SIST EN ISO 5467-2:2023
(Main)Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 5467-2:2022)
Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 5467-2:2022)
This document specifies requirments and test methods for moblie dental units concerning air and water quality.
Zahnheilkunde - Mobile Behandlungseinheiten und Patientenliegen - Teil 2: Luft, Wasser, Absaugung und Abwasser (ISO 5467-2:2022)
Dieses Dokument legt Anforderungen und Prüfverfahren für mobile dentale Behandlungseinheiten fest für
a) die Eigenschaften der Anschlüsse der mobilen dentalen Behandlungseinheiten zur Druckluftversorgung, Wasserversorgung, Absaugung und zu den Abwasserrohrleitungen,
b) die Materialien, Gestaltung und Bauweise der Druckluft- und Wasserversorgung innerhalb der mobilen dentalen Behandlungseinheit,
c) die Qualität des einströmenden Wassers und der einströmenden Luft,
d) die Leistungsfähigkeit des Absaugsystems in der mobilen dentalen Behandlungseinheit, und
e) die Luft-, Wasser-, Absaugungs- und Abwassereigenschaften von mobilen dentalen Behandlungseinheiten an den Schnittstellen zu dentalen Handstücken.
Dieses Dokument legt auch Anforderungen an die Gebrauchsanweisung und an die Technische Beschreibung fest.
Dieses Dokument beschränkt sich auf mobile 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 et fauteuils dentaires patient mobiles - Partie 2: Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées (ISO 5467-2:2022)
Le présent document spécifie les exigences et les méthodes d’essai applicables aux units dentaires mobiles concernant:
a) les propriétés des branchements des units dentaires mobiles 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 mobile,
c) la qualité de l’eau et de l’air d’entrée,
d) la performance du système d’aspiration de l'unit dentaire mobile, et
e) les propriétés de l’air, de l'eau, de l’aspiration et des eaux usées des branchements des units dentaires mobiles aux interfaces des pièces à main dentaires.
Le présent document spécifie également les exigences relatives aux instructions d'utilisation et à la description technique.
Le présent document est uniquement applicable aux units dentaires mobiles qui ne sont pas utilisés pour le traitement de chirurgie buccale nécessitant une alimentation en eau et en eau stérile. Les dispositifs de récupération de l’amalgame ne sont pas inclus dans le présent document.
Zobozdravstvo - Mobilne dentalne enote in stoli za paciente - 2. del: Sistemi za dovod zraka in vode, za sukcijo (aspiracijo) in odvod odpadne vode (ISO 5467-2:2022)
Ta dokument določa zahteve in preskusne metode za brizge za mobilne dentalne enote v zvezi s kakovostjo zraka in vode.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5467-2:2023
01-januar-2023
Zobozdravstvo - Mobilne dentalne enote in stoli za paciente - 2. del: Sistemi za
dovod zraka in vode, za sukcijo (aspiracijo) in odvod odpadne vode (ISO 5467-
2:2022)
Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and
wastewater systems (ISO 5467-2:2022)
Zahnheilkunde - Mobile Behandlungseinheiten und Patientenliegen - Teil 2: Luft, Wasser,
Absaugung und Abwasser (ISO 5467-2:2022)
Médecine bucco-dentaire - Units dentaires et fauteuils dentaires patient mobiles - Partie
2: Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées
(ISO 5467-2:2022)
Ta slovenski standard je istoveten z: EN ISO 5467-2:2022
ICS:
11.060.20 Zobotehnična oprema Dental equipment
SIST EN ISO 5467-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5467-2:2023
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SIST EN ISO 5467-2:2023
EN ISO 5467-2
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Mobile dental units and dental patient chairs -
Part 2: Air, water, suction and wastewater systems (ISO
5467-2:2022)
Médecine bucco-dentaire - Units dentaires et fauteuils Zahnheilkunde - Mobile Behandlungseinheiten und
dentaires patient mobiles - Partie 2: Systèmes Patientenliegen - Teil 2: Luft, Wasser, Absaugung und
d'alimentation en air et en eau, d'aspiration et Abwasser (ISO 5467-2:2022)
d'évacuation des eaux usées (ISO 5467-2:2022)
This European Standard was approved by CEN on 6 September 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5467-2:2022 E
worldwide for CEN national Members.
