Dentistry — Central compressed air source equipment

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).

Médecine bucco-dentaire — Centrale d’air comprimé

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).

General Information

Status
Published
Publication Date
22-Jun-2020
Current Stage
6060 - International Standard published
Start Date
23-Apr-2020
Completion Date
23-Jun-2020
Ref Project

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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
---------------------- Page: 1 ----------------------
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
---------------------- Page: 2 ----------------------
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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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
---------------------- Page: 4 ----------------------
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”.

© ISO 2020 – All rights reserved v
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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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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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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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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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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).

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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ISO 22052:2020(E)

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, 8.1, the reference conditions for humidity statements are defined as:

a) compressed air temperature 20 °C;
b) compressed air pressure 0,7 MPa.
5.4 Performance
5.4.1 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 continuously at 0,5 MPa and at the air quality

requirement specified under 5.3.
Measurements shall be carried out in accordance with 7.2.1 and 7.2.2.
5.4.2 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.
Conformity shall be checked in accordance with 7.1.2.
5.4.3 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.

Conformity shall be checked in accordance with 7.1.3
5.4.4 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 to 7.2.4.
5.5 Test report

A test report shall be prepared to report the results of all applicable testing and inspection requirements

specified in this document. Annex C gives a suggested template for the test report.

6 Sampling

One representative sample of the central compressed air source equipment shall be tested.

6 © ISO 2020 – All rights reserved
---------------------- Page: 11 ----------------------
ISO 22052:2020(E)
7 Measurement and test methods
7.1 Visual inspection
7.1.1 General
Visual inspection shall be carried out at normal visual acuity.
7.1.2 Visual inspection of equipment
Visually inspect the equipment to determine conformity with the requirements.
7.1.3 Visual inspection of documentation

Visually inspect the documentation provided by the manufacturer to determine conformity with the

requirements.
7.2 Equipment performance
7.2.1 General test conditions
The tests shall be carried out under the following test conditions:

a) The output pressure of the central compressed air source equipment shall be set to the required

pressure by using the pressure regulating valve;
b) the flow rate shall be set as specified in 5.4.1;
c) ambient temperature of (20 ± 2) °C;
d) the relative humidity, as specified in the instructions for use;
e) the atmospheric pressure, as specified in the instructions for use.

NOTE According to ISO 8573-3:1999, 8.1 the reference conditions for humidity statements are defined as:

a) compressed air temperature 20 °C;
b) compressed air pressure 0,7 MPa.

7.2.2 Air delivery flow rate at the central compressed air source equipment connection point

Install a pressure regulating valve at the central compressed air source equipment connection point or,

if applicable the quick release coupling device. Set the pressure to the value given in the technical data

of the central compressed air source equipment (e.g. 0,5 MPa).

Activate the system and run it for (30 ± 2) min with the flow set to the maximum continuous flow

performance stated by the manufacturer.

If maximum time specified by the manufacturer is less than 30 min, activate the system and run it

for (30 ± 2) min or maximum running time without stops with the flow set to the maximum flow

performance stated by the manufacturer.

Measure the air delivery flow rate, gas temperature and humidity at the central compressed air source

equipment connection point or, if applicable the quick release coupling device; convert the measured

values to Normal litres under following conditions:
© ISO 2020 – All rights reserved 7
---------------------- Page: 12 ----------------------
ISO 22052:2020(E)
Pressure 0,1 MPa (abs)
Temperature 20 °C or 293,15 K
Gas constant of air 288 J/kgK
Density of air 1,185 kg/m
Rel. Humidity of air 65 % RH

Include in the test apparatus a flow measuring device capable of ± 5 % accuracy traceable to an

international or national standard.
7.2.3 Air treatment system performance

Connect a measuring device behind the central compressed air source equipment connection point or,

if applicable the quick release coupling device. Activate central compressed air source equipment by

setting the air con
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22052
ISO/TC 106/SC 6
Dentistry — Central compressed air
Secretariat: DIN
source equipment
Voting begins on:
2020­02­26
Voting terminates on:
2020­04­22
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 22052:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 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
CH­1214 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 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 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 .........................................................................................................22

Bibliography .............................................................................................................................................................................................................................24

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 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 non­governmental, 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 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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ISO/FDIS 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 it 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”.

