EN ISO 10637:2018

Dentistry - Central suction source equipment (ISO 10637:2018)

This document specifies requirements and test methods for stationary, electrically powered central suction source equipment, including centrally located amalgam separators and air water separators.
It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central suction source equipment as part of the complete dental suction system.
This document specifies requirements for central suction source equipment used to provide vacuum pressure and flow at the facility pipeline connection point.
This document does not apply to portable suction source equipment, air/water venturi suction source equipment, or to suction source equipment located in the treatment room. It also does not apply to suction source equipment used for life support or for scavenging halogenated anaesthetic gases.
This document does not include requirements for facility and exhaust piping systems or treatment room equipment.

Zahnheilkunde - Zentrale Absauganlage (ISO 10637:2018)

In diesem Dokument werden die Anforderungen und Prüfverfahren für stationäre, elektrisch betriebene zentrale Absauganlagen, einschließlich zentraler Amalgamabscheider und Wasser-/Luftseparatoren, festgelegt.
Außerdem werden Anforderungen an die Herstellerangaben über Leistung, Installation, Betrieb und Wartung der zentralen Absauganlage als Teil eines vollständigen dentalen Absaugsystems festgelegt.
In diesem Dokument werden Anforderungen für zentrale Absaugmaschinen festgelegt, die Unterdruck und einen Durchfluss am Anschlusspunkt der Platzabsaugleitung erzeugen.
Dieses Dokument gilt nicht für mobile Absauganlangen, Absaugmaschinen mit einer Luft-/Wasserstrahl-pumpe oder für Absaugmaschinen, die sich im Behandlungsraum befinden. Es gilt außerdem nicht für Absaugmaschinen, die zur Lebensunterstützung oder zum Absaugen halogenierter Anästhesiegase verwendet werden.
Dieses Dokument enthält keine Anforderungen an die Rohrleitungssyteme für Luftzuführung und Abluft oder für die Ausrüstung des Behandlungsraums.

Médecine bucco-dentaire - Systèmes d'aspiration centrale (ISO 10637:2018)

Le présent document spécifie les exigences et les méthodes d'essai applicables à une source d'aspiration centrale électrique fixe, notamment les séparateurs d'amalgames centraux et les séparateurs air/eau.
Il spécifie également les exigences relatives aux informations à fournir par le fabricant sur la performance, l'installation, le fonctionnement et l'entretien de la source d'aspiration centrale composant le système d'aspiration dentaire complet.
Le présent document spécifie les exigences relatives à la source d'aspiration centrale utilisée pour générer une pression à vide et un débit au niveau du point de raccordement de la conduite de l'installation.
Il ne s'applique pas à une source d'aspiration portable, à une source d'aspiration avec venturi à air/eau ou à une source d'aspiration située dans la salle de traitement. Il ne s'applique pas non plus à une source d'aspiration utilisée pour le maintien artificiel des fonctions vitales ou pour l'évacuation des gaz anesthésiques halogénés.
Le présent document ne comprend aucune exigence relative aux conduites de l'installation et d'évacuation ou au matériel de la salle de traitement.

Zobozdravstvo - Centralna sukcijska (aspiracijska) oprema (ISO 10637:2018)

Ta dokument določa zahteve in preskusne metode za stacionarno električno stacionarno centralno sukcijsko (aspiracijsko) opremo, vključno s centralno nameščenimi ločevalniki amalgama ter ločevalniki vode/zraka. Določa tudi zahteve glede informacij, ki jih mora zagotoviti proizvajalec o delovanju, namestitvi, upravljanju n vzdrževanju centralne sukcijske (aspiracijske) opreme v okviru celotnega zobozdravstvenega sukcijskega sistema.
Ta dokument določa zahteve za centralno sukcijsko (aspiracijsko) opremo, ki se uporablja za zagotavljanje tlak in pretok vakuuma na priključku cevovoda v ustanovi.
Ta dokument se ne uporablja za prenosno sukcijsko (aspiracijsko) opremo, venturijevo sukcijsko opremo zrak/voda ali sukcijsko (aspiracijsko) opremo, nameščeno v ambulanti. Prav tako se ne uporablja za sukcijsko (aspiracijsko) opremo, ki se uporablja za ohranjanje življenja ali za splakovanje halogeniranih anestezijskih plinov. Ta dokument ne vključuje zahtev za objekt in izpušne cevne sisteme ali opremo v ambulanti.