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SIST EN ISO 5467-2:2023
EN ISO 5467-2:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 5467-2:2023
EN ISO 5467-2:2022 (E)
European foreword
This document (EN ISO 5467-2:2022) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2023, and conflicting national standards shall be
withdrawn at the latest by April 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 5467-2:2022 has been approved by CEN as EN ISO 5467-2:2022 without any
modification.
3
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SIST EN ISO 5467-2:2023
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SIST EN ISO 5467-2:2023
INTERNATIONAL ISO
STANDARD 5467-2
First edition
2022-09
Dentistry — Mobile dental units and
dental patient chairs —
Part 2:
Air, water, suction and wastewater
systems
Médecine bucco-dentaire — Units dentaires et fauteuils dentaires
patient mobiles —
Partie 2: Systèmes d'alimentation en air et en eau, d'aspiration et
d'évacuation des eaux usées
Reference number
ISO 5467-2:2022(E)
© ISO 2022
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SIST EN ISO 5467-2:2023
ISO 5467-2:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 5467-2:2023
ISO 5467-2:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
4.1 Classification of dental air supply . 2
4.2 Classification of suction system and suction air flow rate . 2
5 Requirements . 2
5.1 Connections from the mobile dental unit to dental handpiece . 2
5.2 Supply connections to the mobile dental unit . 3
5.3 Water and wastewater systems . 3
5.3.1 Incoming water and bottled water . 3
5.3.2 Materials used for construction of procedural water systems within the
mobile dental unit . 3
5.3.3 Backflow prevention device for mobile dental units connected to the
external drinking water supply . 3
5.3.4 Cuspidors . . 4
5.3.5 Water venturi . 4
5.3.6 Particle filter . 4
5.3.7 Bacterial filter . 4
5.3.8 Bottled water system supplying procedural water or solution . 4
5.3.9 Retraction . 4
5.3.10 Treatment method for biofilm . 4
5.3.11 Water sampling connection point . 4
5.3.12 Wastewater drain connection . 5
5.3.13 Wastewater container . 5
5.4 Air system . 5
5.4.1 Incoming dental air . 5
5.4.2 Purity class of dental air supplied by an integrated compressed air source
equipment . 5
5.4.3 Particle filters . 5
5.4.4 Bacterial filters . 5
5.4.5 Condensate drain . 5
5.4.6 Compressed air filter . 5
5.4.7 Sound level of compressed air source equipment . 6
5.5 Mobile dental unit suction systems . 6
5.5.1 Maximum suction pressure . 6
5.5.2 Suction pressure head loss . 6
5.5.3 Configuration of cannula connectors and cannula . 6
5.5.4 Operating hoses with cannula connectors . 6
5.5.5 Solids filter . 6
5.5.6 Air separator . 6
5.5.7 Mobile dental unit suction source connection point . 6
5.5.8 Suction flow rate . 7
5.5.9 Bacterial filter . 7
5.6 Test report . 7
6 Sampling . 7
7 Measurement and test methods .7
7.1 Visual inspection . 7
7.1.1 Visual inspection of equipment . 7
7.1.2 Visual inspection of documentation or test reports . . 7
iii
© ISO 2022 – All rights reserved
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SIST EN ISO 5467-2:2023
ISO 5467-2:2022(E)
7.2 Particle filters test . 8
7.3 Suction flow rate test . 8
8 Instructions for use . .8
9 Technical description .8
Annex A (informative) Test report. 9
Bibliography .13
iv
© ISO 2022 – All rights reserved
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SIST EN ISO 5467-2:2023
ISO 5467-2:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6,
Dental equipment, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 5467 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
© ISO 2022 – All rights reserved
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SIST EN ISO 5467-2:2023
ISO 5467-2:2022(E)
Introduction
This document was developed in consideration of ISO 7494-2:2022, so as to be applicable to mobile
dental units. The requirements in this document focus on certain technical aspects to be appropriate for
international standardization. The requirements for microbiological aspects of the fluids transported
by mobile dental units are acknowledged to be also worthy of standardization and requirements
pertaining to the prevention, inhibition, and removal of mobile dental unit waterline biofilm are being
developed.