© ISO 2020 – All rights reserved v
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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 7494­2, Dentistry — Dental units — Part 2: Air, water, suction and wastewater systems

ISO 8573­1, Compressed air — Part 1: Contaminants and purity classes

ISO 8573­2, Compressed air — Contaminant measurement — Part 2: Oil aerosol content

ISO 8573­3, Compressed air — Part 3: Test methods for measurement of humidity
ISO 8573­4, Compressed air — Contaminant measurement — Part 4: Particle content
ISO 9687, Dentistry — Graphical symbols for dental equipment

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

IEC 61000­6­2, Electromagnetic compatibility (EMC) — Generic standards — Immunity for industrial

environments

IEC 61000­6­3, Electromagnetic compatibility (EMC) — Generic standards — Emission standard for

residential, commercial and light-industrial environments

IEC 60417­1, 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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ISO/FDIS 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 higher­pressure 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.

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ISO/FDIS 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 7494­2, 2015, 3.7]
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 remain 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
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ISO/FDIS 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 oil­lubricated 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 oil­lubricated.

For typical central compressed air source equipment arrangements of oil-lubricated compressor, see

B.1 and B.2, and Figures B.1 and B.2.
Type 2: non-oil-lubricated compressor heads
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ISO/FDIS 22052:2020(E)
Compressor heads are not oil­lubricated.

For typical central compressed air source equipment arrangements of non-oil-lubricated compressor,

see B.3 and B.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 60335­1.
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 61000­6­2.
Emission requirements of IEC 61000-6-3 shall apply.
Testing shall be carried out in accordance with IEC 61000­6­3.
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 8573­1.
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).

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.

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ISO/FDIS 22052:2020(E)

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, 8.1, the reference conditions for humidity statements are defined as:

a) compressed air temperature 20 °C;
b) compressed air pressure 0,7 MPa.
5.4 Performance
5.4.1 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 continuously at 0,5 MPa and at the air quality

requirement specified under 5.3.
Measurements shall be carried out in accordance with 7.2.1 and 7.2.2.
5.4.2 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.
Conformity shall be checked in accordance with 7.1.2.
5.4.3 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.

Conformity shall be checked in accordance with 7.1.3
5.4.4 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 to 7.2.3.4.
5.5 Test report

A test report shall be prepared to report the results of all applicable testing and inspection requirements

specified in this document. Annex C gives a suggested template for the test report.

6 Sampling

One representative sample of the central compressed air source equipment shall be tested.

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ISO/FDIS 22052:2020(E)
7 Measurement and test methods
7.1 Visual inspection
7.1.1 General
Visual inspection shall be carried out at normal visual acuity.
7.1.2 Visual inspection of equipment
Visually inspect the equipment to determine conformity with the requirements.
7.1.3 Visual inspection of documentation

Visually inspect the documentation provided by the manufacturer to determine conformity with the

requirements.
7.2 Equipment performance
7.2.1 General test conditions
The tests shall be carried out under the following test conditions:

a) The output pressure of the central compressed air source equipment shall be set to the required

pressure by using the pressure regulating valve;
b) the flow rate shall be set as specified in 5.4.1;
c) ambient temperature, of (20 ± 2) °C;
d) the relative humidity, as specified in the instructions for use;
e) the atmospheric pressure, as specified in the instructions for use.

NOTE According to ISO 8573-3:1999, 8.1 the reference conditions for humidity statements are defined as:

a) compressed air temperature 20 °C;
b) compressed air pressure 0,7 MPa.

7.2.2 Air delivery flow rate at the central compressed air source equipment connection point

Install a pressure regulating valve at the central compressed air source equipment connection point or,

if applicable the quick release coupling device. Set the pressure to the value given in the technical data

of the central compressed air source equipment (e.g. 0,5 MPa).

For class 1: activate the system and run it for (30 ± 2) min with the flow set to the maximum continuous

flow performance stated by the manufacturer.

For class 2: activate the system and run it for (30 ± 2) min or maximum running time without stops (if

maximum time specified by the manufacturer is less than 30 min) with the flow set to the maximum

flow performance stated by the manufacturer.

