SIST EN ISO 7494-2:2015
(Main)Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
This part of ISO 7494 specifies requirements and test methods concerning
a) the configuration of 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 dental unit,
c) the quality for incoming water and air, and
d) the performance of dental unit suction system.
This part of ISO 7494 also specifies requirements for instructions for use and technical description.
This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory
patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are
not included in this International Standard.
Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil 2: Luft, Wasser, Absaugung und Abwassersystem (ISO 7494-2:2015)
Dieser Teil von ISO 7494 legt Anforderungen an und Prüfverfahren für Folgendes fest:
a) Die Konfiguration der Anschlüsse der zahnärztlichen Behandlungseinheit für Druckluftzufuhr, Wasserversorgung, Absaugung und Entleerung der Abwasserrohrleitungen.
b) Die Materialien, Bemessung und Bauweise der Druckluftzufuhr und Wasserversorgung innerhalb der zahnärztlichen Behandlungseinheit.
c) Die Qualität des einströmenden Wassers und der einströmenden Luft.
d) Die Leistungsfähigkeit der Absauggeräte in der zahnärztlichen Behandlungseinheit.
Dieser Teil von ISO 7494 legt auch Anforderungen an die vom Hersteller bereitzustellende Gebrauchs-anweisung, Kennzeichnung, Verpackung und technische Beschreibung fest.
Dieser Teil von ISO 7494 ist auf zahnärztliche Behandlungseinheiten beschränkt, die nicht für die lebens-erhaltende Behandlung stationärer Patienten oder für die kieferchirurgische Behandlung verwendet werden, für die eine Versorgung mit steriler Luft und sterilem Wasser erforderlich ist. Amalgamabscheider sind in dieser Norm nicht enthalten.
Médecine bucco-dentaire - Units dentaires - Partie 2: Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées (ISO 7494-2:2015)
L'ISO 7494-2:2015 spécifie les exigences et les méthodes d'essai concernant:
a) la configuration des branchements de l'unit dentaire 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,
c) la qualité de l'eau et de l'air d'entrée, et
d) la performance du système d'aspiration de l'unit dentaire.
L'ISO 7494-2:2015 spécifie également les exigences relatives aux consignes d'utilisation et à la description technique.
L'ISO 7494-2:2015 se limite aux units dentaires qui ne sont pas utilisés pour le traitement essentiel à la survie des patients ambulatoires ou pour le traitement de chirurgie buccale nécessitant une alimentation en air et en eau stérile. Les séparateurs d'amalgames ne sont pas inclus dans l'ISO 7494-2:2015.
Zobozdravstvo - Zobozdravstvene enote - 2. del: Zrak, voda, sukcija (aspiracija) in sistemi odpadnih voda (ISO 7494-2:2015)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7494-2:2015
01-julij-2015
1DGRPHãþD
SIST EN ISO 11144:2000
SIST EN ISO 7494-2:2003
Zobozdravstvo - Zobozdravstvene enote - 2. del: Zrak, voda, sukcija (aspiracija) in
sistemi odpadnih voda (ISO 7494-2:2015)
Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-
2:2015)
Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil 2: Luft, Wasser, Absaugung
und Abwassersystem (ISO 7494-2:2015)
Médecine bucco-dentaire - Units dentaires - Partie 2: Systèmes d'alimentation en air et
en eau, d'aspiration et d'évacuation des eaux usées (ISO 7494-2:2015)
Ta slovenski standard je istoveten z: EN ISO 7494-2:2015
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 7494-2:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7494-2:2015
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SIST EN ISO 7494-2:2015
EUROPEAN STANDARD
EN ISO 7494-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2015
ICS 11.060.20 Supersedes EN ISO 11144:1996, EN ISO 7494-2:2003
English Version
Dentistry - Dental units - Part 2: Air, water, suction and
wastewater systems (ISO 7494-2:2015)
Médecine bucco-dentaire - Units dentaires - Partie 2: Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil
Systèmes d'alimentation en air et en eau, d'aspiration et 2: Luft, Wasser, Absaugung und Abwassersystem (ISO
d'évacuation des eaux usées (ISO 7494-2:2015) 7494-2:2015)
This European Standard was approved by CEN on 10 January 2015.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7494-2:2015 E
worldwide for CEN national Members.