General Information

• Status: Withdrawn
• Publication Date: 29-Sep-2018
• Withdrawal Date: 30-Dec-2018
• 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: 13-Jun-2018
• Completion Date: 13-Jun-2018
• Ref Project: SIST EN ISO 10637:2018 - Dentistry - Central suction source equipment (ISO 10637:2018)

Relations

• Replaces: EN ISO 10637:2000 - Dental equipment - High- and medium-volume suction systems (ISO 10637:1999)
• Effective Date: 20-Jun-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10637:2018
01-september-2018
1DGRPHãþD
SIST EN ISO 10637:2001
Zobozdravstvo - Centralna sukcijska (aspiracijska) oprema (ISO 10637:2018)
Dentistry - Central suction source equipment (ISO 10637:2018)
Zahnheilkunde - Zentrale Absauganlage (ISO 10637:2018)
Médecine bucco-dentaire - Systèmes d'aspiration centrale (ISO 10637:2018)
Ta slovenski standard je istoveten z: EN ISO 10637:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 10637:2018 en

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

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SIST EN ISO 10637:2018
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SIST EN ISO 10637:2018
EN ISO 10637
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2018
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 10637:2000
English Version
Dentistry - Central suction source equipment (ISO
10637:2018)

Médecine bucco-dentaire - Systèmes d'aspiration Zahnheilkunde - Zentrale Absauganlage (ISO

centrale (ISO 10637:2018) 10637:2018)
This European Standard was approved by CEN on 9 March 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10637:2018 E

worldwide for CEN national Members.
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SIST EN ISO 10637:2018
EN ISO 10637:2018 (E)
Contents Page

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

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SIST EN ISO 10637:2018
EN ISO 10637:2018 (E)
European foreword

This document (EN ISO 10637:2018) 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 December 2018, and conflicting national standards

shall be withdrawn at the latest by December 2018.

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.

This document supersedes EN ISO 10637:2000.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 10637:2018 has been approved by CEN as EN ISO 10637:2018 without any modification.

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SIST EN ISO 10637:2018
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SIST EN ISO 10637:2018
INTERNATIONAL ISO
STANDARD 10637
Second edition
2018-05
Dentistry — Central suction source
equipment
Médecine bucco-dentaire — Systèmes d'aspiration centrale
Reference number
ISO 10637:2018(E)
ISO 2018
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SIST EN ISO 10637:2018
ISO 10637:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 10637:2018
ISO 10637:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Classification ............................................................................................................................................................................................................ 3

4.1 Classification according to separation of solids and liquids from air flow ......................................... 3

4.2 Classification according to air flow rate ............................................................................................................................ 3

5 Requirements .......................................................................................................................................................................................................... 4

5.1 Characterization of central suction source equipment flow rate performance .............................. 4

5.2 Maximum suction pressure .......................................................................................................................................................... 4

5.3 Safety requirements ........................................................................................................................................................................... 4

5.4 Electromagnetic compatibility (EMC)................................................................................................................................. 4

5.5 Other requirements as applicable .......................................................................................................................................... 4

5.5.1 Amalgam separator ....................................................................................................................................................... 4

5.5.2 Bacterial filter ..................................................................................................................................................................... 5

6 Sampling ........................................................................................................................................................................................................................ 5

7 Measurement and test methods ........................................................................................................................................................... 5

7.1 General ........................................................................................................................................................................................................... 5

7.1.1 General provisions for tests.................................................................................................................................... 5

7.1.2 Reference conditions (air flow rates) ............................................................................................................ 5

7.1.3 Atmospheric conditions ............................................................................................................................................ 5

7.1.4 Other conditions............................................................................................................................................................... 5

7.2 Performance tests ................................................................................................................................................................................. 6

7.2.1 Measurement of flow rate performance ...................................................................................................... 6

7.2.2 Measurement of maximum suction pressure ......................................................................................... 6

7.2.3 Measures to prevent excessive static suction at the facility suction

pipeline connection point ........................................................................................................................................ 6

7.3 Bacterial filters ........................................................................................................................................................................................ 6

7.4 Visual inspection ................................................................................................................................................................................... 6

7.4.1 Visual inspection equipment ................................................................................................................................. 6

7.4.2 Visual inspection of documentation ............................................................................................................... 6

