EN 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 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: 11-Oct-2022
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Oct-2022
• Due Date: 07-Apr-2024
• Completion Date: 12-Oct-2022
• Ref Project: SIST EN ISO 5467-2:2023 - Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 5467-2:2022)

Overview

EN ISO 5467-2:2022 - "Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems" specifies requirements and test methods for the fluid and suction systems of mobile dental units. It covers connections to facility supplies (compressed air, water, suction, wastewater), internal system materials and design, incoming water and air quality, suction performance, and interfaces to dental handpieces. The standard excludes amalgam separators and mobile units intended for oral surgery that require sterile air/water.

Key topics and technical requirements

• Connections and interfaces
  • Requirements for mobile dental unit connections to compressed air, water, suction and wastewater drain plumbing.
  • Properties of connections to dental handpieces (air, water, suction, wastewater).
• Water systems
  • Materials, design and construction of internal compressed air and procedural water systems.
  • Incoming potable water quality and provisions for bottled water supplies used for procedural water.
  • Backflow prevention when connected to external drinking water supply.
  • Cuspidor, water venturi, particle and bacterial filter provisions; water sampling connection point; wastewater container and drain connections.
  • Requirements for biofilm control and retraction prevention.
• Air systems
  • Classification and purity class of dental air, including requirements for integrated compressed air source equipment.
  • Particle and bacterial filters, condensate drain, compressed air filtration and acceptable sound levels.
• Suction systems
  • Suction source connection, maximum suction pressure, suction pressure head loss, suction flow rate, solids filters and air separators.
  • Cannula connector configuration and hose requirements.
• Testing, documentation and labelling
  • Test methods such as particle filter testing, suction flow rate testing, visual inspection, sampling and reporting.
  • Requirements for instructions for use, technical description and test reports.

Practical applications

• Ensures safe, reliable fluid and suction performance of mobile dental units used in clinics, outreach programs, mobile clinics and temporary treatment sites.
• Guides design and manufacture of mobile dental units and dental patient chairs to meet EU/CEN and ISO expectations for air, water, suction and wastewater systems.
• Supports service technicians and maintenance teams with test methods for filters, suction flow rates and system inspection.
• Helps infection control teams assess incoming water/air quality, filtration and biofilm control measures.

Who should use this standard

• Dental equipment manufacturers and designers
• Regulatory bodies and conformity assessment organizations
• Dental clinics and mobile clinic operators
• Service/maintenance technicians and biomedical engineers
• Procurement and quality managers specifying mobile dental units

Related standards

• ISO 5467 series (other parts)
• ISO 7494-2:2022 (relevant for dental air supply classification; referenced in the development of this part)

Keywords: EN ISO 5467-2:2022, mobile dental units, dental patient chairs, air water suction wastewater systems, dental air quality, backflow prevention, suction flow rate, particle filter, bacterial filter.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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 5467-2:2022(E)
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
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 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 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 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
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
...