SIST EN ISO 10637:2001

SLOVENSKI STANDARD
SIST EN ISO 10637:2001
01-november-2001
Dental equipment - High- and medium-volume suction systems (ISO 10637:1999)
Dental equipment - High- and medium-volume suction systems (ISO 10637:1999)
Zahnärztliche Ausrüstungen - Absaugsysteme mit hoher und mittlerer Durchflußmenge
(ISO 10637:1999)
Matériel dentaire - Systemes d'aspiration a haut et moyen volume (ISO 10637:1999)
Ta slovenski standard je istoveten z: EN ISO 10637:2000
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 10637:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10637:2001

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SIST EN ISO 10637:2001

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SIST EN ISO 10637:2001

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SIST EN ISO 10637:2001

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SIST EN ISO 10637:2001

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SIST EN ISO 10637:2001
INTERNATIONAL ISO
STANDARD 10637
First edition
1999-08-01
Dental equipment — High- and medium-
volume suction systems
Matériel dentaire — Systèmes d'aspiration à haut et moyen volume
A
Reference number
ISO 10637:1999(E)

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SIST EN ISO 10637:2001
ISO 10637:1999(E)
Page
Contents
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Classification.4
5 Requirements.5
6 Sampling.10
7 Test procedures.10
8 Information to be supplied by the manufacturer.14
9 Marking .15
10 Packaging.16
Annex A (normative) Sequence of testing.17
©  ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
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SIST EN ISO 10637:2001
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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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard ISO 10637 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 6, Dental equipment.
Annex A forms a normative part of this International Standard.
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Introduction
This International Standard contains specifications for high- and medium-volume suction systems which are used in
the dental surgery as part of the dental equipment.
The aim of this International Standard is to ensure the reliable function of suction systems and the necessary safety
in common usage and within normal ambient conditions.
Any item of dental equipment recommended by the manufacturer for use in connection with suction systems should
not render the equipment unsafe.
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SIST EN ISO 10637:2001
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INTERNATIONAL STANDARD  ISO ISO 10637:1999(E)
Dental equipment —
High- and medium-volume suction systems
1 Scope
This International Standard applies to high- and medium-volume suction systems which are items of dental
equipment. They are usually an integral part of a dental unit.
This International Standard specifies performance and safety requirements as well as test procedures for high- and
medium-volume suction systems. It also contains specifications on manufacturer's instructions, marking and
packaging.
This International Standard takes priority, where applicable, over IEC 60601-1, as specified in the individual clauses
of this International Standard.
This International Standard is not applicable to low-volume suction systems.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 1942-4, Dental vocabulary — Part 4: Dental equipment.
ISO 7494, Dental units.
lSO 9687, Dental equipment — Graphical symbols.
IEC 60335-1, Safety of household and similar electrical appliances — Part 1: General requirements.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
IEC 60651, Sound level metres.
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SIST EN ISO 10637:2001
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3 Terms and definitions
For the purposes of this lnternational Standard, the terms and definitions given in lEC 60601-1:1988, clause 2, and
the following apply.
3.1
suction system
active entity of dental equipment, including a suction machine, which enables 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
See Figure 1.
NOTE It is a combination of apparatus and accessories. Some components are described in 3.2 to 3.7.
3.2
suction device
passive entity which can only induce an air flow when connected to a suction machine
3.3
air separator
apparatus which separates liquids and solids from the suction air
3.4
filter
apparatus which retains solids from the air and liquids passing through it
3.5
central system
vacuum system having at least one suction machine which serves more than one device
3.6
accessories
cannula, manifold, filter and/or mobile support
3.7
cannula connector
cartridge, at the end of the hose part of the suction system, intended for fitting of cannulae and for placement in the
mobile support
NOTE Also called a suction handpiece.
3.8
low-volume suction system
suction system with an air intake of less than 90 l/min
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Figure 1 — Suction systems
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4 Classification
4.1 According to the air volume flowrate provided
Suction systems to which this International Standard is applicable are classified according to the air volume flowrate
