EN ISO 14644-15:2017
(Main)Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)
ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8).
The following are outside the scope of ISO 14644-15:2017:
- health and safety requirements;
- compatibility with cleaning agents and techniques;
- cleanability;
- biocontamination;
- specific requirements of equipment and materials for processes and products;
- design details of equipment.
Reinräume und zugehörige Reinraumbereiche — Teil 15: Bewertung der Reinraumtauglichkeit von Ausrüstungsgegenständen und Materialien anhand der chemischen Luft- und Oberflächenkonzentration (ISO 14644-15:2017)
Dieses Dokument enthält Anforderungen und Richtlinien zur Bewertung der chemischen luftgetragenen Reinheit von Ausrüstung und Materialien, die für den Gebrauch in Reinräumen und hiermit verbundenen kontrollierten Bereichen vorgesehen sind, die mit der ISO-Norm für Reinheitsklassen anhand der chemischen Konzentration (siehe ISO 14644 8) zusammenhängen.
Gesundheits- und Sicherheitsanforderungen werden von diesem Dokument nicht abgedeckt und könnte von rechtlichen Dokumenten des spezifischen Landes abgedeckt sein.
Folgende Themen sind ausgeschlossen.
— Kompatibilität mit Reinigungsmitteln und -techniken;
— Reinigungsfähigkeit;
— Biokontamination;
— bestimmte Anforderungen an Ausrüstung und Materialien für Prozesse und Produkte;
— Konstruktionsdetails der Ausrüstung
Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de l'aptitude à l'emploi des équipements et des matériaux par la détermination de la concentration chimique aéroportée (ISO 14644-15:2017)
L'ISO 146444-15 :2017 fournit des exigences et des lignes directrices relatives à l'évaluation de la propreté chimique de l'air d'équipements et de matériaux destinés à être utilisés dans des salles propres et des environnements maîtrisés apparentés. Ces exigences et lignes directrices sont liées à la norme ISO relative aux classes de propreté chimique (voir l'ISO 14644‑8).
Les aspects suivants ne font pas partie du domaine d'application:
- exigences de santé et de sécurité;
- compatibilité avec les agents et les techniques de nettoyage;
- nettoyabilité;
- biocontamination;
- exigences spécifiques applicables aux équipements et matériaux en ce qui concerne des procédés et des produits;
- détails de la conception des équipements.
Čiste sobe in podobna nadzorovana okolja - 15. del: Ocena ustreznosti uporabe opreme in materialov na osnovi koncentracije onesnaževal v zraku (ISO 14644-15:2017)
Ta dokument določa zahteve in smernice za ocenjevanje čistoče
opreme in materialov na osnovi koncentracije onesnaževal v zraku za uporabo v čistih sobah in podobnih nadzorovanih
okoljih, ki so povezani s standardom ISO za razrede čistosti zraka na osnovi koncentracije onesnaževal v zraku
(glej ISO 14644-8).
Naslednje ne spada na področje uporabe tega dokumenta:
– zdravstvene in varnostne zahteve;
– združljivost s čistilnimi sredstvi in tehnikami;
– možnost čiščenja;
– biokontaminacija;
– posebne zahteve za opremo in materiale za postopke in proizvode;
– zasnovne podrobnosti opreme.
