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

Status
Published
Public Enquiry End Date
19-Jul-2019
Publication Date
13-Aug-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
28-Jul-2020
Due Date
02-Oct-2020
Completion Date
14-Aug-2020

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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

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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.

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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”.

© ISO 2020 – All rights reserved v
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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
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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).

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
...

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