Measure the air delivery flow rate, gas temperature and humidity at the central compressed air source

equipment connection point or, if applicable the quick release coupling device; convert the measured

values to N
...

NORME ISO
INTERNATIONALE 22052
Première édition
2020-06
Médecine bucco-dentaire — Centrale
d’air comprimé
Dentistry — Central compressed air source equipment
Numéro de référence
ISO 22052:2020(F)
ISO 2020
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ISO 22052:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020

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ii © ISO 2020 – Tous droits réservés
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ISO 22052:2020(F)
Sommaire Page

Avant-propos ..............................................................................................................................................................................................................................iv

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

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 2

4 Classification ............................................................................................................................................................................................................ 4

5 Exigences ...................................................................................................................................................................................................................... 5

5.1 Sécurité électrique ............................................................................................................................................................................... 5

5.2 Compatibilité électromagnétique ........................................................................................................................................... 5

5.3 Qualité de l’air dentaire ................................................................................................................................................................... 5

5.4 Performances ........................................................................................................................................................................................... 6

5.4.1 Débit d’air de la centrale d’air comprimé ................................................................................................... 6

5.4.2 Purgeur de condensat.................................................................................................................................................. 6

5.4.3 Filtre bactérien .................................................................................................................................................................. 6

5.4.4 Niveau de bruit de la centrale d’air comprimé ...................................................................................... 6

5.5 Rapport d’essai ....................................................................................................................................................................................... 6

6 Échantillonnage ..................................................................................................................................................................................................... 6

7 Méthodes de mesure et d’essai .............................................................................................................................................................. 7

7.1 Examen visuel .......................................................................................................................................................................................... 7

7.1.1 Généralités ............................................................................................................................................................................ 7

7.1.2 Examen visuel du matériel ...................................................................................................................................... 7

7.1.3 Examen visuel de la documentation ............................................................................................................... 7

7.2 Performances du matériel ............................................................................................................................................................. 7

7.2.1 Conditions générales d’essai ................................................................................................................................. 7

7.2.2 Débit d’air au point de branchement de la centrale d’air comprimé .................................. 7

7.2.3 Performances du système de traitement de l’air ................................................................................. 8

7.2.4 Émission sonore ............................................................................................................................................................... 8

8 Informations à fournir par le fabricant ........................................................................................................................................ 8

8.1 Généralités .................................................................................................................................................................................................. 8

8.2 Instructions d’utilisation ................................................................................................................................................................ 8

8.3 Description technique....................................................................................................................................................................... 9

8.4 Informations relatives au local de la centrale d’air comprimé ...................................................................10

9 Marquage ...................................................................................................................................................................................................................10

9.1 Marquage sur la centrale d’air comprimé ....................................................................................................................10

9.2 Marquage des organes de commande ..............................................................................................................................11

9.3 Symboles graphiques ......................................................................................................................................................................11

Annexe A (informative) Exemple de conception d’une centrale d’air comprimé ...............................................12

Annexe B (informative) Configurations types de centrale d’air comprimé dans le cabinet

dentaire et recommandations relatives à la construction et l’installation ..........................................14

Annexe C (informative) Modèle suggéré pour le rapport d’essai ........................................................................................21

Bibliographie ...........................................................................................................................................................................................................................23

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ISO 22052:2020(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

Le présent document a été élaboré par le comité technique ISO/TC 106, Médecine bucco-dentaire, sous-

comité SC 6, Matériel dentaire.
Cette première édition de l'ISO 22052 annule et remplace l’ISO/TS 22595-2:2008.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
iv © ISO 2020 – Tous droits réservés
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ISO 22052:2020(F)
Introduction

Une centrale d’air comprimé est presque toujours présente dans les installations de traitement dentaire

modernes. Elle est constituée de composants installés à distance des salles de traitement et utilisés pour

comprimer l’air, préparer l’air conformément aux exigences de qualité et stocker l’air dentaire en vue de

son utilisation ultérieure par les dispositifs pneumatiques de la salle de traitement, tels que les pièces à

main alimentées par air comprimé et les seringues air/eau ainsi qu’à des fins de refroidissement.