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SIST EN ISO 7494-2:2015
EN ISO 7494-2:2015 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 7494-2:2015
EN ISO 7494-2:2015 (E)
Foreword
This document (EN ISO 7494-2:2015) 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 October 2015, and conflicting national standards shall be withdrawn at
the latest by October 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7494-2:2003 and EN ISO 11144:1996.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7494-2:2015 has been approved by CEN as EN ISO 7494-2:2015 without any modification.
3
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SIST EN ISO 7494-2:2015
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SIST EN ISO 7494-2:2015
INTERNATIONAL ISO
STANDARD 7494-2
Second edition
2015-04-01
Dentistry — Dental units —
Part 2:
Air, water, suction and wastewater
systems
Médecine bucco-dentaire — Units dentaires —
Partie 2: Systèmes d’alimentation en air et en eau, d’aspiration et
d’évacuation des eaux usées
Reference number
ISO 7494-2:2015(E)
©
ISO 2015
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(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 volume flow rate . 4
5 Requirements . 4
5.1 Requirements for supply connections . 4
5.2 Requirements for water and wastewater systems . 4
5.2.1 Incoming water . 5
5.2.2 Materials used for construction of procedural water systems within the
dental unit. 6
5.2.3 Backflow prevention device for dental units connected to the external
drinking water supply . 7
5.2.4 Cuspidors . . 7
5.2.5 Water venturi . 7
5.2.6 Particle filter . 7
5.2.7 Bacterial filter . 7
5.2.8 Bottled water system supplying procedural water or solution . 7
5.2.9 Retraction . 7
5.2.10 Water disinfection systems . 7
5.2.11 Water sampling connection point . 8
5.2.12 Wastewater drain connection. 8
5.3 Requirements for the air system . 8
5.3.1 Incoming air (dental air) . 8
5.3.2 Particle filters . 8
5.3.3 Bacterial filters . 9
5.4 Requirements for dental unit suction systems . 9
5.4.1 Static vacuum pressure . 9
5.4.2 Head loss . 9
5.4.3 Air separators . 9
5.4.4 Cannula connectors and cannula . 9
5.4.5 Operating hoses with cannula connectors .10
5.4.6 Solids filter .11
5.4.7 Noise level .11
5.4.8 Dental unit suction source connection point .11
6 Sampling .11
7 Tests .11
7.1 Cuspidors .11
7.2 Water venturi .11
7.3 Systems directly connected to external drinking water supply .11
7.4 Bottled water system supplying procedural water or solution .11
7.5 Retraction .12
7.6 Particle filters .12
7.7 Bacterial filters .12
7.8 Water disinfection systems .12
7.9 Tests for dental unit suction systems .13
7.9.1 Static vacuum pressure test .13
7.9.2 Head loss test .13
7.9.3 Measurement of noise level .14
© ISO 2015 – All rights reserved iii
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(E)
7.10 Water sampling connection point .15
7.11 Incoming water and air quality .15
7.12 Supply connections .15
8 Manufacturer’s instructions for use .15
9 Technical description .16
Annex A (informative) Schematic diagram of possible components and connections in a
dental unit .18
Annex B (informative) Test sequences .20
Bibliography .25
iv © ISO 2015 – All rights reserved
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.
This edition of ISO 7494-2 cancels and replaces ISO 7494-2:2003 and ISO 11144, of which it constitutes a
technical revision, while only replacing certain requirements specific to dental units given in ISO 10637.
In addition, it consolidates and updates requirements formerly specified in
— ISO 10637:1999, Dental equipment — High- and medium-volume suction systems, and
— ISO 11144:1995, Dental equipment — Connections for supply and waste lines.