vi
© ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 5467-2:2023
INTERNATIONAL STANDARD ISO 5467-2:2022(E)
Dentistry — Mobile dental units and dental patient
chairs —
Part 2:
Air, water, suction and wastewater systems
1 Scope
This document specifies the requirements and test methods for mobile dental units concerning:
a) the properties of mobile 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 mobile
dental unit,
c) the quality for incoming water and air,
d) the performance of mobile dental unit suction system, and
e) the air, water, suction and wastewater properties of mobile dental unit connections to the interfaces
to dental handpieces.
This document also specifies requirements for instructions for use and a technical description.
This document is only applicable to mobile 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 5167-1, Measurement of fluid flow by means of pressure differential devices inserted in circular cross-
section conduits running full — Part 1: General principles and requirements
ISO 5467-1, Dentistry — Mobile dental units and dental patient chairs —Part 1: General requirements
ISO 7494-2:2022, Dentistry — Stationary dental units and dental patient chairs — Part 2: Air, water,
suction and wastewater systems
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 10637, Dentistry — Ce
...
SLOVENSKI STANDARD
oSIST prEN ISO 5467-2:2022
01-februar-2022
Zobozdravstvo - Mobilne zobozdravstvene enote in stoli za paciente - 2. del:
Sistemi za dovod zraka in vode, za sukcijo (aspiracijo) in odvod odpadne vode
(ISO/DIS 5467-2:2021)
Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and
wastewater systems (ISO/DIS 5467-2:2021)
Zahnheilkunde - Mobile Behandlungseinheiten und Patientenliegen - Teil 2: Luft,
Wasser, Absaugung und Abwasser (ISO/DIS 5467-2:2021)
Médecine bucco-dentaire - Units dentaires et fauteuils dentaires patient mobiles - Partie
2: Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées
(ISO/DIS 5467-2:2021)
Ta slovenski standard je istoveten z: prEN ISO 5467-2
ICS:
11.060.20 Zobotehnična oprema Dental equipment
oSIST prEN ISO 5467-2:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 5467-2:2022
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oSIST prEN ISO 5467-2:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5467-2
ISO/TC 106/SC 6 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-12-01 2022-02-23
Dentistry — Mobile dental units and dental patient
chairs —
Part 2:
Air, water, suction and wastewater systems
ICS: 11.060.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 5467-2:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 Connections from the mobile dental unit to dental handpiece . 2
5.2 Supply connections to the mobile dental unit . 2
5.3 Water and wastewater systems . 2
5.3.1 Incoming water . 2
5.3.2 Materials used for construction of procedural water systems within the
mobile dental unit . 3
5.3.3 Backflow prevention device for mobile dental units connected to the
external drinking water supply . 3
5.3.4 Cuspidors . . 3
5.3.5 Water venturi . 3
5.3.6 Particle filter . 3
5.3.7 Bacterial filter . 3
5.3.8 Bottled water system supplying procedural water or solution . 4
5.3.9 Retraction . 4
5.3.10 Treatment method for biofilm . 4
5.3.11 Water sampling connection point . 4
5.3.12 Wastewater drain connection . 4
5.4 Air system . 4
5.4.1 Incoming dental air . 4
5.4.2 Particle filters . 4
5.4.3 Bacterial filters . 4
5.4.4 Condensate drain . 5
5.4.5 Compressed air filter . 5
5.5 Mobile dental unit suction systems . 5
5.5.1 Maximum suction pressure . 5
5.5.2 Suction pressure head loss . 5
5.5.3 Configuration of cannula connectors and cannula . 5
5.5.4 Operating hoses with cannula connectors . 5
5.5.5 Solids filter . 5
5.5.6 Air separator . 5
5.5.7 Mobile dental unit suction source connection point . 5
5.5.8 Suction flow rate . 6
5.5.9 Bacterial filter . 6
5.6 Test report . 6
6 Sampling . 6
7 Measurement and test methods .6
7.1 Visual inspection . 6
7.1.1 Visual inspection of equipment . 6
7.1.2 Visual inspection of documentation or test reports . . 6
7.2 Dental handpiece connection test . 6
7.2.1 Apparatus . 6
