Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 5467-2:2022)

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.

Zahnheilkunde - Mobile dentale Behandlungseinheiten und dentale 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

Status
Published
Publication Date
30-Jan-2023
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
12-Oct-2022
Due Date
07-Apr-2024
Completion Date
12-Oct-2022

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 5467-2:2023
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 5467-2:2023
EN ISO 5467-2:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 5467-2:2023
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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
© 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
---------------------- Page: 9 ----------------------
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

© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
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.
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
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.
© 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
---------------------- Page: 2 ----------------------
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
© 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
---------------------- Page: 5 ----------------------
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

© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
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.
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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.
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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.
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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
— IEC Electropedia: available at https:// www .electropedia .org/
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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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
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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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
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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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
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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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
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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oSIST prEN ISO 5467-2:2022
ISO/DIS 5467-2:2021(E)
7.2.1.5 Dental handpiece connection jig, as depicted in Fig
...

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