General Information
Standards Content (sample)
SLOVENSKI STANDARD
SIST EN ISO 14644-15:2018
01-februar-2018
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO2FHQDXVWUH]QRVWLXSRUDEH
RSUHPHLQPDWHULDORYQDRVQRYLNRQFHQWUDFLMHRQHVQDåHYDOY]UDNX,62
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability
for use of equipment and materials by airborne chemical concentration (ISO 14644-
15:2017)Reinräume und zugehörige Reinraumbereiche - Teil 15: Bewertung der
Reinraumtauglichkeit von Geräten und Materialien anhand der chemischen Luft- und
Oberflächenkonzentration (ISO 14644-15:2017)
Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de
l'aptitude à l'emploi des équipements et des matériaux par la détermination de la
concentration chimique aéroportée (ISO 14644-15:2017)Ta slovenski standard je istoveten z: EN ISO 14644-15:2017
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-15:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14644-15:2018
EN ISO 14644-15
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
15: Assessment of suitability for use of equipment and
materials by airborne chemical concentration (ISO 14644-
15:2017)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 15: Évaluation de l'aptitude à l'emploi des 15: Bewertung der Reinraumtauglichkeit von Geräten
équipements et des matériaux par la détermination de und Materialien anhand der chemischen Luft- und
la concentration chimique aéroportée (ISO 14644- Oberflächenkonzentration (ISO 14644-15:2017)
15:2017)This European Standard was approved by CEN on 27 October 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-15:2017 E
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SIST EN ISO 14644-15:2018
EN ISO 14644-15:2017 (E)
Contents Page
European foreword ....................................................................................................................................................... 3
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EN ISO 14644-15:2017 (E)
European foreword
This document (EN ISO 14644-15:2017) has been prepared by Technical Committee ISO/TC 209
“Cleanrooms and associated controlled environments” in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.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 June 2018 and conflicting national standards shall be
withdrawn at the latest by June 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.Endorsement notice
The text of ISO 14644-15:2017 has been approved by CEN as EN ISO 14644-15:2017 without any
modification.---------------------- Page: 5 ----------------------
SIST EN ISO 14644-15:2018
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SIST EN ISO 14644-15:2018
INTERNATIONAL ISO
STANDARD 14644-15
First edition
2017-10
Cleanrooms and associated controlled
environments —
Part 15:
Assessment of suitability for use of
equipment and materials by airborne
chemical concentration
Salles propres et environnements maîtrisés apparentés —
Partie 15: Évaluation de l'aptitude à l'emploi des équipements et
des matériaux par la détermination de la concentration chimique
aéroportée
Reference number
ISO 14644-15:2017(E)
ISO 2017
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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction ..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 Symbols .......................................................................................................................................................................................................................... 4
5 Test setup ..................................................................................................................................................................................................................... 5
5.1 General ........................................................................................................................................................................................................... 5
5.2 Closed design ............................................................................................................................................................................................ 5
5.3 Closed design special application ........................................................................................................................................... 6
5.4 Open design ............................................................................................................................................................................................... 7
6 Representative mode ....................................................................................................................................................................................... 7
6.1 Equipment ................................................................................................................................................................................................... 7
6.2 Material ......................................................................................................................................................................................................... 7
7 Visual inspection .................................................................................................................................................................................................. 8
7.1 General ........................................................................................................................................................................................................... 8
7.2 Equipment ................................................................................................................................................................................................... 8
7.3 Material ......................................................................................................................................................................................................... 8
8 Test description ..................................................................................................................................................................................................... 9
9 Calculation of the measured concentrations .......................................................................................................................... 9
10 Calculation of specific emission rate ............................................................................................................................................10
10.1 Calculation of specific emission rate — Closed design .....................................................................................10
10.2 Calculation of specific emission rate — Open design .........................................................................................11
11 Assessment ..............................................................................................................................................................................................................11
11.1 General ........................................................................................................................................................................................................11
11.2 Required input data .........................................................................................................................................................................12
11.3 Calculation to determine the effect on a cleanroom or controlled zone ............................................12
11.4 Assessment of the suitability of material(s) or equipment for an existingcleanroom or controlled zone .................................................................................................................................................13
12 Documentation ....................................................................................................................................................................................................13
12.1 General ........................................................................................................................................................................................................13
12.2 Common documentation requirements .........................................................................................................................13
12.3 Test documentation .........................................................................................................................................................................14
12.4 Visual inspection ................................................................................................................................................................................14
12.4.1 Equipment ..........................................................................................................................................................................14
12.4.2 Materials ..............................................................................................................................................................................14
Annex A (informative) Example calculation for suitability assessment of one equipment
(existing installation) ...................................................................................................................................................................................15
Annex B (informative) Example calculation for suitability assessment of wall material
(existing cleanroom/clean zone installation) ....................................................................................................................17
Annex C (informative) Suitability assessment of a combination of equipment and floor
material in a cleanroom to be designed ....................................................................................................................................19
Bibliography .............................................................................................................................................................................................................................21
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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.A list of all parts in the ISO 14644 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved
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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit
from the control of contamination include those in such industries as aerospace, microelectronics,
optics, nuclear, and life sciences (pharmaceuticals, medical devices, food, healthcare).
This document addresses the cleanroom classification of air cleanliness by chemical concentration to
the suitability of equipment for use in cleanrooms and associated controlled environments.
