SIST EN ISO 22052:2020
(Main)Dentistry - Central compressed air source equipment (ISO 22052:2020)
Dentistry - Central compressed air source equipment (ISO 22052:2020)
This document applies to central compressed air source equipment for dental compressed air used in dentistry. It specifies functional requirements for compressed air source equipment and quality requirements for the dental compressed air produced by the compressed air source equipment.
This International Standard specifies the purity level of dental compressed air and test procedures for central compressed air source equipment and test procedures for the quality requirements for dental compressed air.
It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the compressed air source equipment.
This International Standard only applies to central compressed air source equipment located outside of the dental treatment room.
Dental compressors located in the dental treatment room and facility piping are excluded from the scope of this International Standard.
Zahnheilkunde - Zentrale Druckluftversorgungsanlage (ISO 22052:2020)
Dieses Dokument legt Anforderungen und Prüfverfahren für zentrale Druckluftversorgungsanlagen fest, die dentale Behandlungseinheiten und verschiedene, dentale Luft verbrauchende Geräte in der Zahnarztpraxis mit dentaler Luft versorgen.
Außerdem legt es Qualitätsanforderungen und Prüfverfahren für die dentale Luft, die von der zentralen Druckluftversorgungsanlage erzeugt wird, wie Anforderungen an den Reinheitsgrad der dentalen Luft, fest.
Außerdem werden Anforderungen an die Herstellerangaben über Leistung, Installation, Betrieb und Wartung der zentralen Druckluftversorgungsanlage festgelegt.
Dieses Dokument gilt nur für zentrale Druckluftversorgungsanlagen, die sich außerhalb des dentalen Behandlungsraums befinden.
Dieses Dokument gilt nicht für zentrale Druckluftversorgungsanlagen, die sich im dentalen Behandlungsraum befinden, sowie für die Rohrleitungssysteme der Anlagen. Dieses Dokument enthält keine Anforderungen an Anwendungen im zahntechnischen Labor (z. B. CAD /CAM Systeme).
Médecine bucco-dentaire - Centrale d'air comprimé (ISO 22052:2020)
Le présent document spécifie les exigences et les méthodes d'essai relatives à une centrale d'air comprimé fournissant de l'air dentaire aux units dentaires et à divers dispositifs consommant de l'air dentaire dans le cabinet dentaire.
Il spécifie également les exigences de qualité et les méthodes d'essai relatives à l'air dentaire produit par la centrale d'air comprimé, telles que les exigences relatives au niveau de pureté de l'air dentaire.
Il spécifie également les exigences relatives aux informations devant être fournies par le fabricant sur les performances, l'installation, le fonctionnement et la maintenance de la centrale d'air comprimé.
Le présent document s'applique uniquement à une centrale d'air comprimé installée à l'extérieur de la salle de traitement dentaire.
Le présent document ne s'applique pas aux centrales d'air comprimé installées dans la salle de traitement dentaire, ni aux canalisations de l'installation. Le présent document ne contient pas d'exigences relatives aux applications en laboratoire dentaire (par exemple systèmes CFAO).
Zobozdravstvo - Oprema za centralno pripravo stisnjenega zraka (ISO 22052:2020)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22052:2020
01-september-2020
Zobozdravstvo - Oprema za centralno pripravo stisnjenega zraka (ISO 22052:2020)
Dentistry - Central compressed air source equipment (ISO 22052:2020)
Zahnheilkunde - Zentrale Druckluftversorgungsanlage (ISO 22052:2020)
Médecine bucco-dentaire - Centrale d'air comprimé (ISO 22052:2020)
Ta slovenski standard je istoveten z: EN ISO 22052:2020
ICS:
11.060.20 Zobotehnična oprema Dental equipment
SIST EN ISO 22052:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22052:2020
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SIST EN ISO 22052:2020
EN ISO 22052
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2020
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Central compressed air source equipment (ISO
22052:2020)
Médecine bucco-dentaire - Centrale d'air comprimé Zahnheilkunde - Zentrale Druckluftversorgungsanlage
(ISO 22052:2020) (ISO 22052:2020)
This European Standard was approved by CEN on 23 May 2020.