Étant donné que le produit de la centrale d’air comprimé est utilisé dans le traitement dentaire, les

caractéristiques du matériel ainsi que les caractéristiques de qualité de l’air dentaire deviennent l’objet

du présent document.

Les exigences spécifiées dans le présent document ont été établies en tenant compte des exigences

relatives à l’air dentaire spécifiées dans l’ISO 7494-2.

Dans les applications médicales, la qualité de l’«air à usage médical» est soigneusement définie. Il existe

des définitions similaires, par exemple dans la Pharmacopée européenne et dans d’autres pays. L’air à

usage médical est utilisé pour la respiration artificielle, l’anesthésie, l’endoscopie et d’autres applications

à l’intérieur du corps humain, ainsi que pour des thérapies à long terme. Il est également utilisé dans

des environnements stériles comme les blocs opératoires. Pour ces applications, il est nécessaire de

disposer d’une définition précise de la qualité de l’air. La Pharmacopée européenne donne des valeurs

et des limites pour le contenu de l’air ainsi que des limites pour les polluants dangereux.

Dans les applications dentaires, l’air comprimé est utilisé pour fournir l’énergie motrice aux dispositifs

pneumatiques de la salle de traitement, tels que les pièces à main alimentées par air comprimé

(«roulettes»), et pour sécher le champ opératoire. L’air utilisé à ces fins pénètre de façon intermittente

dans la bouche du patient et peut, en grande partie, être rapidement éliminé par le matériel d’aspiration

dentaire. Étant donné que l’air ambiant dans la salle de traitement dentaire n’est pas stérile, il n’y a pas

lieu que l’air dentaire soit stérile ni que son contenu soit contrôlé au-delà des exigences relatives à l’air

ambiant normal.

Néanmoins, certaines caractéristiques de qualité essentielles s’appliquent à l’air utilisé en médecine

bucco-dentaire:

a) pour protéger (de l’huile, de l’eau, des particules) les instruments et appareils dentaires sensibles;

b) pour fournir de l’air propre et sec et pour éviter que les techniques dentaires ne soient compromises

(l’huile étant un agent de démoulage, elle affecte, par exemple, les systèmes d’adhérence dentaire);

c) pour protéger contre une humidité élevée de l’air dentaire, qui engendre une corrosion dans les

réservoirs et les conduites d’air comprimé et qui peut entraîner des problèmes techniques dans

les instruments dentaires; pour protéger également contre le développement de micro-organismes

dans le système d’air dentaire.

La méthode d’essai décrite dans le présent document a été élaborée afin de répondre au besoin d’une

spécification claire pour déterminer la qualité de l’air dentaire.

Jusqu’à présent, il n’existait pas de Norme internationale disponible définissant la qualité de l’«air à

usage dentaire».
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NORME INTERNATIONALE ISO 22052:2020(F)
Médecine bucco-dentaire — Centrale d’air comprimé
1 Domaine d’application

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).

2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s’applique (y compris les

éventuels amendements).
ISO 1942, Médecine bucco-dentaire — Vocabulaire

ISO 2151, Acoustique — Code d'essai acoustique pour les compresseurs et les pompes à vide — Méthode

d'expertise (classe de précision 2)

ISO 7494-2, Médecine bucco-dentaire — Units dentaires — Partie 2: Systèmes d'alimentation en air et en

eau, d'aspiration et d'évacuation des eaux usées
ISO 8573-1, Air comprimé — Partie 1: Polluants et classes de pureté

ISO 8573-2, Air comprimé — Mesurage de contaminants — Partie 2: Teneur en aérosols d'huile

ISO 8573-3, Air comprimé — Partie 3: Méthodes d'essai pour mesurer le taux d'humidité

ISO 8573-4, Air comprimé — Mesurage des polluants — Partie 4: Teneur en particules

ISO 9687, Médecine bucco-dentaire — Symboles graphiques pour matériel dentaire

IEC 60335-1, Appareils électrodomestiques et analogues — Sécurité — Partie 1: Exigences générales

IEC 61000-6-2, Compatibilité électromagnétique (CEM) — Partie 6-2: Normes génériques — Immunité

pour les environnements industriels

IEC 61000-6-3, Compatibilité électromagnétique (CEM) — Partie 6-3: Normes génériques — Norme sur

l’émission pour les environnements résidentiels, commerciaux et de l’industrie légère