Examples and suitability assessments are given in Annexes A, B and C.© ISO 2017 – All rights reserved v
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SIST EN ISO 14644-15:2018
INTERNATIONAL STANDARD ISO 14644-15:2017(E)
Cleanrooms and associated controlled environments —
Part 15:
Assessment of suitability for use of equipment and
materials by airborne chemical concentration
1 Scope
This document provides requirements and guidelines for assessing the chemical airborne cleanliness
of equipment and materials which are foreseen to be used in cleanrooms and associated controlled
environments which are linked to the ISO standard for cleanliness classes by chemical concentration
(see ISO 14644-8).The following are outside the scope of this document:
— health and safety requirements;
— compatibility with cleaning agents and techniques;
— cleanability;
— biocontamination;
— specific requirements of equipment and materials for processes and products;
— design details of equipment.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-8:2013, Cleanrooms and associated controlled environments — Part 8: Classification of air
cleanliness by chemical concentration (ACC)3 Terms and definitions
For the purposes of this document, the following terms and definitions 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 chemical contamination
any non-particulate chemical specie(s) in the air that can, by its chemical nature, adversely affect the
product, process or equipment[SOURCE: ISO 14644-8:2013, 3.1.3, modified — “substance” has been replaced by “non-particulate
chemical specie(s)”.]© ISO 2017 – All rights reserved 1
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ISO 14644-15:2017(E)
3.2
air cleanliness by chemical concentration
ACC
level of air cleanliness (3.5) by chemical concentration, expressed in terms of an ISO-ACC Class N, which
represents the maximum allowable concentration of a given chemical species or a group of chemical
species, expressed in grams per cubic metreNote 1 to entry: This definition does not include macromolecules of biological origin, which are judged to be
particles.[SOURCE: ISO 14644-8:2013, 3.1.2]
3.3
breakthrough volume
maximum purge gas (3.14) volume that can be drawn through a trapping system without loss of analyte
at a specific temperature3.4
chemical contamination
non-particulate substances that can have a deleterious effect on the product, process or equipment
[SOURCE: ISO 14644-8:2013, 3.1.1]3.5
cleanliness
condition not exceeding a specified level of contamination
3.6
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation, and
retention of particles inside the roomNote 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations may also be
specified and controlled.Note 3 to entry: Other relevant physical parameters may also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.[SOURCE: ISO 14644-1:2015, 3.1.1]
3.7
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone (3.8) when used as
intendedNote 1 to entry: For the purposes of this document, the assessment is based on air chemical concentration.
Note 2 to entry: The definition refers to the use of equipment and materials.[SOURCE: ISO 14644-14:2016, 3.3, modified — Note 2 has been added.]
3.8
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation, and
retention of contaminants inside the spaceNote 1 to entry: The class of airborne particle concentration is specified.
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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations may also be
specified and controlled.Note 3 to entry: A clean zone(s) may be a defined space within a cleanroom or may be achieved by a separative
device. Such a device may be located inside or outside a cleanroom.Note 4 to entry: Other relevant physical parameters may also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.[SOURCE: ISO 14644-1:2015, 3.1.2]
3.9
controlled zone
designated space in which the concentration of at least one contamination category (particles, chemical,
biocontamination) in air and/or on surfaces is controlled and specified and which is constructed and
used in a manner to minimize the introduction and impact of contaminationNote 1 to entry: Levels of cleanliness attributes such as chemical and viable concentrations in the air or
cleanliness in terms of particle, chemical and viable concentrations on surfaces may be specified by class(es).
Note 2 to entry: Other relevant parameters may also be controlled as necessary, e.g. temperature, humidity and
pressure, vibration and electrostatic.Note 3 to entry: A controlled zone can be a defined space within a cleanroom or may be achieved by a separative
device. Such a device may be located inside or outside a cleanroom.3.10
emission
contaminants that are discharged into the environment
[SOURCE: ISO 2889:2010, 3.30]
Note 1 to entry: For the purposes of this document, only chemical emission is considered.
3.11emission rate
rate describing the mass of one or more volatile chemical(s) emitted from the equipment or material
per time unit3.12
equipment
system designed for specific function(s), integrating materials, components and/or controls
EXAMPLE Testing and manufacturing equipment and machinery; equipment for transport and handling;
storage units; tools; furniture; doors; ceilings; IT hardware; handling robots.[SOURCE: ISO 14644-14:2017, 3.6]
3.13
material
single substance or composite
Note 1 to entry: It might be necessary to provide material in a representative form to enable testing.