ISO 7494 consists of the following parts, under the general title Dentistry — Dental units:
— Part 1: General requirements and test methods
— Part 2: Air, water, suction and wastewater systems
© ISO 2015 – All rights reserved v
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(E)
Introduction
This part of ISO 7494 specifies requirements and test methods pertaining to components of the dental
unit which convey air, water, suction, and wastewater. The requirements in this part of ISO 7494
focus on certain technical aspects regarded by the working group to be appropriate for international
standardization. The working group acknowledges that requirements for microbiological aspects of
the fluids transported by dental units are also worthy of standardization and is working to develop
requirements pertaining to the prevention, inhibition, and removal of dental unit waterline biofilm.
Additional projects to develop microbiological requirements for air, water, and/or suction may follow.
vi © ISO 2015 – All rights reserved
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SIST EN ISO 7494-2:2015
INTERNATIONAL STANDARD ISO 7494-2:2015(E)
Dentistry — Dental units —
Part 2:
Air, water, suction and wastewater systems
1 Scope
This part of ISO 7494 specifies requirements and test methods concerning
a) the configuration of 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 dental unit,
c) the quality for incoming water and air, and
d) the performance of dental unit suction system.
This part of ISO 7494 also specifies requirements for instructions for use and technical description.
This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory
patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are
not included in this International Standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 7494-1:2011, Dentistry — Dental units — Part 1: General requirements and test methods
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 10637:1999, Dental equipment — High- and medium-volume suction systems
ISO 14971, Medical devices — Application of risk management to medical devices
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366, Medical devices — Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and ISO 7494-1 and the
following apply.
3.1
air separator
apparatus which separates liquids and solids from the suction air
© ISO 2015 – All rights reserved 1
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(E)
3.2
bacterial filter
filter designed to restrict the passage of bacteria and reduce bacteria in the procedural water or in the
compressed air
3.3
backflow
flow of water and/or another medium back into the external drinking water supply
3.4
backflow prevention device
safety device to prevent backflow
3.5
bottled water system
dental unit water system in which procedural water is supplied by an included reservoir which is not
connected to an external drinking water supply system and is manually filled with incoming water or
incoming solution
3.6
cannula connector
component at the end of the dental suction operating hose, which joins the cannula to the operating hose
3.7
dental air
compressed air supplied through the dental unit for powering, controlling, and/or assisting various
dental instruments 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
3.8
dental treatment centre
combination of functional items for dental use which consist, for example, of dental unit, dental patient
chair, and interconnected sub-units of dental equipment and instruments providing a functional
environment for dental care
3.9
dental unit suction system
passive entity, including all the components from the dental unit suction source connection point through the
cannula connector, which can induce air flow when connected to a suction source to evacuate solids, liquids,
aerosols and gases from the oral cavity and immediate surrounding area during oral treatment procedures
3.10
dental unit suction source connection point
any port on the dental unit for connection to a supply of dental suction
3.11
filter
apparatus which restricts targeted constituents from passing through it
3.12
incoming air
compressed air supplied to the dental unit
3.13
incoming air connection point
any port on the dental unit for connection to an external compressed air supply
2 © ISO 2015 – All rights reserved
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(E)
3.14
incoming solution
solution of substances specified 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, such as coolant for cutting burs or medicament for oral cavity
3.15
incoming water
water supplied to the dental unit for procedural use or non-procedural use
3.16
incoming water connection point
any port on the dental unit for connection to an external drinking water supply
3.17
non-procedural water
water supplied by the dental unit for purposes other than use in the oral cavity
EXAMPLE Cuspidor bowl rinse water, water venturi supply water.
3.18
procedural water
water supplied by the dental unit for use in the oral cavity
EXAMPLE Handpiece coolant water, multifunction handpieces (syringes) water, scaler coolant water, cup fill
water.