IEC 60417, Symboles graphiques utilisables sur le matériel
ISO 7000, Symboles graphiques utilisables sur le matériel — Symboles enregistrés
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ISO 22052:2020(F)
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions de l’ISO 1942, l’ISO 7494-2 ainsi que les

suivants, s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp;

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/ .
3.1
refroidisseur d’air

dispositif conçu pour réduire la température de l’air comprimé (3.9) au niveau souhaité

3.2
débit d’air

performance d’une centrale d’air comprimé (3.8), définie en litres normaux par minute

3.3
système de séchage de l’air
système conçu pour réduire l’humidité de l’air comprimé (3.9) au niveau souhaité
EXEMPLE Sécheur à adsorption, sécheur à membranes, sécheur frigorifique.
3.4
filtre à air

composant d’un système de traitement de l’air utilisé pour réduire la teneur en particules de l’air

comprimé (3.9)
3.5
filtre d’entrée d’air
dispositif conçu pour éliminer les particules de l’air d’admission
3.6
réservoir d’air comprimé
composant utilisé pour stocker l’air comprimé (3.9)
3.7
filtre bactérien

dispositif conçu pour limiter le passage des bactéries et pour réduire les bactéries dans l’air dentaire (3.14)

3.8
centrale d’air comprimé

ensemble des composants installés entre l’entrée d’air et le point de branchement de la centrale d’air

comprimé (3.17), à l’exclusion du tube d’aspiration (3.32) s’il existe
3.9
air comprimé
air ambiant comprimé à un niveau de pression supérieur à la pression ambiante
3.10
filtre à air comprimé

dispositif conçu pour éliminer les particules solides de l’air comprimé (3.9) en aval du sécheur d’air

3.11
tête de compresseur
ensemble de composants mécaniques utilisés pour comprimer l’air ambiant

Note 1 à l'article: Les têtes de compresseur peuvent être de différents types mécaniques, par exemple à pistons et

rotatif à vis.
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ISO 22052:2020(F)
3.12
groupe motocompresseur

ensemble de composants comprenant une ou plusieurs têtes de compresseur (3.11) avec un ou plusieurs

moteurs d’entraînement électriques
3.13
purgeur de condensat

dispositif permettant d’évacuer l’eau de condensation du réservoir d’air comprimé (3.6), du séparateur

d’eau, du sécheur d’air et du filtre à air (3.4)
3.14
air dentaire

air comprimé (3.9) pour alimenter, contrôler et/ou assister plusieurs instruments et matériels dentaires,

ainsi que pour assister les praticiens lors d’opérations effectuées dans la cavité buccale, mais pas lors

d’opérations nécessitant de l’air médical ou stérile (endoscopie, chirurgie buccale, analgésie, traitement

essentiel à la survie, par exemple)
[SOURCE: ISO 7494-2:2015, 3.7, modifiée.]
3.15
sortie d’air dentaire

emplacement au niveau de la centrale d’air comprimé (3.8) où les conduites d’air dentaire (3.14) ou

d’autres dispositifs sont raccordé(e)s à la centrale d’air comprimé
3.16
compresseur dentaire

ensemble de composants utilisé pour comprimer, traiter et stocker un air correspondant aux

spécifications de l’air dentaire (3.14) pour les techniques dentaires
3.17
point de branchement de la centrale d’air comprimé

emplacement où la centrale d’air comprimé (3.8) est raccordée à la conduite principale d’air dentaire (3.25)

3.18
point de rosée
température à laquelle la vapeur d’eau commence à se condenser
3.19
sortie d’air d’échappement

point où l’air de refroidissement sort du local dans lequel est installée la centrale d’air comprimé (3.8)

3.20
raccords

composants utilisés pour raccorder le compresseur dentaire (3.16), les vannes et les dispositifs aux tuyaux

3.21
tuyau souple

tuyau ou tube reliant le compresseur à la centrale d’air comprimé (3.8) ou au point de branchement à la

conduite principale d’air dentaire (3.25) ou, le cas échéant, au dispositif à raccord rapide