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, 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22052:2020 E
worldwide for CEN national Members.
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SIST EN ISO 22052:2020
EN ISO 22052:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 22052:2020
EN ISO 22052:2020 (E)
European foreword
This document (EN ISO 22052:2020) 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 January 2021, and conflicting national standards shall
be withdrawn at the latest by January 2021.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 22052:2020 has been approved by CEN as EN ISO 22052:2020 without any modification.
3
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SIST EN ISO 22052:2020
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SIST EN ISO 22052:2020
INTERNATIONAL ISO
STANDARD 22052
First edition
2020-06
Dentistry — Central compressed air
source equipment
Médecine bucco-dentaire — Centrale d’air comprimé
Reference number
ISO 22052:2020(E)
©
ISO 2020
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
ii © ISO 2020 – All rights reserved
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 4
5 Requirements . 5
5.1 Electrical safety . 5
5.2 Electromagnetic compatibility . 5
5.3 Quality of dental air . 5
5.4 Performance . 6
5.4.1 Air delivery flow rate of central compressed air source equipment . 6
5.4.2 Condensate drain . 6
5.4.3 Bacterial filter . 6
5.4.4 Sound level of central compressed air source equipment . 6
5.5 Test report . 6
6 Sampling . 6
7 Measurement and test methods . 7
7.1 Visual inspection . 7
7.1.1 General. 7
7.1.2 Visual inspection of equipment . 7
7.1.3 Visual inspection of documentation . 7
7.2 Equipment performance . 7
7.2.1 General test conditions . 7
7.2.2 Air delivery flow rate at the central compressed air source equipment
connection point . 7
7.2.3 Air treatment system performance . 8
7.2.4 Sound generation . 8
8 Information to be supplied by the manufacturer . 8
8.1 General . 8
8.2 Instructions for use . 8
8.3 Technical description . 9
8.4 Information about the central compressed air source equipment location .10
9 Marking .10
9.1 Marking on the central compressed air source equipment.10
9.2 Marking of controls .11
9.3 Graphical symbols .11
Annex A (informative) Example of design of central compressed air source equipment .12
Annex B (informative) Typical arrangements of central compressed air source equipment
in the dental facility and recommendations for construction and installation .14
Annex C (informative) Suggested template for test report .21
Bibliography .23
© ISO 2020 – All rights reserved iii
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SIST EN ISO 22052:2020
ISO 22052:2020(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 of ISO 22052 cancels and replaces ISO/TS 22595-2:2008.
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.
iv © ISO 2020 – All rights reserved
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
Introduction
Central compressed air source equipment is nearly universally present in modern dental treatment
facilities. It consists of components located separate from treatment rooms used to compress air,
prepare the air to meet quality requirements and to store the dental air for eventual use by treatment
room pneumatic devices such as air powered hand pieces and air-water syringes as well as for cooling
purposes.
Since the output of central compressed air source equipment is used in dental treatment, the equipment
characteristics as well as the quality characteristics of the dental air becomes the subject of this
document.
The requirements specified in this document have been developed with consideration for the dental air
requirements specified in ISO 7494-2.
In medical applications the quality of “air for medical use” is carefully defined. For example, in the
European Pharmacopeia and in other countries there are similar definitions. Air for medical use is used
for artificial breathing, anaesthetic, endoscopic and other applications inside the human body, also for
long term therapy. Also, it is used in sterile environments like operating rooms. For these applications
it is necessary to have a precise definition of the quality of the air. The European Pharmacopeia gives
values and limits for the contents of the air as well as limits for dangerous contaminants.
In dental applications, compressed air is used to supply driving power for treatment room pneumatic
devices such as air powered hand pieces (“drills”) and for drying an operating site. Air used for these
purposes intermittently enters a patient’s mouth and to a significant degree, can be quickly removed
by dental suction equipment. As the ambient air in the dental treatment room is not sterile, there is no
need for dental air to be sterile nor is there a need for the contents of dental air to be controlled beyond
the requirements of normal ambient air.