3.19
retraction
re-entry of water, air, and/or other medium into the dental unit or the dental instruments due to flow
reversal, e.g. caused by momentary dynamic pressure variations during turning off the instruments
3.20
rinse water
water for cleaning
3.21
spill-over level
highest possible level of water or solution in a device above which the fluid will flow over the edge
3.22
suction system
active entity of dental equipment, including a suction source equipment, which enables an air flow to
be induced which is designed to remove spray, liquids, and solids from the mouth of the dental patient
during dental treatment
3.23
wastewater
solution that is discharged into the drainage system by way of the cuspidor drain, saliva ejector, air
separator, amalgam separator, or other dental unit component or system
3.24
water disinfection system
system designed to reduce the microbiological contamination in a dental unit procedural water
3.25
water venturi
device using waterflow to produce a suction
3.26
wastewater connection point
port for the connection through which wastewater flows and is discharged into the drains
© ISO 2015 – All rights reserved 3
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SIST EN ISO 7494-2:2015
ISO 7494-2:2015(E)
4 Classification
4.1 Classification of suction systems
According to ISO 10637:1999, suction systems are classified to the type of suction as follows:
a) dry system;
b) semi-dry system;
c) wet system.
4.2 Classification of suction air volume flow rate
According to ISO 10637:1999, suction systems are classified to the type of air volume flow rate as follows:
1)
a) type 1: high-volume suction system, suction system with an air intake of more than 250 Nl/min at
the suction cannula connector;
b) type 2: medium-volume suction system, suction system with an air intake between 90 Nl/min and
1)
250 Nl/min at the suction cannula connector.
5 Requirements
5.1 Requirements for supply connections
The manufacturer’s technical description shall include the configuration of the supply connections for
the dental unit. The specified configuration of the supply connections shall lie within a maximum area
of 180 mm × 220 mm.
The manufacturer’s technical description shall include detailed information of the position and
the dimensions of supply connections (see keys 1 to 5 in Figure 1) for the dental unit in the dental
treatment centre.
In the dental treatment centre, 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 keys 4 and 5 in Figure 1)
are given as maximum values.
Dimensions for plumbing holes (see keys 1, 2, and 3 in Figure 1) 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.
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.
This test is in accordance with 7.12.
5.2 Requirements for water and wastewater systems
NOTE A schematic diagram of possible water and wastewater systems is given as example in Figure A.1.
1) Nl/min indicates normal litres per minute, the amount of air that flows through a pipe calculated back to
2 5 2
“normal” conditions [0 °C a
...
SLOVENSKI STANDARD
oSIST prEN ISO 7494-2:2013
01-julij-2013
=RER]GUDYVWYR=RER]GUDYVWYHQHHQRWHGHO 0HGLMVNLNDQDOLLQSULNOMXþNL
,62',6
Dentistry - Dental units - Part 2: Media channels and connections (ISO/DIS 7494-2:2013)
Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil 2: Medienkanäle und
Anschlüsse (ISO/DIS 7494-2:2013)
Médecine bucco-dentaire - Units dentaires - Partie 2: Alimentation en eau et en air
(ISO/DIS 7494-2:2013)
Ta slovenski standard je istoveten z: prEN ISO 7494-2 rev
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
oSIST prEN ISO 7494-2:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 7494-2:2013
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oSIST prEN ISO 7494-2:2013
EUROPEAN STANDARD
DRAFT
prEN ISO 7494-2 rev
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2013
ICS 11.060.25 Will supersede EN ISO 11144:1996, EN ISO 7494-2:2003
English Version
Dentistry - Dental units - Part 2: Media channels and
connections (ISO/DIS 7494-2:2013)
Médecine bucco-dentaire - Units dentaires - Partie 2: Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil
Alimentation en eau et en air (ISO/DIS 7494-2:2013) 2: Medienkanäle und Anschlüsse (ISO/DIS 7494-2:2013)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 55.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 7494-2 rev:2013: E
worldwide for CEN national Members.
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oSIST prEN ISO 7494-2:2013
prEN ISO 7494-2:2013 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 7494-2:2013
prEN ISO 7494-2:2013 (E)
Foreword
This document (prEN ISO 7494-2:2013) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 11144:1996, EN ISO 7494-2:2003.