provided as follows:
a) High-volume suction system
Suction system with an air intake of more than 250 litres per minute (l/min) in each suction device.
b) Medium-volume suction system
Suction system with an air intake between 90 l/min and 250 l/min in each suction device.
4.2 According to the type of suction
Suction systems are classified according to the type of suction as follows:
a) Dry system
Suction system in which, with an air separator, liquids and solids have been removed from the air flow before
the air enters the suction machine and in which the separator and the suction machine are two different
devices. See Figure 1.
b) Semi-dry system
Suction system in which, with an air separator, liquids and solids have been removed from the air flow before
the air enters the suction machine and in which the separator and the suction machine are combined into one
device. See Figure 1.
c) Wet system
Suction system in which solids have been removed from the air flow by a filter before air and liquid enter the
suction machine, where they in turn are separated. See Figure 1.
4.3 According to the type of protection against electric shock (see IEC 60601-1)
Suction systems are classified according to the type of protection against electric shock by classes as follows:
a) Class I equipment
Equipment in which protection against electric shock does not rely on basic insulation only, but includes an
additional safety precaution which provides means for the connection of accessible conductive parts to the
protective (earth) conductor in the fixed wiring of the installation such that accessible conductive parts cannot
become live in the event of a failure of the basic insulation.
b) Class II equipment
Equipment in which protection against electric shock does not rely on basic insulation only, but in which
additional safety precautions such as double insulation or reinforced insulation are provided, there being no
provision for protective earthing or reliance upon installation conditions.
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4.4 According to the degree of protection against electric shock (see IEC 60601-1)
Suction systems are classified according to the degree of protection against electric shock by type as follows:
a) Type B equipment (see IEC 60601-1:1988, 2.2.24)
Class I or II equipment or equipment with an internal electrical power source providing an adequate degree of
protection against electric shock, particularly regarding:
 allowable leakage current;
 reliability of the protective earth connection, if present.
NOTE Type B equipment is, for example, suitable for intentional external and internal application to the patient,
excluding direct cardiac application.
b) Type BF equipment (see IEC 60601-1:1988, 2.2.25)
Type B equipment with an F-type isolated (floated) applied part.
4.5 According to the mode of operation (see IEC 60601-1:1988, 2.10)
Suction systems are classified as applicable for either intermittent or continuous operation.
5 Requirements
5.1 General
This clause contains requirements relevant to high- and medium-volume suction systems. Many of these
requirements are quantitatively verifiable as detailed in clause 7.
Some requirements are objectively verifiable by visual inspection.
Compliance with some requirements, however, involves a subjective decision of qualified testing personnel. It is
envisaged to include in these cases quantitative tests as soon as results of relevant research work are available.
Electrical requirements are only applicable to electrically powered high- and medium-volume suction systems and
high- and medium volume suction devices intended for use in powered suction systems. However, the general
requirements in IEC 60601-1 which are referred to are applicable to nonelectrical suction systems and devices as
well.
5.2 General requirements
5.2.1 Design
5.2.1.1  High- and medium-volume suction systems shall be designed, constructed and manufactured so that when
properly transported, stored, installed, used and maintained according to the manufacturer’s instructions, they
cause no danger which could reasonably be foreseen to the patient, to the operating personnel, or to the
surroundings in normal use and in single fault condition.
These requirements cannot be objectively assessed. They are considered as fulfilled if all of the applicable
requirements of clause 5 are fulfilled.
5.2.1.2  High- and medium-volume suction systems shall have the strength and rigidity necessary to resist the
stresses to which they may be subjected in normal dental practice without risk of introducing fire, electrical shock, or
accident hazard.
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These requirements cannot be objectively assessed. They are considered as fulfilled if all of the applicable
requirements of clause 5 are fulfilled.
5.2.1.3  Dry systems shall include a suction machine, an air separator, a suction pipeline and appropriate
accessories.
5.2.1.4  Semi-dry systems shall include a suction machine with an air separator before the suction machine, an
interconnecting pipeline and appropriate accessories.
5.2.1.5  Wet systems shall include a suction machine, an interconnecting pipeline and appropriate accessories.