Nevertheless, there are some essential quality characteristics for the air used in dentistry:
a) to protect sensitive dental instruments and apparatus (from oil, water, particles);
b) to provide clean and dry air and to avoid that dental procedures are compromised (because oil is a
release agent that affects e.g. dental adhesion systems);
c) to protect against high humidity in the dental air that creates corrosion in the air receivers and air
lines and that can result in technical difficulties in dental instruments; also to protect against the
growth of microorganisms in the dental air system.
The test method in this document has been developed in response to the need for clear specification in
determining the quality of the dental air.
Up to now, there is no international standard available which defines the quality of “air for dental use”.
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SIST EN ISO 22052:2020
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SIST EN ISO 22052:2020
INTERNATIONAL STANDARD ISO 22052:2020(E)
Dentistry — Central compressed air source equipment
1 Scope
This document specifies requirements and test methods for central compressed air source equipment
supplying dental air for dental units and various dental air consuming devices in the dental office.
It also specifies quality requirements and test methods for the dental air produced by the central
compressed air source equipment, such as requirements for the purity level of dental air.
It also specifies requirements for information to be supplied by the manufacturer on the performance,
installation, operation and maintenance of the central compressed air source equipment.
This document applies only to central compressed air source equipment located outside of the dental
treatment room.
This document does not apply to central compressed air source equipment located in the dental
treatment room and facility piping. This document does not include requirements for dental laboratory
applications (e.g. CAD/CAM systems).
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 2151, Acoustics — Noise test code for compressors and vacuum pumps — Engineering method (Grade 2)
ISO 7494-2, Dentistry — Dental units — Part 2: Air, water, suction and wastewater systems
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 8573-2, Compressed air — Contaminant measurement — Part 2: Oil aerosol content
ISO 8573-3, Compressed air — Part 3: Test methods for measurement of humidity
ISO 8573-4, Compressed air — Contaminant measurement — Part 4: Particle content
ISO 9687, Dentistry — Graphical symbols for dental equipment
IEC 60335-1, Household and similar electrical appliances — Safety — Part 1: General requirements
IEC 61000-6-2, Electromagnetic compatibility (EMC) — Generic standards — Immunity for industrial
environments
IEC 61000-6-3, Electromagnetic compatibility (EMC) — Generic standards — Emission standard for
residential, commercial and light-industrial environments
IEC 60417, Graphical symbols for use on equipment
ISO 7000, Graphical symbols for use on equipment — Registered symbols
© ISO 2020 – All rights reserved 1
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
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 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 http:// www .electropedia .org/
3.1
air cooler
device designed to reduce the temperature of compressed air (3.9) to a desired level
3.2
air delivery flow rate
performance of central compressed air source equipment (3.8) defined as Normal litres per minutes
3.3
air dryer system
system designed to reduce the humidity of compressed air (3.9) to a desired level
EXAMPLE Adsorption dryer, membrane dryer, refrigeration dryer.
3.4
air filter
air treatment system component used to lower compressed air (3.9) particulate content
3.5
air intake filter
device designed to remove particles from intake air
3.6
air receiver
component used to store compressed air (3.9)
3.7
bacterial filter
device designed to restrict the passage of bacteria and to reduce bacteria in the dental air (3.14)
3.8
central compressed air source equipment
all components located between air intake and the central compressed air source equipment connection
point (3.17), excluding the suction tube (3.32) if present
3.9
compressed air
ambient air compressed to a higher-pressure level than ambient pressure
3.10
compressed air filter
device designed to remove solid particles from the compressed air (3.9) after the air dryer
3.11
compressor head
collection of mechanical components used to compress ambient air
Note 1 to entry: Compressor heads may be of various mechanical types such as piston and rotary screw.
2 © ISO 2020 – All rights reserved
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
3.12
compressor motor set
collection of components including one or more compressor heads (3.11) along with one or more
electrical drive motors
3.13
condensate drain
device to drain off condensed water from the air receiver (3.6), water separator, air dryer, air filter (3.4)
3.14
dental air
compressed air (3.9) for powering, controlling, and/or assisting various dental instruments and
equipment, as well as for assisting practitioners with procedures in the oral cavity, but not for procedures
requiring medical air or sterile air, such as endoscopy, oral surgery, analgesia, and life support
[SOURCE: ISO 7494-2:2015, 3.7, modified.]