Endorsement notice
The text of ISO/DIS 7494-2:2013 has been approved by CEN as prEN ISO 7494-2:2013 without any
modification.
3
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oSIST prEN ISO 7494-2:2013
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oSIST prEN ISO 7494-2:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 7494-2
ISO/TC 106/SC 6 Secretariat: DIN
Voting begins on Voting terminates on
2013-03-28 2013-08-28
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Dentistry — Dental units —
Part 2:
Media channels and connections
Médecine bucco-dentaire — Units dentaires —
Partie 2: Alimentation en eau et en air
[Revision of first edition (ISO 11144:1995) and first edition of ISO 7494-2:2003]
ICS 11.060.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
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© International Organization for Standardization, 2013
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oSIST prEN ISO 7494-2:2013
ISO/DIS 7494-1
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© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
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ii © ISO 2013 – All rights reserved
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oSIST prEN ISO 7494-2:2013
ISO/DIS 7494-2
Contents Page
Foreword . v
Introduction . vi
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Classification . 10
4.1 Classification of suction systems . 10
4.2 Classification of suction air volume flow rate . 10
5 Requirements . 11
5.1 Requirements for supply connections . 11
5.2 Requirements for the water supply . 11
5.2.1 Water quality . 11
5.2.2 Materials used for construction of procedural water systems within the dental unit. 13
5.2.3 Backflow prevention device for dental units using external drinking-water . 13
5.2.4 Cuspidors . 13
5.2.5 Water venturi . 13
5.2.6 Particle filter . 13
5.2.7 Antibacterial filters . 13
5.2.8 Bottled water system supplying incoming water or solution . 13
5.2.9 Retraction . 14
5.2.10 Water disinfection systems . 14
5.2.11 Water sampling connection point . 14
5.2.12 Waste water drain connection . 14
5.3 Requirements for the air supply . 14
5.3.1 Air quality (dental air) . 14
5.3.2 Particle filters . 15
5.3.3 Antibacterial filters . 15
5.4 Requirements for suction devices . 15
5.4.1 Maximum static vacuum pressure . 15
5.4.2 Flow performance . 15
5.4.3 Air separators . 15
5.4.4 Requirements for accessories . 16
5.4.5 Noise level . 17
5.4.6 Suction connection point . 17
6 Sampling. 18
7 Tests . 18
7.1 Cuspidors . 18
7.2 Water venturi . 18
7.3 Systems using municipal water . 18
7.4 Bottled water system supplying procedural water or solution . 18
7.5 Retraction . 18
7.6 Particle filters . 18
7.7 Antibacterial filters . 18
7.8 Water disinfection systems . 19
7.9 Tests for dental unit suction devices . 19
7.9.1 Static vacuum pressure test. 19
7.9.2 Flow characterization test . 20
7.9.3 Measurement of noise level . 22
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7.9.4 Water sampling connection point . 22
7.10 Air supply quality (dental-air) . 22
7.11 Supply connections . 22
8 Manufacturer's instructions for use . 22
9 Technical description . 23
Annex A (informative) Schematic diagram of possible devices and connections in dental units
(example) . 24
Annex B (informative) Test sequences . 26
Bibliography .8
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oSIST prEN ISO 7494-2:2013
ISO/DIS 7494-2
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 7494-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 7494-2:2003, ISO 11144:1995), which have
been technically revised.
ISO 7494 consists of the following parts, under the general title Dentistry — Dental units:
Part 2: Part 1: General requirements and test methods
Part 2: Media channels and connections
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oSIST prEN ISO 7494-2:2013
ISO/DIS 7494-2
Introduction
This part of ISO 7494 is a combination of the following two International Standards:
ISO 7494-2:2003-03, Dentistry - Dental units - Part 2: Water and air supply
ISO 11144:1995-05-01, Dental equipment – Connections for supply and waste lines
This part of ISO 7494 specifies requirements and test methods pertaining to components of the dental unit
which deliver air, water, suction and waste, as well as the effects that these components have on the delivery
of air, water, suction and waste. This revision consolidates and updates requirements, which formerly were
specified in the following three standards:
ISO 7494-2:2003 Dentistry – Dental units – Part 2: Water and air supply
ISO 10637:1999 Dental equipment – High- and medium-volume suction systems
ISO 11144:1995 Dental equipment – Connections for supply and waste lines
This revision entirely replaces ISO 7494-2:2003 and ISO 11144:1995, while it only replaces certain
requirements specific to dental units in ISO 10637.