3.22
prise d’air frais

emplacement où la centrale d’air comprimé (3.8) peut aspirer l’air atmosphérique d’une source, située à

l’extérieur du bâtiment s’il y a lieu
3.23
ventilation d’air frais

endroit où l’air frais peut entrer dans le local de la centrale d’air comprimé (3.8) à des fins de ventilation,

de refroidissement et de compression
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ISO 22052:2020(F)
3.24
silencieux d’admission

dispositif qui réduit le niveau de bruit provoqué par l’action d’aspiration du compresseur

3.25
conduite principale d’air dentaire

composant du réseau de canalisations d’un cabinet dentaire utilisé pour transporter l’air dentaire (3.14)

provenant de la centrale d’air comprimé (3.8) jusqu’à la salle de traitement dentaire et d’autres salles

contenant divers dispositifs consommant de l’air dentaire
3.26
séparateur d’huile

dispositif installé dans une centrale d’air comprimé (3.8) lubrifiée à l’huile pour réduire la teneur en

huile de l’air comprimé (3.9)
3.27
local de la centrale d’air comprimé

zone située à l’extérieur de la salle de traitement dentaire d’un cabinet dentaire, dans laquelle est

installé le matériel fournissant de l’air dentaire (3.14) à une ou plusieurs salles de traitement

3.28
point de rosée sous pression
point de rosée (3.18) de l’air à la pression spécifiée
3.29
vanne de régulation de pression

dispositif qui régule la pression maximale d’air fournie à la conduite principale d’air dentaire (3.25)

3.30
dispositif à raccord rapide

dispositif installé au niveau du point de branchement de la centrale d’air comprimé (3.8) pour

débrancher la centrale d’air comprimé de la conduite principale d’air dentaire (3.25) pour les opérations

de maintenance et de mesurage du débit d’air (3.2), de l’humidité de l’air et du niveau de bruit

3.31
vanne d’isolement

dispositif utilisé pour les opérations de maintenance afin d’isoler la centrale d’air comprimé (3.8) de la

conduite principale d’air dentaire (3.25) installée entre le réservoir d’air comprimé (3.6) et la sortie d’air

dentaire (3.15)
3.32
tube d’aspiration

composant permettant de raccorder la prise d’air frais (3.22) à l’entrée d’air frais du compresseur

3.33
séparateur d’eau

composant du système de séchage de l’air (3.3) utilisé pour éliminer l’eau liquide de l’air comprimé (3.9)

4 Classification

Une centrale d’air comprimé doit être classée dans l’un des deux types suivants selon le type de méthode

de lubrification du compresseur:
Type 1: têtes de compresseur lubrifiées à l’huile
Les têtes de compresseur sont lubrifiées à l'huile.

Pour les configurations types de centrale d’air comprimé avec compresseur lubrifié à l’huile, voir B.1.1

et B.1.2, ainsi que les Figures B.1 et B.2.
Type 2: têtes de compresseur non lubrifiées à l’huile
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ISO 22052:2020(F)
Les têtes de compresseur ne sont pas lubrifiées à l'huile.

Pour les configurations types de centrale d’air comprimé avec compresseur non lubrifié à l’huile,

voir B.1.3 et B.1.4, ainsi que les Figures B.3 et B.4.
5 Exigences
5.1 Sécurité électrique

Les compresseurs dentaires et autres composants de la centrale d’air comprimé sont conçus comme un

matériel fixe devant être installé dans un local séparé des salles de traitement dentaire.

Pour empêcher toute conduction électrique entre la centrale d’air comprimé et la conduite principale

d’air dentaire en cas de défaut, les tuyaux ou tubes (tubes souples) qui relient le compresseur dentaire

au point de branchement de la centrale d’air comprimé ou, le cas échéant, au dispositif à raccord rapide,

doivent être en matériau isolant électrique.

Pour une centrale d’air comprimé, les exigences de sécurité de l’IEC 60335-1 s’appliquent.