3.15
dental air outlet
location at central compressed air source equipment (3.8) where the dental air (3.14) lines or additional
devices are connected to central compressed air source equipment
3.16
dental compressor
collection of components used to compress, treat and store air that meets dental air (3.14) specifications
for dental procedures
3.17
central compressed air source equipment connection point
location where the central compressed air source equipment (3.8) is connected to the main line for dental
air (3.25)
3.18
dewpoint
temperature at which water vapour begins to condense
3.19
exhaust air outlet
point where the cooling air exits central compressed air source equipment (3.8) location room
3.20
fittings
components that are used to connect the dental compressor (3.16), valves and devices with the pipes
3.21
flexible tube
hose or tube which connects the compressor with the central compressed air source equipment (3.8)
or with the connection point to the main line for dental air (3.25) or, if applicable the quick release
coupling device
3.22
fresh air inlet
location where central compressed air source equipment (3.8) can draw in the atmospheric air from a
source, where appropriate located outside the building
3.23
fresh air ventilation
place, where fresh air can enter central compressed air source equipment (3.8) location for ventilation,
cooling and compressing
© ISO 2020 – All rights reserved 3
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
3.24
intake muffler
device which reduces the noise level caused by the suction action of the compressor
3.25
main line for dental air
components of a piping installation in a dental facility used to transport dental air (3.14) from central
compressed air source equipment (3.8) to the dental treatment room and other rooms with various
dental air consuming devices
3.26
oil separator
device that is installed in oil-lubricated central compressed air source equipment (3.8) in order to reduce
the oil content of the compressed air (3.9)
3.27
central compressed air source equipment location
area outside the dental treatment room in a dental facility where equipment which supplies dental air
(3.14) to one or more treatment rooms are installed
3.28
pressure dewpoint
dewpoint (3.18) of the air at the specified pressure
3.29
pressure-regulating valve
device that controls the maximum air pressure delivered to the main line for dental air (3.25)
3.30
quick-release coupling device
device that is installed at the central compressed air source equipment (3.8) connection point to
disconnect the central compressed air source equipment from the main line for dental air (3.25) for
maintenance and measurement of air delivery flow rate (3.2), air humidity and noise level
3.31
shut-off valve
device that is used for maintenance to isolate central compressed air source equipment (3.8) from the
main line for dental air (3.25) installed between the air receiver (3.6) and the dental air outlet (3.15)
3.32
suction tube
component for connecting the fresh air inlet (3.22) with the compressor fresh air inlet
3.33
water separator
component of the air dryer system (3.3) used to remove liquid water from compressed air (3.9)
4 Classification
Central compressed air source equipment shall be classified according to the type of compressor
lubrication methods into the following two types:
Type 1: oil-lubricated compressor heads
Compressor heads are oil-lubricated.
For typical central compressed air source equipment arrangements of oil-lubricated compressor, see
B.1.1 and B.1.2, and Figures B.1 and B.2.
Type 2: non-oil-lubricated compressor heads
4 © ISO 2020 – All rights reserved
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
Compressor heads are not oil-lubricated.
For typical central compressed air source equipment arrangements of non-oil-lubricated compressor,
see B.1.3 and B.1.4, and Figures B.3 and B.4.
5 Requirements
5.1 Electrical safety
Dental compressors and other parts of the central compressed air source equipment are designed as
stationary equipment to be installed in a location separate from dental treatment rooms.
To prevent electrical conduction between central compressed air source equipment and the main
line for dental air in case of fault condition, hoses or tubes (flexible tubes), which connect the dental
compressor with the central compressed air source equipment connection point or, if applicable the
quick release coupling device, shall be made from an electrical insulating material.
For central compressed air source equipment, the safety requirements of IEC 60335-1 apply.
Testing shall be carried out in accordance with IEC 60335-1.
5.2 Electromagnetic compatibility
For electromagnetic compatibility (EMC), the following requirements shall apply.
Immunity requirements of IEC 61000-6-2 shall apply.
Testing shall be carried out in accordance with IEC 61000-6-2.
Emission requirements of IEC 61000-6-3 shall apply.