7.2.2 Procedure . 7
7.3 Systems directly connected to external drinking water supply test . 9
7.4 Cuspidor test . 9
7.5 Particle filters test . 9
iii
© ISO 2021 – All rights reserved
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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
7.6 Retraction test . 9
7.7 Mobile dental unit suction systems test . 10
7.7.1 Static suction pressure test . 10
7.7.2 Suction pressure head loss test . 11
7.8 Suction flow rate test .12
8 Instructions for use . .12
9 Technical description .13
Annex A (informative) Test report.15
Bibliography .21
iv
© ISO 2021 – All rights reserved
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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(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 first edition was developed in consideration of ISO 7494-2:20XX to be applicable to mobile dental
units.
A list of all parts in the ISO 5467 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
© ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
Introduction
This document specifies requirements and test methods pertaining to components of mobile 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 by mobile
dental units are also worthy of standardization and is working to develop requirements pertaining to
the prevention, inhibition, and removal of mobile dental unit waterline biofilm. Additional projects to
develop microbiological requirements for air, water, and/or suction may follow.
vi
© ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 5467-2:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 5467-2:2021(E)
Dentistry — Mobile dental units and dental patient
chairs —
Part 2:
Air, water, suction and wastewater systems
1 Scope
This document specifies requirements and test methods of mobile dental units concerning
a) the properties of mobile 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 mobile
dental unit,
c) the quality for incoming water and air,
d) the performance of mobile dental unit suction system, and
e) the air, water, suction and wastewater properties of mobile dental unit connections to the interfaces
to dental handpieces.
This document also specifies requirements for instructions for use and technical description.
This document is limited to mobile 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, 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 5167-1, Measurement of fluid flow by means of pressure differential devices inserted in circular cross-
section conduits running full — Part 1: General principles and requirements
ISO 5467-1, Mobile dental units and dental patient chairs —Part 1: General requirements
ISO 7494-2:20XX, Dentistry — Stationary dental units and dental patient chairs — Part 2: Air, water,
suction and wastewater systems
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 5467-1, ISO 7494-2,
ISO 10637, ISO 22052 and the following apply.
1
© ISO 2021 – All rights reserved
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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(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
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3.1
mobile dental unit suction system
components located between the facility suction pipeline connection point and the cannula connector
that are part of the mobile dental unit which enable 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
Note 1 to entry: Suction source equipment may be included in mobile dental unit, in which case no facility suction
pipeline connection point exists.
3.2
mobile dental unit suction source connection point
any port on the mobile dental unit for connection to a supply of dental suction
4 Classification
Clause 4 of ISO 7494-2:20XX applies.
5 Requirements
5.1 Connections from the mobile dental unit to dental handpiece
The requirements specified in 5.1 of ISO 7494-2:20XX applies by replacing stationary dental unit with
mobile dental unit.
Test in accordance with 7.1.
5.2 Supply connections to the mobile dental unit
Technical description shall include the configuration of the supply connections for the mobile dental
unit, if applicable.