8 Information supplied by the manufacturer ............................................................................................................................. 7

8.1 General ........................................................................................................................................................................................................... 7

8.2 Instructions for use ............................................................................................................................................................................. 7

8.3 Technical description ........................................................................................................................................................................ 7

9 Marking .......................................................................................................................................................................................................................... 8

9.1 Marking on outside of electrically operated central suction source equipment ............................ 8

9.2 Exhaust pipeline connection point ........................................................................................................................................ 8

10 Packaging ..................................................................................................................................................................................................................... 8

Annex A (informative) Types of suction systems ..................................................................................................................................10

Annex B (informative) Dry-suction system source equipment diagram ......................................................................12

Annex C (informative) Semi-dry-suction system source equipment diagram .......................................................13

Annex D (informative) Wet suction system source equipment diagram......................................................................15

Bibliography .............................................................................................................................................................................................................................17

© ISO 2018 – All rights reserved iii
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SIST EN ISO 10637:2018
ISO 10637:2018(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the 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 the following

URL: www .iso .org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental

equipment.

This second edition cancels and replaces the first edition (ISO 10637:1999), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— clarification of the scope;

— addition of the classification according to the air flow rate (Type 1, Type 2 or Type 3);

— addition of measurement and test methods;
— addition of diagrams for different suction source equipment in the Annexes.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 10637:2018
ISO 10637:2018(E)
Introduction

Dental suction systems evacuate solids, liquids, aerosols and gases from the oral cavity and immediate

surrounding area for the purpose of improving operating effectiveness and efficiency during oral

treatment procedures and limiting the contamination of the immediate environment. In central suction

systems the equipment that generates suction and performs other supporting functions is located in

a central location outside of the dental treatment room to isolate this equipment from the immediate

vicinity of patient treatment and often to provide suction to multiple treatment rooms.

A central suction system consists of four basic elements:
1) dental treatment room suction components (e.g. dental unit suction system);
2) facility suction pipeline;
3) central suction source equipment;
4) exhaust pipeline.

The central suction source equipment consists of all the components from the facility suction pipeline

connection point (i.e. discharge end of the facility suction pipeline) to the exhaust pipeline connection

point (i.e. inlet to the exhaust pipeline). In addition to the equipment that generates air flow, centrally

located amalgam separators and air water separators (if present) are also component parts of the

central suction source equipment.
© ISO 2018 – All rights reserved v
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SIST EN ISO 10637:2018
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SIST EN ISO 10637:2018
INTERNATIONAL STANDARD ISO 10637:2018(E)
Dentistry — Central suction source equipment
1 Scope

This document specifies requirements and test methods for stationary, electrically powered central

suction source equipment, including centrally located amalgam separators and air water separators.

It also specifies requirements for information to be supplied by the manufacturer on the performance,

installation, operation and maintenance of the central suction source equipment as part of the complete

dental suction system.

This document specifies requirements for central suction source equipment used to provide vacuum

pressure and flow at the facility pipeline connection point.

This document does not apply to portable suction source equipment, air/water venturi suction source

equipment, or to suction source equipment located in the treatment room. It also does not apply to

suction source equipment used for life support or for scavenging halogenated anaesthetic gases.

This document does not include requirements for facility and exhaust piping systems or treatment

room equipment.
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 7010:2011, Graphical symbols — Safety colours and safety signs — Registered safety signs

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

ISO 9687, Dentistry — Graphical symbols for dental equipment
ISO 11143, Dentistry — Amalgam separators

ISO 29463-1:2017, High efficiency filters and filter media for removing particles from air — Part 1:

Classification, performance, testing and marking

IEC 60335-1, Household and similar electrical appliances — Safety — Part 1: General requirements

IEC 61000-6-2, Electromagnetic compatibility (EMC) — Part 6-2: Generic standards — Immunity standard

for industrial environments

IEC 61000-6-3, Electromagnetic compatibility (EMC) — Part 6-3: Generic standards — Emission standard

for residential, commercial and light-industrial environments
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942, ISO 7494-2 and the

following apply.
© ISO 2018 – All rights reserved 1
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SIST EN ISO 10637:2018
ISO 10637:2018(E)

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http: //www .electropedia .org
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
air separator

apparatus which separates liquids and solids from the suction system air flow (3.11)

3.2
cannula connector

component at the inlet end of the dental suction operating hose, which joins the cannula to the

opera
...