Testing shall be carried out in accordance with IEC 61000-6-3.
5.3 Quality of dental air
The dental air produced by the central compressed air source equipment shall conform to purity class
[2:4:2] according ISO 8573-1.
Explanation of purity class [2:4:2]:
Particle class 2: The numbers of particle in the dental air are as follows:
Particle size Number of particles per cubic metre
0,1 μm < d ≤ 0,5 μm ≤ 400 000
0,5 μm < d ≤ 1,0 μm ≤ 6 000
1,0 μm < d ≤ 5,0 μm ≤ 100
Humidity class 4: The pressure dewpoint is ≤ +3 °C at 20 °C medium temperature and at 0,7 MPa
constant system pressure (this is equivalent to an atmospheric dewpoint of ≤ −21 °C).
3
Oil content class 2: The oil content of the dental air is ≤ 0,1 mg/m .
Testing shall be carried out in accordance with 7.2.3.1, 7.2.3.2, 7.2.3.3.
NOTE 1 In ISO 8573-1 the classification for humidity is defined in relation to the gas temperature.
© ISO 2020 – All rights reserved 5
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SIST EN ISO 22052:2020
ISO 22052:2020(E)
NOTE 2 Several air dryer systems create a
...
SLOVENSKI STANDARD
oSIST prEN ISO 22052:2019
01-julij-2019
Zobozdravstvo - Oprema za centralno pripravo stisnjenega zraka (ISO/DIS
22052:2019)
Dentistry - Central compressed air source equipment (ISO/DIS 22052:2019)
Médecine bucco-dentaire - Centrale d'air comprimé (ISO/DIS 22052:2019)
Ta slovenski standard je istoveten z: prEN ISO 22052
ICS:
11.060.20 Zobotehnična oprema Dental equipment
oSIST prEN ISO 22052:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 22052:2019
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oSIST prEN ISO 22052:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 22052
ISO/TC 106/SC 6 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-05-13 2019-08-05
Dentistry - Central compressed air source equipment
Médecine bucco-dentaire — Matériel générant une source d’air comprimé centrale
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 22052:2019(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 2019
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oSIST prEN ISO 22052:2019
ISO/DIS 22052:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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oSIST prEN ISO 22052:2019
ISO/DIS 22052:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 4
4.1 According to compressor head lubrication . 4
4.2 According to mode of operation . 5
5 Requirements . 5
5.1 Electrical safety . 5
5.2 Electromagnetic compatibility . 5
5.3 Performance . 6
5.3.1 Air delivery flow rate of central compressed air source equipment . 6
5.3.2 Condensate drain . 6
5.3.3 Bacterial filter . 6
5.3.4 Sound level of central compressed air source equipment . 6
5.4 Test report . 7
6 Sampling . 7
7 Measurement and test methods . 7
7.1 Visual inspection . 7
7.1.1 General. 7
7.1.2 Visual inspection of equipment . 7
7.1.3 Visual inspection of documentation . 7
7.2 Equipment performance . 7
7.2.1 General test conditions . 7
7.2.2 Air delivery flow rate at the central compressed air source equipment
connection point . 7
7.2.3 Air treatment system performance . 8
8 Information to be supplied by the manufacturer . 8
8.1 General . 8
8.2 Instructions for use . 9
8.3 Technical description . 9
8.4 Information about the central compressed air source equipment location .10
9 Marking .10
9.1 Marking on the central compressed air source equipment.10
9.2 Marking of controls .11
9.3 Graphical symbols .11
Annex A (informative) Example of design of compressed air source equipment .12
Annex B (informative) Typical arrangements of central compressed air source equipment
in the compressor location .14
Annex C (informative) Test report .21
Bibliography .23
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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.
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.
ISO 22052 was developed from ISO/TS 22595-2:2008, Dentistry — Plant area equipment — Part 2:
Compressor systems. Due to a huge number of modifications the title was changed to ISO 22052 Dentistry
– Central compressed air source equipment.
ISO 22052 replaces ISO/TS 22595-2:2008.