Les essais doivent être effectués conformément à l’IEC 60335-1.
5.2 Compatibilité électromagnétique

En ce qui concerne la compatibilité électromagnétique (CEM), les exigences suivantes doivent

s’appliquer.
Les exigences relatives à l’immunité de l’IEC 61000-6-2 doivent s’appliquer.
Les essais doivent être réalisés conformément à l’IEC 61000-6-2.
Les exigences relatives à l’émission de l’IEC 61000-6-3 doivent s’appliquer.
Les essais doivent être réalisés conformément à l’IEC 61000-6-3.
5.3 Qualité de l’air dentaire

L’air dentaire produit par la centrale d’air comprimé doit être conforme à la classe de pureté [2:4:2]

selon l’ISO 8573-1.
Explication de la classe de pureté [2:4:2]:

Classe de particules 2: Les nombres de particules dans l’air dentaire sont les suivants:

Taille de particule Nombre de particules par mètre cube
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

Classe d’humidité 4: Le point de rosée sous pression est ≤ +3 °C à une température du milieu

de 20 °C et à une pression constante de 0,7 MPa dans le système (ce qui équivaut à un point de rosée

atmosphérique ≤ −21 °C).

Classe de teneur en huile 2: La teneur en huile de l’air dentaire est ≤ 0,1 mg/m .

Les essais doivent être effectués conformément à 7.2.3.1, 7.2.3.2 et 7.2.3.3.

NOTE 1 Dans l’ISO 8573-1, la classification de l’humidité est définie par rapport à la température du gaz.

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ISO 22052:2020(F)

NOTE 2 Plusieurs systèmes de séchage de l’air engendrent une dépression du point de rosée par rapport à

la température ambiante. Pour faciliter le mesurage, le point de rosée sous pression est défini par rapport à la

température ambiante dans le présent document.

NOTE 3 Conformément à l’ISO 8573-3:1999, 8.1, les conditions de référence pour les indications de l’humidité

sont définies comme suit:
a) température de l’air comprimé 20 °C;
b) pression de l’air comprimé 0,7 MPa.
5.4 Performances
5.4.1 Débit d’air de la centrale d’air comprimé

Le fabricant de la centrale d’air comprimé doit spécifier le débit maximal d’air que la centrale est

destinée à fournir en continu à 0,5 MPa et conformément à l’exigence de qualité de l’air spécifiée en 5.3.

Les mesurages doivent être effectués conformément à 7.2.1 et 7.2.2.
5.4.2 Purgeur de condensat

Le système doit être équipé d’un mécanisme pour évacuer l’eau de condensation de tous les points

où une condensation peut se produire, par exemple un purgeur de condensat au point le plus bas du

réservoir d'air comprimé, du filtre et/ou du sécheur.
La conformité doit être vérifiée conformément à 7.1.2.
5.4.3 Filtre bactérien

Si la centrale d’air comprimé comporte un filtre bactérien, ce dernier doit être calibré pour limiter le

passage des polluants de plus de 0,22 μm avec un taux de rétention de 99,99 %.

Le fabricant doit spécifier la méthode et la périodicité de remplacement de l’élément filtrant.

La conformité doit être vérifiée conformément à 7.1.3.
5.4.4 Niveau de bruit de la centrale d’air comprimé

Le niveau de pression acoustique de la centrale d’air comprimé doit être mesuré et consigné dans le

rapport.
L’essai doit être réalisé conformément à 7.2.4.
5.5 Rapport d’essai

Un rapport d’essai doit être préparé pour consigner les résultats pour toutes les exigences d’essai et

d’inspection applicables spécifiées dans le présent document. L’Annexe C fournit un modèle suggéré

pour le rapport d’essai.
6 Échantillonnage

Un échantillon représentatif de la centrale d’air comprimé doit être soumis à essai.

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ISO 22052:2020(F)
7 Méthodes de mesure et d’essai
7.1 Examen visuel
7.1.1 Généralités
L’examen visuel doit être réalisé avec une acuité visuelle normale.
7.1.2 Examen visuel du matériel

Procéder à l’examen visuel du matériel pour déterminer sa conformité aux exigences.

7.1.3 Examen visuel de la documentation

Procéder à l’examen visuel de la documentation fournie par le fabricant pour déterminer sa conformité

aux exigences.
7.2 Performances du matériel
7.2.1 Conditions générales d’essai
Les essais doi
...

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