EN ISO 7494-2:2015

Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)

ISO 7494-2:2015 specifies requirements and test methods concerning
a)    the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b)    the materials, design, and construction of the compressed air and water system within the dental unit,
c)    the quality for incoming water and air, and
d)    the performance of dental unit suction system.
ISO 7494-2:2015 also specifies requirements for instructions for use and technical description.
ISO 7494-2:2015 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in ISO 7494-2:2015.

Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil 2: Luft-, Wasser-, Absaugungs- und Abwassersysteme (ISO 7494-2:2015)

Dieser Teil von ISO 7494 legt Anforderungen an und Prüfverfahren für Folgendes fest:
a) Die Konfiguration der Anschlüsse der zahnärztlichen Behandlungseinheit für Druckluftzufuhr, Wasserversorgung, Absaugung und Entleerung der Abwasserrohrleitungen.
b) Die Materialien, Gestaltung und Bauweise der Druckluftzufuhr und Wasserversorgung innerhalb der zahnärztlichen Behandlungseinheit.
c) Die Qualität des einströmenden Wassers und der einströmenden Luft.
d) Die Leistungsfähigkeit der Absaugeinrichtungen in der zahnärztlichen Behandlungseinheit.
Dieser Teil von ISO 7494 legt auch Anforderungen an die vom Hersteller bereitzustellende Gebrauchs-anweisung, Kennzeichnung, Verpackung und technische Beschreibung fest.
Dieser Teil von ISO 7494 ist auf zahnärztliche Behandlungseinheiten beschränkt, die nicht für die lebens-erhaltende Behandlung stationärer Patienten oder für die kieferchirurgische Behandlung verwendet werden, für die eine Versorgung mit steriler Luft und sterilem Wasser erforderlich ist. Amalgamabscheider sind in dieser Norm nicht enthalten.

Médecine bucco-dentaire - Units dentaires - Partie 2: Systèmes d'alimentation en air et en eau, d'aspiration et d'évacuation des eaux usées (ISO 7494-2:2015)

L'ISO 7494-2:2015 spécifie les exigences et les méthodes d'essai concernant:
a)    la configuration des branchements de l'unit dentaire aux conduites d'alimentation en air comprimé, d'alimentation en eau, d'aspiration et aux canalisations d'évacuation des eaux usées,
b)    les matériaux, la conception et la construction du système d'alimentation en air comprimé et en eau de l'unit dentaire,
c)    la qualité de l'eau et de l'air d'entrée, et
d)    la performance du système d'aspiration de l'unit dentaire.
L'ISO 7494-2:2015 spécifie également les exigences relatives aux consignes d'utilisation et à la description technique.
L'ISO 7494-2:2015 se limite aux units dentaires qui ne sont pas utilisés pour le traitement essentiel à la survie des patients ambulatoires ou pour le traitement de chirurgie buccale nécessitant une alimentation en air et en eau stérile. Les séparateurs d'amalgames ne sont pas inclus dans l'ISO 7494-2:2015.

Zobozdravstvo - Zobozdravstvene enote - 2. del: Zrak, voda, sukcija (aspiracija) in sistemi odpadnih voda (ISO 7494-2:2015)

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2015
• Withdrawal Date: 18-Oct-2022
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 19-Oct-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 7494-2:2015 - Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)

Relations

• Replaces: EN ISO 11144:1996 - Dental equipment - Connections for supply and waste lines (ISO 11144:1995)
• Effective Date: 03-Nov-2011
• Replaces: EN ISO 7494-2:2003 - Dentistry - Dental units - Part 2: Water and air supply (ISO 7494-2:2003)
• Effective Date: 15-Oct-2011
• Replaced By: EN ISO 7494-2:2022 - Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2022)
• Effective Date: 26-Oct-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2015
1DGRPHãþD
SIST EN ISO 11144:2000
SIST EN ISO 7494-2:2003
Zobozdravstvo - Zobozdravstvene enote - 2. del: Zrak, voda, sukcija (aspiracija) in
sistemi odpadnih voda (ISO 7494-2:2015)
Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-
2:2015)
Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil 2: Luft, Wasser, Absaugung
und Abwassersystem (ISO 7494-2:2015)
Médecine bucco-dentaire - Units dentaires - Partie 2: Systèmes d'alimentation en air et
en eau, d'aspiration et d'évacuation des eaux usées (ISO 7494-2:2015)
Ta slovenski standard je istoveten z: EN ISO 7494-2:2015
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 7494-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2015
ICS 11.060.20 Supersedes EN ISO 11144:1996, EN ISO 7494-2:2003
English Version
Dentistry - Dental units - Part 2: Air, water, suction and
wastewater systems (ISO 7494-2:2015)
Médecine bucco-dentaire - Units dentaires - Partie 2: Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil
Systèmes d'alimentation en air et en eau, d'aspiration et 2: Luft, Wasser, Absaugung und Abwassersystem (ISO
d'évacuation des eaux usées (ISO 7494-2:2015) 7494-2:2015)
This European Standard was approved by CEN on 10 January 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7494-2:2015 E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 7494-2:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in
collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2015, and conflicting national standards shall be withdrawn at
the latest by October 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7494-2:2003 and EN ISO 11144:1996.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7494-2:2015 has been approved by CEN as EN ISO 7494-2:2015 without any modification.
INTERNATIONAL ISO
STANDARD 7494-2
Second edition
2015-04-01
Dentistry — Dental units —
Part 2:
Air, water, suction and wastewater
systems
Médecine bucco-dentaire — Units dentaires —
Partie 2: Systèmes d’alimentation en air et en eau, d’aspiration et
d’évacuation des eaux usées
Reference number
ISO 7494-2:2015(E)
©
ISO 2015
ISO 7494-2:2015(E)
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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ii © ISO 2015 – All rights reserved

ISO 7494-2:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 4
4.1 Classification of suction systems . 4
4.2 Classification of suction air volume flow rate . 4
5 Requirements . 4
5.1 Requirements for supply connections . 4
5.2 Requirements for water and wastewater systems . 4
5.2.1 Incoming water . 5
5.2.2 Materials used for construction of procedural water systems within the
dental unit. 6
5.2.3 Backflow prevention device for dental units connected to the external
drinking water supply . 7
5.2.4 Cuspidors . . 7
5.2.5 Water venturi . 7
5.2.6 Particle filter . 7
5.2.7 Bacterial filter . 7
5.2.8 Bottled water system supplying procedural water or solution . 7
5.2.9 Retraction . 7
5.2.10 Water disinfection systems . 7
5.2.11 Water sampling connection point . 8
5.2.12 Wastewater drain connection. 8
5.3 Requirements for the air system . 8
5.3.1 Incoming air (dental air) . 8
5.3.2 Particle filters . 8
5.3.3 Bacterial filters . 9
5.4 Requirements for dental unit suction systems . 9
5.4.1 Static vacuum pressure . 9
5.4.2 Head loss . 9
5.4.3 Air separators . 9
5.4.4 Cannula connectors and cannula . 9
5.4.5 Operating hoses with cannula connectors .10
5.4.6 Solids filter .11
5.4.7 Noise level .11
5.4.8 Dental unit suction source connection point .11
6 Sampling .11
7 Tests .11
7.1 Cuspidors .11
7.2 Water venturi .11
7.3 Systems directly connected to external drinking water supply .11
7.4 Bottled water system supplying procedural water or solution .11
7.5 Retraction .12
7.6 Particle filters .12
7.7 Bacterial filters .12
7.8 Water disinfection systems .12
7.9 Tests for dent
...