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Introduction
Central compressed air source equipment is nearly universally present in modern dental treatment
facilities. It consists of components located separate from treatment rooms used to compress air,
prepare the air to meet quality requirements and to store the dental air for eventual use by treatment
room pneumatic devices such as air powered hand pieces and air-water syringes as well as for cooling
purposes.
Since the output of central compressed air source equipment is used in dental treatment, the equipment
characteristics as well as the quality characteristics of the dental air becomes the subject of this
document.
The requirements specified in this document have been developed with consideration for the dental air
requirements specified in ISO 7494-2.
In medical applications the quality of “air for medical use” is carefully defined. For example in the
European Pharmacopeia and in other countries there are similar definitions. Air for medical use is used
for artificial breathing, anaesthetic, endoscopic and other applications inside the human body, also for
long term therapy. Also it is used in sterile environments like operating rooms. For these applications
it is necessary to have a precise definition of the quality of the air. The European Pharmacopeia gives
values and limits for the contents of the air as well as limits for dangerous contaminants.
In dental applications, compressed air is used to supply driving power for treatment room pneumatic
devices such as air powered hand pieces (“drills”) and for drying an operating site. Air used for these
purposes intermittently enters a patient’s mouth and to a significant degree, may be quickly removed
by dental suction equipment. As the ambient air in the dental treatment room is not sterile, there is no
need for dental air to be sterile nor is there a need for the contents of dental air to be controlled beyond
the requirements of normal ambient air.
Nevertheless, there are some basic requirements for the air used in dentistry:
a) to protect sensitive dental instruments and apparatus (from oil, water, particles);
b) to provide clean and dry air and to avoid that dental procedures are compromised (because oil is a
release agent it affects e. g. dental adhesion systems);
c) high humidity in the dental air will create corrosion in the air receivers and air lines and may result
in technical difficulties in dental instruments; also it supports the growth of microorganisms in the
dental air system.
Therefore it is necessary to have a clear definition of the quality of the dental air used in a dental
practice.
Up to now, there is no International Standard available which defines the quality of “air for dental use”
and how it differs from “air for medical use”.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 22052:2019(E)
Dentistry - Central compressed air source equipment
1 Scope
This document specifies requirements and test methods for central compressed air source equipment
supplying dental air for dental units and various dental air consuming devices in the dental office.
It also specifies quality requirements and test methods for the dental air produced by the central
compressed air source equipment, such as requirements for the purity level of dental air.
It also specifies requirements for information to be supplied by the manufacturer on the performance,
installation, operation and maintenance of the central compressed air source equipment.
This document applies only to central compressed air source equipment located outside of the dental
treatment room.
Central compressed air source equipment located in the dental treatment room and facility piping are
excluded from the scope of this document.
This document does not include requirements for dental laboratory applications (e. g. CAD/CAM
systems)
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 2151, Acoustics — Noise test code for compressors and vacuum pumps — Engineering method (Grade 2)
ISO 7494-2, Dentistry — Dental units — Part 2: Air, water, suction and wastewater systems
ISO 8573-1, Compressed air — Part 1: Contaminants and purity classes
ISO 8573-2, Compressed air — Contaminant measurement — Part 2: Oil aerosol content
ISO 8573-3:1999, Compressed air — Part 3: Test methods for measurement of humidity
ISO 8573-4, Compressed air — Contaminant measurement — Part 4: Particle content
ISO 9687, Dentistry — Graphical symbols for dental equipment
ISO 10637, Dentistry — Central suction source equipment
IEC 60335-1, Household and similar electrical appliances — Safety — Part 1: General requirements
IEC 61000-6-2, Electromagnetic compatibility (EMC) — Generic standards — Immunity for industrial
environments
IEC 61000-6-3, Electromagnetic compatibility (EMC) — Generic standards — Emission standard for
residential, commercial and light-industrial environments
IEC 60417-1, Graphical symbols for use on equipment — Part 1: Overview and application
ISO 7000, Graphical symbols for use on equipment — Registered symbols
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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 and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
air cooler
device designed to reduce the temperature of compressed air to a desired level
3.2
air delivery flow rate
performance of central compressed air source equipment defined as Normal liters per minutes
3.3
air dryer system
system designed to reduce the humidity of compressed air to a desired level
EXAMPLE Adsorption dryer, membrane dryer, refrigeration dryer.