The requirements in this part of ISO 7494 focus on certain technical aspects regarded by the working group to
be appropriate for international standardization. The working group acknowledges that requirements for
microbiological aspects of the fluids transported by dental units are also worthy of standardization and is
working to develop requirements pertaining to the prevention, inhibition and removal of dental unit waterline
bio film. Additional projects to develop microbiological requirements for air, water and/or suction may follow.
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oSIST prEN ISO 7494-2:2013
ISO/DIS 7494-2
Dentistry — Dental units — Part 2: Media channels and
connections
1 Scope
This part of ISO 7494 specifies requirements and test methods concerning:
a) The configuration of dental unit connections to the compressed air supply, water supply, suction
supply and waste water drain plumbing.
b) The materials, design and construction of the compressed air and water supply within the dental
unit.
c) The quality for incoming water and air.
d) The performance of dental unit suction devices in a dental unit.
This part of ISO 7494 also specifies requirements for instructions for use, marking, packaging and
technical description that is to be provided by the manufacturer.
This part of ISO 7494 is limited to dental units that are not used for life support treatment of ambulatory
patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not
included in this Standard.
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 1942, Dentistry —Vocabulary / Note: Corrected and reprinted in 2010-03-01
ISO 7494-1, Dentistry — Dental units — Part 1: General requirements and test methods
ISO 8573-1:2010, Compressed air — Part 1: Contaminants and purity classes
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 10637, Dental equipment — High- and medium volume suction systems
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366, Medical devices — Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
accessories
cannula, manifold, filter and/or mobile support
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3.2
air separator
apparatus which separates liquids and solids from the suction air
3.3
antibacterial filter
filter designed to trap bacteria and reduce bacteria in the procedural water or in the compressed air
3.4
backflow
flow of water and/or another medium back into the external water supply
3.5
backflow prevention device
device to prevent water backflow
3.6
bottled water system
water supply system that is based on a reservoir supplying procedural water or solution separately from
the incoming water from other sources
3.7
cannula connector
component at the end of the dental suction operating hose, which joins the cannula to the operating hose
3.8
cleaning system for suction or waste water lines
a system for cleaning the suction or waste water lines configured in such a way that the suction or waste
water tubes are connected to the water supply or other solution supply for flushing
3.9
dental air
compressed air supplied to the dental unit for powering, controlling and/or assisting various dental
instruments and equipment, as well as for assisting practitioners with procedures in the oral cavity, but
not for procedures requiring medical air or sterile air
EXAMPLE Endoscopy, oral surgery, analgesia, life support.
3.10
dental treatment centre
combination of functional items for dental use which consist, for example, of dental unit, dental patient
chair and interconnected sub-units of dental equipment and instruments providing a functional
environment for dental care
3.11
dental unit suction device
passive entity which can only induce an air flow when connected to a suction machine, including all the
components from the dental unit suction source connection point to the cannula connector
3.12
dental unit suction source connection point
any port on the dental unit for connection to a supply of dental suction
3.13
filter
apparatus which retains solids from the air and liquids passing through it
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3.14
high volume suction system
suction system with an air intake of more than 250 litres per minute (Nl/min) in each suction handpiece/-
cannula
3.15
incoming air
compressed air supplied to the dental unit
3.16
incoming air connection point
any port on the dental unit for connection to a compressor
3.17
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
EXAMPLE Coolant for cutting burs, medicament for oral cavity.