5.2.1.6  Edges and corners of components and parts accessible to the patient or dental personnel shall be finished
so as to avoid injury to the patient or the dental personnel. Compliance shall be checked by visual inspection.
5.2.1.7  For suction machines, the requirements of lEC 60335-1 apply.
5.2.2 Cleaning and disinfection
All exterior parts shall be cleanable and disinfectable, without deteriorating the surface or markings, by using agents
recommended by the manufacturer of the suction system.
Testing shall be carried out in accordance with 7.2.
All interior parts should be cleanable and disinfectable, without deteriorating the surface or markings, by using agents
recommended by the manufacturer of the suction system.
5.3 Performance requirements
5.3.1 High-volume suction systems
5.3.1.1 High-volume suction systems with integral suction machine
The suction system shall ensure an air suction volume flowrate of at least 250 l/min into the cannula connector of
the largest-bore operating hose, when operated at full power and in accordance with the manufacturer’s instruction
for use.
The maximum vacuum at the cannula connector shall not exceed 25 kPa under worst case normal operating
conditions, including zero-suction volume into all available cannulae.
An agreement between the parties concerned should specify the number of suction devices intended to be
connected and the number of these dental units to be open when the flowrate is tested.
Testing shall be carried out in accordance with 7.3.1.2
5.3.1.2 High-volume suction systems for single surgery use and with separate suction machine
The suction system shall ensure an air suction volume flowrate of at least 250 l/min into the cannula connector of
the largest-bore operating hose, when operated at full power and in accordance with the manufacturer’s instruction
for use and when the suction device is connected to the suction machine through a pipeline of the smallest diameter
and maximum length recommended by the manufacturer.
The maximum vacuum at the cannula connector shall not exceed 25 kPa under worst-case normal operating
conditions, including a zero-suction volume by closed-cannulae connector.
Testing shall be carried out in accordance with 7.3.1.3
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5.3.1.3 High-volume suction systems with central suction machine
The suction system shall ensure an air suction volume flowrate of at least 250 l/min into the cannula connector of
the largest-bore operating hose, when operated at full power and in accordance with the manufacturer’s instruction
for use.
The maximum vacuum at the cannula connector of any operating hose shall not exceed 25 kPa under worst-case
normal operating conditions, including a zero-suction volume by closed-cannulae connector.
Testing shall be carried out in accordance with 7.3.1.4.
5.3.1.4 High-volume suction device with vacuum specified by the manufacturer
The suction device shall admit an air suction volume flowrate of at least 250 l/min into the cannula connector of the
largest-bore operating hose when the vacuum specified by the manufacturer is applied and maintained at the
connection part and the suction device is operated according to the manufacturer’s instructions for normal use.
The maximum vacuum at the cannula connector shall not exceed 25 kPa under worst-case normal operating
connections, including a zero-suction volume by closed-cannulae connector.
Testing shall be carried out in accordance with 7.3.1.5
5.3.2 Medium-volume suction systems
The medium-volume suction system shall ensure an air suction volume flowrate of at least 90 l/min at the cannula
connection without cannulae.
The maximum vacuum at the cannula connector shall not exceed 25 kPa under worst-case normal operating
conditions, including a zero-suction volume by closed-cannulae connector.
In case of central suction systems, these requirements shall be ensured at each connection when all connected
devices are functioning.
An agreement between the parties concerned should specify the number of dental units intended to be connected
and the number of these dental units to be open when the flowrate is tested.
Testing shall be carried out in accordance with the appropriate subclauses of 7.3.1.
5.4 Air separators
Air separators should require minimal and easy maintenance.
5.5 Requirements for accessories
5.5.1 Cannula connectors
Cannula connectors for high-volume suction systems shall have a nominal inside diameter of (15 ± 1) mm or
(11 ± 1) mm at the narrowest dimension. The dimensions for the fittings are given by the manufacturer.
Cannula connectors for medium-volume suction systems shall have a nominal inside diameter of at least 9 mm at
the narrowest dimension.
Compliance shall be verified using readily available measuring instruments.
Cannula conectors should allow easy access of the cannula to every part of the patient's mouth without causing
distortion of the hoses.
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5.5.2 Operating hoses
Operating hoses should be internally smooth, flexible and noncollapsible. Operating hoses shall withstand a
vacuum of 25 kPa. They should be cleanable, disinfectable and easy to handle for hygenic treatment by methods
and with agents recommended by the manufacturer of the suction systems.
Compliance shall be verified by v
...