3.4
air filter
air treatment system component used to lower compressed air particulate content
3.5
air intake filter
device designed to remove particles from intake air
3.6
air receiver
component used to store compressed air
3.7
bacterial filter
device designed to restrict the passage of bacteria and to reduce bacteria in the dental air
3.8
central compressed air source equipment
all components located between facility fresh air inlet and the central compressed air source equipment
connection point, excluding the suction tube if present
3.9
compressed air
ambient air compressed to a higher pressure level than ambient pressure
3.10
compressed air filter
device designed to remove solid particles from the compressed air after the air dryer
3.11
compressor head
collection of mechanical components used to compress ambient air
Note 1 to entry: Compressor heads may be of various mechanical types such as piston and rotary screw.
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3.12
compressor motor set
collection of components including one or more compressor heads along with one or more electrical
drive motors
3.13
condensate drain
device to drain off condensed water from the air receiver, water separator, air dryer, air filter
3.14
dental air
compressed air for powering, controlling, and/or assisting various dental instruments and equipment,
as well as for assisting practitioners with procedures in the oral cavity, but not for procedures requiring
medical air or sterile air, such as endoscopy, oral surgery, analgesia, and life support
[SOURCE: ISO 7494-2, 2015, 3.7]
3.15
dental air outlet
location at central compressed air source equipment where the dental air lines or additional devices are
connected to central compressed air source equipment
3.16
dental compressor
collection of components used to compress, treat and store air that meets dental air specifications for
dental procedures
3.17
central compressed air source equipment connection point
location where the central compressed air source equipment is connected to the main line for dental air
3.18
dewpoint
temperature at which water vapour begins to condense
3.19
exhaust air outlet
point where the cooling air exits central compressed air source equipment location room.
3.20
fittings
components that are used to connect the dental compressor, valves and devices with the pipes
3.21
flexible tube
hose or tube which connects the compressor with the remain central compressed air source equipment or
with the connection point to the main line for dental air or, if applicable the quick release coupling device
3.22
fresh air inlet
location where central compressed air source equipment can draw in the atmospheric air from a source
located outside the building
3.23
fresh air ventilation
place, where fresh air can enter central compressed air source equipment location for ventilation,
cooling and compressing
3.24
intake muffler
device which reduces the noise level caused by the suction action of the compressor
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3.25
main line for dental air
components of a piping installation in a dental facility used to transport dental air from central
compressed air source equipment to the dental treatment room and other rooms with various dental
air consuming devices
3.26
oil separator
device that is installed in oil-lubricated central compressed air source equipment in order to reduce the
oil content of the compressed air
3.27
central compressed air source equipment location
area outside the dental treatment room in a dental facility where equipment which supplies dental air
to one or more treatment rooms are installed
3.28
pressure dewpoint
dewpoint of the air at the specified pressure
3.29
pressure-regulating valve
device that controls the maximum air pressure delivered to the main line for dental air
3.30
quick-release coupling device
device that is installed at the central compressed air source equipment connection point to disconnect
the central compressed air source equipment from the main line for dental air for maintenance and
measurement of air delivery flow rate, air humidity and noise level
3.31
shut-off valve
device that is used for maintenance to isolate central compressed air source equipment from the main
line for dental air installed between the air receiver and the dental air outlet
3.32
suction tube
component for connecting the fresh air inlet with the compressor fresh air inlet
3.33
water separator
component of the air dryer system used to remove liquid water from compressed air
4 Classification
4.1 According to compressor head lubrication
Central compressed air source equipment shall be classified according to the type of compressor
lubrication methods into the following two types:
Type 1: oil-lubricated compressor heads
Compressor heads are oil-lubricated.
For typical central compressed air source equipment arrangements of oil-lubricated compressor, see
Annex B.1.1 and B.1.2.
Type 2: non-oil-lubricated compressor heads
Compressor heads are not oil-lubricated.
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For typical central compressed air source equipment arrangements of non-oil-lubricated compressor,
see Annex B.1.3 and B.1.4.