3.18
incoming water
water supplied by an external source to the dental unit for procedural use or non-procedural use
3.19
incoming water connection point
any port on the dental unit for connection to an external water supply
3.20
medium-volume suction system
suction system with an air intake between 90 Nl/min and 250 Nl/min in each suction handpiece/-cannula
3.21
non-procedural water
water supplied by the dental unit for purposes other than use in the oral cavity (cuspidor bowl rinse water,
water venturi supply water)
3.22
outgoing solution
solution of substances defined by the manufacturer emerging from the dental unit in combination with, or
in place of, the outgoing water
3.23
outgoing water
water emerging from the dental unit
3.24
procedural water
water supplied by the dental unit for use in the oral cavity
EXAMPLE Handpiece coolant water, syringe water, scaler coolant water, cupfill water.
3.25
retraction
re-entry of water, air, and/or other medium into the dental unit or the dental instruments due to flow
reversal, e.g. caused by momentary dynamic pressure variations during turning off the instruments
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3.26
rinse water
water for cleaning
3.27
spill-over level
highest possible level of water or solution in a device above which the fluid will flow over the edge
3.28
suction system
active entity of dental equipment, including a suction machine, which enables an air flow to be induced
which is designed to remove spray, liquids and solids from the mouth of the dental patient during dental
treatment
3.29
waste water
any solution that is discharged into the drainage system from the dental unit
EXAMPLE Cuspidor, saliva ejector, water separator, amalgam separator.
3.30
water disinfection system
a system designed to reduce the number of colony forming units per millilitre water or solution (CFU/ml)
3.31
water venturi
a device using waterflow to produce a suction
3.32
waste water connection point
port for the connection through which waste water flows and is discharged into the drains
4 Classification
4.1 Classification of suction systems
Suction systems are classified to the type of suction as following:
a) Dry system
b) Semi-dry system
c) Wet system
According to ISO 10637:1999.
4.2 Classification of suction air volume flow rate
Suction systems are classified to the type of air volume flow rate as following:
a) Type 1: High-volume suction system
b) Type 2; Medium-volume suction system
c) Type 3; Low-volume suction system
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oSIST prEN ISO 7494-2:2013
ISO/DIS 7494-2
According to ISO 10637:1999.
5 Requirements
5.1 Requirements for supply connections
The manufacturer’s instruction shall include the configuration of the supply connections for the dental unit
in a maximum area of 180 mm x 220 mm.
The manufacturer’s instructions shall include detailed information of the position of supply connections at
the domestic installation. An example of the configuration and the connection points is given in Figure 1.
Dimensions for the connections for electricity and compressed air areas (Figure 1, Key 4 and 5) are given
as maximum values.
NOTE At the domestic installation 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.
Dimensions for plumbing holes (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 may be positioned anywhere inside the connection area.
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 7.11.
5.2 Requirements for the water supply
NOTE A schematic diagram of possible water connections in dental units is given as example in Figure A. 1.
5.2.1 Water quality
The following incoming water quality is recommended:
a) Water pressure: 2 bar to 6 bar
b) Water quantity: < 5 l/min
c) Water hardness: from 1,5 mmol/l up to 2,14 mmol/l (= 8,4 dH - 12 dH)
d) pH-value: 6,5 to 8,5
e) Drinking-water quality
f) Water filter size outside of the dental unit: < 80 µm
The manufacturer’s instructions shall specify the required water quality of the incoming water.
Test in accordance with 7.11.
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ISO/DIS 7494-2
Dimensions in millimetres
Key
1 Waste water connection point
2 Incoming water connection point
3 Dental unit suction source connection point
4 Connection area for electricity and telecommunication
5 Connection area for Incoming air
Figure 1 — Configuration example of connection points and adjacent supply areas
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oSIST prEN ISO 7494-2:2013
ISO/DIS 7494-2
5.2.2 Materials used for construction of procedural water systems within the dental unit
The dental unit shall be designed and constructed in such way that the materials which come into contact
with procedural wat
...
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