the distance of the air gap with a measuring device.
6.4 Bottled water system supplying procedural water or solution
Check by visual inspection if the bottled water system is separate from the municipal water supply. If not,
check by visual inspection if a backflow-prevention device is installed at the point of connection with the
municipal water supply.
6.5 Retraction
To measure the extent of retraction occurring beyond the connection point of the handpiece tubing, connect a
transparent tube of (150 ± 2) mm length and (1,5 ± 0,1) mm internal diameter to the fitting to which the water
tube of the handpiece hose is normally attached. Square off the unconnected end of the transparent tube.
Operate the unit's water valve as would normally be done when shutting off the handpiece. The meniscus of
the column of water in the tube shall not be more than 20 mm from the end of the tube when held vertically,
with the open tube end extending upward.
The use of test tubing with an internal diameter, d, in the range of 0,8 mm to 2,0 mm is also permitted. In
these cases measure the distance l, in millimetres, from the meniscus to the open end of the tube. Then
calculate the volume V, in cubic millimetres, of retracted fluid using the following formula:
V =
( πd l ) 2
where
V is the volume of retracted fluid, in cubic millimetres;
d is the inside diameter of the test tube, in millimetres;
l is the length from the meniscus to the open end of the test tube, in millimetres.
6.6 Particle filters
Check by visual inspection whether a particle filter is installed at the incoming-water and/or -air connection
points. Check the accompanying documents to ensure that all information specified is provided, including
information on the size of the filter mesh.
Check if the specified filter size meets the requirement for water filters in 4.5 or for air filters in 5.2.
6
EN ISO 7494−2:2003
6.7 Antibacterial air filters
Check by visual inspection whether antibacterial filters are installed. Check the accompanying documents to
ensure that all information specified is provided.
6.8 Water-disinfection systems
Check by visual inspection whether water-disinfection systems are installed. Check the accompanying
documents to ensure that all information specified is provided.
7 Manufacturer's instructions and information for use

Dental units shall be accompanied by documents containing relevant information as specified in
ISO 7494:1996, Clause 8. In addition, the following information shall be provided by the manufacturer:
a) a description of the required quality of the incoming water for the dental unit, including the hardness range
of the water;
b) a statement drawing the user's attention to the existence of national regulations, if available, concerning
the quality of water for human use;
c) if a bottled water system is provided, information about decontamination of the reservoir and water lines
or replacement of disposable ones, and information about connecting the water system to the dental unit;
d) the effective filter size and materials of particle filters and instructions for maintenance;
e) if antibacterial air filters are used, information about the method to be used for testing efficacy;
f) if antibacterial air filters are included in the air system of the dental unit, information concerning the
technique for maintenance and replacement of the antibacterial filters;
g) if no water-disinfection system is installed into the dental unit, instructions for maintaining the water
system to ensure that disinfection of the dental unit does not adversely affect the water quality, including
the recommended rinsing and maintenance frequencies;
h) if the dental unit does not prevent the retraction of procedural water into the dental unit, a statement that
only instruments which include anti-retraction devices are to be used together with the dental unit;
i) a statement drawing the user's attention to the existence of applicable regulations regarding backflow
prevention and, if applicable, which provisions for such prevention have been made in the dental unit;
j) a specification of the required quality of the incoming dental air (e.g. free from oil, water, bacteria);
k) a statement drawing the user's attention to the existence of national regulations, if available, concerning
the quality of dental air;
l) if a disinfection system is included in the dental unit, information concerning efficacy and the method to be
used for testing efficacy and instructions on how to use the water-disinfection system.
In addition, information about the materials used for the water path (e.g. a list of materials) shall be made
available to the user on request.

EN ISO 7494−2:2003
Bibliography
[1] ISO 1942-4, Dental vocabulary — Part 4: Dental equipment
8
EN ISO 7494−2:2003
Annex ZA
(normative)
Normative references to international publications

with their relevant European publications
This European Standard i ncorporates b y dat ed or un dated reference, pr ovisions f rom other
publications. These normative references ar e cited at the ap propriate pl aces in the tex t and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this Eur opean St andard on ly whe n inc orporated in it by
amendment or revision. For u ndated r eferences t he l atest edition of th e publication r eferred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 7494 1996 Dental units EN ISO 7494 1997
ISO 11144 1995 Dental equipment – Connections for EN ISO 11144 1996
supply and waste lines

BS EN ISO
7494-2:2003
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BRITISH STANDARD BS EN ISO

The European Standard EN ISO 7494-2:2003 has the status of a

— aid enquirers to understand the text;

— present to the responsible international/European committee any

A list of organizations represented on this subcommittee can be obtained on

This British Standard was Summary of pages

Amendments issued since publication

Amd. No. Date Comments

14575 14 July 2003 Correction to EN ISO foreword page and

ISBN 0 580 41458 2

Copyright British Standards Institution

This European Standard was approved by CEN on 7 February 2003.

EUROPEAN COMMITTEE FOR STANDARDIZATION

Management Centre: rue de Stassart, 36 B-1050 Brussels

Copyright British Standards Institution

According to the CEN/CENELEC Internal Regulations, the national standards organizations of

NOTE Normative references to International Standards are listed in Annex ZA (normative).

Copyright British Standards Institution