3.14purge gas
gas or gas mixture to carry contaminant to a defined outlet
Note 1 to entry: In a controlled or clean zone (3.8) or a cleanroom (3.6), filtered air might be used as purge gas.
Note 2 to entry: A test environment (3.18) might be purged with air or other gases or gas mixtures to carry the
contaminant to a trapping system or measurement device.© ISO 2017 – All rights reserved 3
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ISO 14644-15:2017(E)
3.15
representative form
material sample produced to represent the intrinsic physical and chemical properties of an object
3.16representative mode
mode of operation that reflects the intended use of the equipment
3.17
specific emission rate
normalized mass flow of chemical contaminants emitted from a test object
Note 1 to entry: Material-specific emission rate (3.11) is based on surface area.
Note 2 to entry: Equipment-specific emission rate is based on one single unit of equipment.
3.18test environment
space in which the test is carried out, described by a set of parameters
[SOURCE: ISO 14644-14:2017, 3.7]
4 Symbols
Symbol Meaning Unit
p Background concentration in the test environment without the g/m
test object
p Concentration in the test environment with the test object g/m
p Chemical mass concentration in the cleanroom/controlled zone g/m
p Chemical mass concentration of the make up air g/m
F Sampling flow rate background measurement m /s
F Sampling flow rate object measurement m /s
m Total sampled mass emitted from the test environment with g
test object
m Total sampled mass emitted from the test environment without g
test object
t Sampling duration object measurement s
t Sampling duration background measurement s
x Specific metric related to the test object m for materials
“unit” for equipment
x Quantity related to the assessed object m for materials
“unit” for equipment
q Specific emission rate of the test object g/(m s) or g/(unit · s)
n Air change rate through the test environment 1/s
n Make up air change rate 1/s
n Recirculated air change rate 1/s
V Volume of air in the cleanroom/ controlled zone m
V Volume of the test environment m
α Specified efficiency of the chemical filtration system —
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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)
5 Test setup
5.1 General
The test setup shall be designed for collecting representative samples of contaminants within the test
environment in order to assess specific emission rates from equipment and/or materials. It can be
designed as closed (see Figure 1), closed special application (see Figure 2) or open (see Figure 3).
Closed design is used for low specific emission rates and is the preferred method. Larger test objects
and equipment in operation may require the use of an open design test setup (see 5.4).
The tolerance of the temperature sensor shall be ±2 °C.The tolerance of the flow meter shall be ±5 %.
The humidity of the purge gas shall be specified and controlled.
The sampling of ACC-emissions is performed by purging a defined gas volume onto a suitable
trapping system, e.g. an adsorber. Multiple trapping systems can be used to collect different species of
contaminants.ISO 14644-8:2013, Annex C gives an overview regarding trapping and measuring techniques.
NOTE For considerations regarding VOC-sampling, see ISO 16000-6 and ISO 16017-1.5.2 Closed design
Key
1 purge gas source 7 trapping system(s)
2 valve for purge gas supply 8 flow meter(s)
3 connection to chamber 9 valve(s) for flow control
4 test chamber 10 pump (option)
5 temperature sensor 11 mixing device (option)
6 material sample or equipment
NOTE Depending on the size of the test environment, a mixing device can be installed to enable
homogeneous mixing.Figure 1 — Closed design
Using a closed design requires a flow-controlled purge gas supply and a flow meter installed after the
trapping system. The purge gas flow shall be controlled by a valve. In addition, a pump may be used
downstream of the flow meter.© ISO 2017 – All rights reserved 5
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ISO 14644-15:2017(E)
5.3 Closed design special application
Key
1 purge gas source 7 trapping system(s)
2 valve for purge gas supply 8 flow meter(s)
3 connection to chamber 9 valve(s) for flow control
4 test chamber 10 pump (option)
5 temperature sensor 11 mixing device (option)
6 material sample
Figure 2 — Closed design special application
This setup is used for material samples with even surfaces. Both the enclosure and the material sample
surface shall form a gastight test environment.To obtain a background analysis, substitute test material with glass or stainless steel pla
...
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