NOTE Some mobile dental units do not have any supply connection other than an electrical power supply
cable.
The location of other utility connections which are not indicated shall be specified by the manufacturer.
Test in accordance with 7.1.
5.3 Water and wastewater systems
5.3.1 Incoming water
Instructions for use and technical description shall specify the requirements for the incoming water
either to be supplied to the mobile dental unit or for the bottled water to be used in the mobile dental
unit, or both, including the following parameters:
a) water pressure limits, if applicable;
b) water flow rate limit, if applicable;
c) water hardness limit;
d) pH limits;
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e) maximum particle size;
NOTE The following ranges are typical ranges:
a) water pressure limits (2 bar to 6 bar);
b) water flow rate limit (greater than 5 l/min);
c) water hardness limit [less than 2,14 mmol/l (<12 °dH)];
d) pH limits (6,5 to 8,5);
e) maximum particle size (<100 µm);
Test in accordance with 7.1.
5.3.2 Materials used for construction of procedural water systems within the mobile dental
unit
The requirements specified in 5.3.3 of ISO 7494-2:20XX applies by replacing stationary dental unit with
mobile dental unit.
Test in accordance with 7.1.
5.3.3 Backflow prevention device for mobile dental units connected to the external drinking
water supply
The requirements specified in 5.3.4 of ISO 7494-2:20XX applies by replacing stationary dental unit with
mobile dental unit.
Test in accordance with 7.3.
5.3.4 Cuspidors
If the mobile dental unit provides a cuspidor, the requirements specified in 5.3.5 of ISO 7494-2:20XX
applies.
Test in accordance with 7.4.
5.3.5 Water venturi
If the mobile dental unit provides water venturi for suction of saliva and wastewater, the requirements
specified in 5.3.6 of ISO 7494-2:20XX applies.
Test in accordance with 7.1.
5.3.6 Particle filter
The requirements specified in 5.3.7 of ISO 7494-2:20XX applies by replacing stationary dental unit with
mobile dental unit.
Test in accordance with 7.5.
5.3.7 Bacterial filter
The requirements specified in 5.3.8 of ISO 7494-2:20XX applies by replacing stationary dental unit with
mobile dental unit.
Test in accordance with 7.1.
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5.3.8 Bottled water system supplying procedural water or solution
If the mobile dental unit uses bottled water system, the requirements specified in 5.3.9 of ISO 7494-
2:20XX applies.
Test in accordance with 7.1.
5.3.9 Retraction
The requirements specified in 5.3.10 of ISO 7494-2:20XX applies.
Test in accordance with 7.6.
5.3.10 Treatment method for biofilm
The requirements specified in 5.3.11 of ISO 7494-2:20XX applies by replacing stationary dental unit
with mobile dental unit.
Test in accordance with 7.1.
5.3.11 Water sampling connection point
The requirements specified in 5.3.12 of ISO 7494-2:20XX applies by replacing stationary dental unit
with mobile dental unit.
Test in accordance with 7.1.
5.3.12 Wastewater drain connection
If the mobile dental unit connects to an external wastewater line, the technical description shall specify
the maximum wastewater flow rate from the mobile dental unit that the drain shall be capable of
accommodating.
The technical description shall specify the minimum gradient of the wastewater lines, if applicable.
Test in accordance with 7.1.
5.4 Air system
5.4.1 Incoming dental air
If the mobile dental unit uses an external compressor, the requirements specified in 5.4.2 of ISO 7494-
2:20XX applies by replacing stationary dental unit with mobile dental unit.
Test in accordance with 7.1 and shall conform to ISO 8573-1.
5.4.2 Particle filters
A filter with an effective mesh size not exceeding 50 μm shall be installed at the incoming dental air
connection point of the mobile dental unit or at the connection point to the internal air compressor.
Test in accordance with 7.5.