4.2 According to mode of operation
Central compressed air source equipment shall be classified according to the mode of operation into the
following two classes:
Class 1: continuous operation
Central compressed air source equipment is able to continuously deliver the maximum specified flow
rate at the required air quality.
Class 2: non-continuous operation
Central compressed air source equipment is not able to continuously deliver the maximum specified
flow rate at the required air quality.
5 Requirements
5.1 Electrical safety
Dental compressors and other parts of the central compressed air source equipment are designed as
stationary equipment to be installed in a location separate from dental treatment rooms.
To prevent electrical conduction between central compressed air source equipment and the main
line for dental air in case of fault condition, hoses or tubes (flexible tubes), which connect the dental
compressor with the central compressed air source equipment connection point or, if applicable the
quick release coupling device, shall be made from an electrical insulating material.
For central compressed air source equipment the safety requirements of IEC 60335-1 apply.
Testing shall be carried out in accordance with IEC 60335-1.
5.2 Electromagnetic compatibility
For electromagnetic compatibility (EMC), the following requirements shall apply.
Immunity requirements of IEC 61000-6-2 shall apply. Testing shall be carried out in accordance with
IEC 61000-6-2.
Emission requirements of IEC 61000-6-3 shall apply. Testing shall be carried out in accordance with IEC
61000-6-3.
Quality of dental air
The dental air produced by the central compressed air source equipment shall conform to purity class
[2:4:2] according ISO 8573-1.
Explanation of purity-class [2:4:2]:
Particle class 2: The numbers of particle in the dental air are as follows:
Particle size Number of particle
0,1 μm < d ≤ 0,5 μm ≤ 400 000
0,5 μm < d ≤ 1,0 μm ≤ 6 000
1,0 μm < d ≤ 5,0 μm ≤ 100
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Humidity class 4: The pressure dewpoint is ≤ +3°C at 20°C medium temperature and at 0,7 MPa
constant system pressure (this is equivalent to an atmospheric dewpoint of ≤ -21°C).
3
Oil content class 2: The oil content of the dental air is ≤ 0,1 mg/m .
Testing shall be carried out in accordance with 7.2.3.1, 7.2.3.2, 7.2.3.3.
NOTE 1 In ISO 8573-1 the classification for humidity is defined in relation to the gas temperature.
NOTE 2 Several air dryer systems create a dewpoint depression in relation to the ambient temperature. To
make the measuring simpler, the pressure dewpoint is defined in relation to the ambient temperature in this
document
NOTE 3 According to ISO 8573-3:1999, Clause 8.1, the reference conditions for humidity statements are
defined as:
a) compressed air temperature 20°C;
b) compressed air pressure 0.7 MPa.
5.3 Performance
5.3.1 Air delivery flow rate of central compressed air source equipment
The manufacturer of central compressed air source equipment shall specify the maximum air delivery
flow rate that the equipment is intended to deliver at 0,5 MPa.
Measurements shall be carried out in accordance with 7.2.1 and 7.2.2.
NOTE As a minimum requirement the central compressed air source equipment should provide a continuous
air flow at atmospheric pressure of at least 50 Nl/min while maintaining a pressure of 0,5 MPa. If additional air
consuming devices are installed the necessary delivery rate of the central compressed air source equipment may
be higher than the basic recommendation. In this case, the performance of the central compressed air source
equipment should be defined according to the average operation mode of the entire practice.
5.3.2 Condensate drain
The system shall be equipped with a mechanism to drain off condensate water from all points where
condensation may occur, for example a condensate drain at the lowest point of the air receiver, filter
and/or dryer.
Compliance shall be checked in accordance with 7.1.2.
5.3.3 Bacterial filter
If the central compressed air source equipment includes a bacterial filter it shall be rated to restrict the
passage of contaminants larger than 0,22 μm with a retention of 99,99 %.
The manufacturer shall specify the method and interval for the filter element replacement.
Compliance shall be checked in accordance with 7.1.
5.3.4 Sound level of central compressed air source equipment
The sound pressure level of central compressed air source equipment shall be measured and reported.
Testing shall be carried out according 7.2.3.4.
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5.4 Test report
A test report shall be prepared to report the results of all applicable testing and inspection requirements
...
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