5.4.3 Bacterial filters
If the mobile dental unit air supply is equipped with a filter intended to restrict the passage of bacteria,
the requirements specified in 5.4.4 of ISO 7494-2:20XX applies by replacing stationary dental unit with
mobile dental unit.
Test in accordance with 7.1.
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5.4.4 Condensate drain
The mobile dental unit shall equip a means to drain off a condensate water, if necessary.
Test in accordance with 7.1.
5.4.5 Compressed air filter
If an air dryer is installed to the mobile dental unit, the grade of filtration for dryer system shall
be ≤ 5 μm.
Test in accordance with 7.1.
5.5 Mobile dental unit suction systems
5.5.1 Maximum suction pressure
If the mobile dental unit uses an external suction machine, the requirements specified in 5.5.2 of
ISO 7494-2:20XX applies by replacing stationary dental unit with mobile dental unit.
Test in accordance with 7.7.1.
5.5.2 Suction pressure head loss
If the mobile dental unit uses an external suction machine, the requirements specified in 5.5.3 of
ISO 7494-2:20XX applies by replacing stationary dental unit with mobile dental unit.
Test in accordance with 7.7.2.
5.5.3 Configuration of cannula connectors and cannula
The requirements, figure and table specified in 5.5.4 of ISO 7494-2:20XX applies by replacing stationary
dental unit with mobile dental unit.
Test in accordance with 7.1.
5.5.4 Operating hoses with cannula connectors
The requirements specified in 5.5.5 of ISO 7494-2:20XX applies.
Test in accordance with 7.1.
5.5.5 Solids filter
The requirements specified in 5.5.6 of ISO 7494-2:20XX applies by replacing stationary dental unit with
mobile dental unit.
Test in accordance with 7.1.
5.5.6 Air separator
The instructions for use and technical description shall include information about maintenance and
replacement of the air separator, if applicable.
Test in accordance with 7.1.
5.5.7 Mobile dental unit suction source connection point
The technical description shall include the connection dimensions, if applicable.
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Test in accordance with 7.1.
5.5.8 Suction flow rate
If the mobile dental unit provides an internal suction machine, the flow rate at the cannula connector
of the mobile dental unit shall not be less than type 1: 250 Nl/min, type 2: 170 Nl/min or type 3: 90 Nl/
min.
Test in accordance with 7.8.
5.5.9 Bacterial filter
If the mobile dental unit includes a bacterial filter, the bacterial filter shall be rated to restrict the
passage of contaminants larger than 0,3 μm and have an efficiency of at least 99,95 %. The mobile
dental unit manufacturer shall provide maintenance instructions and schedule for the bacterial filter.
Test in accordance with 7.1.
5.6 Test report
A test report shall be prepared to report the results of all applicable testing and inspection requirements
specified in this document. Annex A gives a template for the test report.
6 Sampling
One representative sample of the mobile dental unit water and air supply and mobile dental unit suction
systems being tested shall be selected.
7 Measurement and test methods
7.1 Visual inspection
7.1.1 Visual inspection of equipment
Visually inspect the equipment to determine compliance with the requirements.
7.1.2 Visual inspection of documentation or test reports
Visually inspect product documentation or test reports to determine conformity with the requirements.
7.2 Dental handpiece connection test
7.2.1 Apparatus
The test apparatus shall include the following as depicted in Figure 3 and Figure 4:
7.2.1.1 Volumetric measuring jar, with an accuracy of ± 5 %, to measure water flow rate.
7.2.1.2 Flowmeter, with an accuracy of ± 5 %, to measure water flow air flow rate.
7.2.1.3 Pressure gauge, with an accuracy of ± 5 %, to measure the air or water supply pressure.
7.2.1.4 Adapter, with a hose connection Type 3 according to ISO 9168 on both sides to be fitted
between hose and e.g. a turbine.
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7.2.1.5 Dental handpiece connection jig, as depicted in Fig
...
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